<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03262701</url>
  </required_header>
  <id_info>
    <org_study_id>5180025</org_study_id>
    <nct_id>NCT03262701</nct_id>
  </id_info>
  <brief_title>Adjunctive Hydrogen Peroxide for Periodontal Therapy</brief_title>
  <acronym>AHP</acronym>
  <official_title>Custom Tray Application of Peroxide Gel as an Adjunct to Scaling and Root Planing in the Treatment of Periodontitis: A 6-Month Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Loma Linda University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Loma Linda University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      There have been many adjunctive treatments for the additional clinical benefits to scaling&#xD;
      and root planing (SRP) in the treatment of chronic periodontitis. Topical hydrogen peroxide&#xD;
      (HP) delivered in a custom fabricated tray has been shown to improve pocket depth (PD) and&#xD;
      inflammation. The purpose of this study is to assess the adjunctive treatment outcome of HP&#xD;
      gel in custom tray application in individuals with chronic periodontitis receiving SRP. The&#xD;
      purpose of this investigator-initiated study is to evaluate and compare the clinical effects&#xD;
      of scaling and root planing (SRP) combined with local delivery of 1.7% hydrogen peroxide (HP)&#xD;
      gel in customized trays to that of SRP alone.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hydrogen peroxide (HP) has been used in for wound debridement and oral rinses in dentistry&#xD;
      for a few decades. It is widely available in a bottle of 3% in liquid. The use of hydrogen&#xD;
      peroxide in gel type in 1.7% as an adjunct to conventional periodontal therapy has been&#xD;
      introduced but there are limited information on the efficacy. The current study is to design&#xD;
      to evaluate the adjunctive treatment outcome of hydrogen peroxide gel in custom tray&#xD;
      application in individuals with chronic periodontitis receiving non surgical therapy, scaling&#xD;
      and root planing(SRP). To test the adjunct effect of HP gel in tray, there will be three&#xD;
      parallel arms, one with the gel for the period of 26 week, one with the gel for 13 weeks and&#xD;
      control group without the gel.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    COVID&#xD;
  </why_stopped>
  <start_date type="Actual">April 2, 2018</start_date>
  <completion_date type="Actual">February 8, 2021</completion_date>
  <primary_completion_date type="Actual">February 8, 2021</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Periodontal Pocket Depth Reduction</measure>
    <time_frame>Change between baseline and Week 4</time_frame>
    <description>Periodontal pocket depth reduction as measured by the periodontal probe from the gingival margin to the bottom of the periodontal pocket measured in millimeters.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Periodontal Pocket Depth Reduction</measure>
    <time_frame>Change between baseline and Week 13</time_frame>
    <description>Periodontal pocket depth reduction as measured by the periodontal probe from the gingival margin to the bottom of the periodontal pocket measured in millimeters.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Periodontal Pocket Depth Reduction</measure>
    <time_frame>Change between baseline and Week 26</time_frame>
    <description>Periodontal pocket depth reduction as measured by the periodontal probe from the gingival margin to the bottom of the periodontal pocket measured in millimeters.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Clinical Attachment Level</measure>
    <time_frame>Change between baseline and Week 26</time_frame>
    <description>Change in clinical attachment level measured by using a periodontal probe with a stent used for reproducible reference in millimeters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Bleeding on Probing</measure>
    <time_frame>Change between baseline and Week 26</time_frame>
    <description>Change in bleeding on probing measured by the presence of bleeding upon probing a periodontal pocket using a periodontal probe within 30 seconds measured in percentage.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Periodontitis, Chronic</condition>
  <arm_group>
    <arm_group_label>Hydrogen Peroxide gel for 13weeks</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis and be given 1.7% hydrogen peroxide gel, oral, 0.75g, twice-daily for 15 minutes for 13 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hydrogen Peroxide gel for 26weeks</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis and be given 1.7% hydrogen peroxide gel, oral, 0.75g, twice-daily for 15 minutes for 26 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Scaling and Root Planing</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis without any interventional hydrogen peroxide application in one or two visits.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hydrogen Peroxide Gel, 13 weeks</intervention_name>
    <description>13 weeks of twice-daily use of custom tray application of 1.7% peroxide gel as an adjunct to scaling and root planing in the treatment of chronic periodontitis.</description>
    <arm_group_label>Hydrogen Peroxide gel for 13weeks</arm_group_label>
    <other_name>Perio Protect®</other_name>
    <other_name>1.7% hydrogen peroxide gel</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hydrogen Peroxide Gel, 26 weeks</intervention_name>
    <description>26 weeks of twice-daily use of custom tray application of 1.7% peroxide gel as an adjunct to scaling and root planing in the treatment of chronic periodontitis.</description>
    <arm_group_label>Hydrogen Peroxide gel for 26weeks</arm_group_label>
    <other_name>Perio Protect®</other_name>
    <other_name>1.7% hydrogen peroxide gel</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Scaling and Root planing group</intervention_name>
    <description>Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis without custom tray application of 1.7% peroxide gel</description>
    <arm_group_label>Scaling and Root Planing</arm_group_label>
    <other_name>SRP group control</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Volunteers who can read and sign the Research Information and Consent Form&#xD;
&#xD;
          2. Male and female adults, aged ≥18 years.&#xD;
&#xD;
          3. The presence of twenty or more (at least 2 posterior teeth in contact per quadrant,&#xD;
             one of which is a molar), natural teeth in a good state of repair with scorable&#xD;
             surfaces.&#xD;
&#xD;
          4. Show evidence of chronic periodontitis, minimum of one site with PD ≥5mm and Bleeding&#xD;
             on Probing (BOP) in at least two quadrants and no mechanical debridement for six&#xD;
             months prior to the start of the study.&#xD;
&#xD;
          5. Agree to comply with the conditions and schedule of the study, i.e., willing to use&#xD;
             the assigned products (see Treatment Phase and Standardize Oral Hygiene Instruction)&#xD;
             according to instructions and be available for appointments.&#xD;
&#xD;
          6. Agree not to have a dental prophylaxis, professional whitening treatment, or any other&#xD;
             elective, non-emergency dental procedure (other than those provided) at any time&#xD;
             during the study.&#xD;
&#xD;
          7. Willing to refrain from using mouth rinses and tooth whitening products for the&#xD;
             duration of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any systemic conditions or medication intake that can alter periodontal status (e.g.&#xD;
             uncontrolled diabetes (with &lt;3 month recent HbA1c of &gt;8.5%), anti-seizure medication&#xD;
             and immunosuppressants, and calcium channel blockers with clinical evidence of&#xD;
             drug-influenced gingival enlargement)&#xD;
&#xD;
          2. Immune-compromised state.&#xD;
&#xD;
          3. Any current heavy smoking habits (&gt;10 cigarettes/day)&#xD;
&#xD;
          4. Any medical condition or history requiring prophylactic antibiotic coverage prior to&#xD;
             dental treatment.&#xD;
&#xD;
          5. Females who are lactating or pregnant (as determined by medical history) or planning&#xD;
             to become pregnant for the duration of the study.&#xD;
&#xD;
          6. Physical limitations/restrictions compromising oral hygiene procedures.&#xD;
&#xD;
          7. The presence of significant oral soft tissue pathology and/or lesions associated with&#xD;
             ill-fitting appliances or restorations.&#xD;
&#xD;
          8. Tooth mobility associated with advanced periodontal disease (e.g. score of &gt;2 using&#xD;
             Miller Classification).&#xD;
&#xD;
          9. Any temporomandibular joint disorders.&#xD;
&#xD;
         10. Grossly carious, orthodontically banded, and third molars will not be included in the&#xD;
             tooth count.&#xD;
&#xD;
         11. The presence of any significantly tipped, crowded, or largely defective restorations.&#xD;
&#xD;
         12. Any extreme adverse events relating to the use of hydrogen peroxide gel (e.g.&#xD;
             prolonged&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yoon Jeong Kim, DDS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Loma Linda University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Loma Linda University Health</name>
      <address>
        <city>Loma Linda</city>
        <state>California</state>
        <zip>92354</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>August 22, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <results_first_submitted>May 10, 2022</results_first_submitted>
  <results_first_submitted_qc>November 29, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">December 21, 2022</results_first_posted>
  <last_update_submitted>November 29, 2022</last_update_submitted>
  <last_update_submitted_qc>November 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periodontitis</mesh_term>
    <mesh_term>Chronic Periodontitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hydrogen Peroxide</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 18, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/01/NCT03262701/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Hydrogen Peroxide Gel for 13weeks</title>
          <description>Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis and be given 1.7% hydrogen peroxide gel, oral, 0.75g, twice-daily for 15 minutes for 13 weeks.&#xD;
Hydrogen Peroxide Gel, 13 weeks: 13 weeks of twice-daily use of custom tray application of 1.7% peroxide gel as an adjunct to scaling and root planing in the treatment of chronic periodontitis.</description>
        </group>
        <group group_id="P2">
          <title>Hydrogen Peroxide Gel for 26weeks</title>
          <description>Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis and be given 1.7% hydrogen peroxide gel, oral, 0.75g, twice-daily for 15 minutes for 26 weeks.&#xD;
Hydrogen Peroxide Gel, 26 weeks: 26 weeks of twice-daily use of custom tray application of 1.7% peroxide gel as an adjunct to scaling and root planing in the treatment of chronic periodontitis.</description>
        </group>
        <group group_id="P3">
          <title>Scaling and Root Planing</title>
          <description>Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis without any interventional hydrogen peroxide application in one or two visits.&#xD;
Scaling and Root planing group: Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis without custom tray application of 1.7% peroxide gel</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="17"/>
                <participants group_id="P3" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="13"/>
                <participants group_id="P3" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Hydrogen Peroxide Gel for 13weeks</title>
          <description>Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis and be given 1.7% hydrogen peroxide gel, oral, 0.75g, twice-daily for 15 minutes for 13 weeks.&#xD;
Hydrogen Peroxide Gel, 13 weeks: 13 weeks of twice-daily use of custom tray application of 1.7% peroxide gel as an adjunct to scaling and root planing in the treatment of chronic periodontitis.</description>
        </group>
        <group group_id="B2">
          <title>Hydrogen Peroxide Gel for 26weeks</title>
          <description>Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis and be given 1.7% hydrogen peroxide gel, oral, 0.75g, twice-daily for 15 minutes for 26 weeks.&#xD;
Hydrogen Peroxide Gel, 26 weeks: 26 weeks of twice-daily use of custom tray application of 1.7% peroxide gel as an adjunct to scaling and root planing in the treatment of chronic periodontitis.</description>
        </group>
        <group group_id="B3">
          <title>Scaling and Root Planing</title>
          <description>Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis without any interventional hydrogen peroxide application in one or two visits.&#xD;
Scaling and Root planing group: Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis without custom tray application of 1.7% peroxide gel</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="14"/>
            <count group_id="B2" value="17"/>
            <count group_id="B3" value="8"/>
            <count group_id="B4" value="39"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="14"/>
                    <count group_id="B2" value="17"/>
                    <count group_id="B3" value="8"/>
                    <count group_id="B4" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="14"/>
                    <count group_id="B2" value="17"/>
                    <count group_id="B3" value="8"/>
                    <count group_id="B4" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="48.3" spread="13.5"/>
                    <measurement group_id="B2" value="54.5" spread="15.4"/>
                    <measurement group_id="B3" value="57.1" spread="15.7"/>
                    <measurement group_id="B4" value="52.7" spread="14.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="14"/>
                    <count group_id="B2" value="17"/>
                    <count group_id="B3" value="8"/>
                    <count group_id="B4" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="14"/>
                    <count group_id="B2" value="17"/>
                    <count group_id="B3" value="8"/>
                    <count group_id="B4" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Bleeding On Probing</title>
          <units>percent</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="14"/>
                    <count group_id="B2" value="17"/>
                    <count group_id="B3" value="8"/>
                    <count group_id="B4" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="57.1" spread="37.2"/>
                    <measurement group_id="B2" value="66.9" spread="11.9"/>
                    <measurement group_id="B3" value="35.2" spread="16.8"/>
                    <measurement group_id="B4" value="53.1" spread="22.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Pocket Depth</title>
          <units>millimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="14"/>
                    <count group_id="B2" value="17"/>
                    <count group_id="B3" value="8"/>
                    <count group_id="B4" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.11" spread="1.43"/>
                    <measurement group_id="B2" value="3.41" spread="1.16"/>
                    <measurement group_id="B3" value="3.82" spread="1.29"/>
                    <measurement group_id="B4" value="3.78" spread="1.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Relative Attachment Level</title>
          <units>millimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="14"/>
                    <count group_id="B2" value="17"/>
                    <count group_id="B3" value="8"/>
                    <count group_id="B4" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.97" spread="1.29"/>
                    <measurement group_id="B2" value="7.11" spread="0.83"/>
                    <measurement group_id="B3" value="6.75" spread="0.16"/>
                    <measurement group_id="B4" value="6.94" spread="0.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Periodontal Pocket Depth Reduction</title>
        <description>Periodontal pocket depth reduction as measured by the periodontal probe from the gingival margin to the bottom of the periodontal pocket measured in millimeters.</description>
        <time_frame>Change between baseline and Week 4</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hydrogen Peroxide Gel for 13weeks</title>
            <description>Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis and be given 1.7% hydrogen peroxide gel, oral, 0.75g, twice-daily for 15 minutes for 13 weeks.&#xD;
Hydrogen Peroxide Gel, 13 weeks: 13 weeks of twice-daily use of custom tray application of 1.7% peroxide gel as an adjunct to scaling and root planing in the treatment of chronic periodontitis.</description>
          </group>
          <group group_id="O2">
            <title>Hydrogen Peroxide Gel for 26weeks</title>
            <description>Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis and be given 1.7% hydrogen peroxide gel, oral, 0.75g, twice-daily for 15 minutes for 26 weeks.&#xD;
Hydrogen Peroxide Gel, 26 weeks: 26 weeks of twice-daily use of custom tray application of 1.7% peroxide gel as an adjunct to scaling and root planing in the treatment of chronic periodontitis.</description>
          </group>
          <group group_id="O3">
            <title>Scaling and Root Planing</title>
            <description>Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis without any interventional hydrogen peroxide application in one or two visits.&#xD;
Scaling and Root planing group: Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis without custom tray application of 1.7% peroxide gel</description>
          </group>
        </group_list>
        <measure>
          <title>Periodontal Pocket Depth Reduction</title>
          <description>Periodontal pocket depth reduction as measured by the periodontal probe from the gingival margin to the bottom of the periodontal pocket measured in millimeters.</description>
          <units>millimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="13"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.05" spread="0.16"/>
                    <measurement group_id="O2" value="-0.16" spread="0.05"/>
                    <measurement group_id="O3" value="0.05" spread="0.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Periodontal Pocket Depth Reduction</title>
        <description>Periodontal pocket depth reduction as measured by the periodontal probe from the gingival margin to the bottom of the periodontal pocket measured in millimeters.</description>
        <time_frame>Change between baseline and Week 13</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hydrogen Peroxide Gel for 13weeks</title>
            <description>Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis and be given 1.7% hydrogen peroxide gel, oral, 0.75g, twice-daily for 15 minutes for 13 weeks.&#xD;
Hydrogen Peroxide Gel, 13 weeks: 13 weeks of twice-daily use of custom tray application of 1.7% peroxide gel as an adjunct to scaling and root planing in the treatment of chronic periodontitis.</description>
          </group>
          <group group_id="O2">
            <title>Hydrogen Peroxide Gel for 26weeks</title>
            <description>Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis and be given 1.7% hydrogen peroxide gel, oral, 0.75g, twice-daily for 15 minutes for 26 weeks.&#xD;
Hydrogen Peroxide Gel, 26 weeks: 26 weeks of twice-daily use of custom tray application of 1.7% peroxide gel as an adjunct to scaling and root planing in the treatment of chronic periodontitis.</description>
          </group>
          <group group_id="O3">
            <title>Scaling and Root Planing</title>
            <description>Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis without any interventional hydrogen peroxide application in one or two visits.&#xD;
Scaling and Root planing group: Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis without custom tray application of 1.7% peroxide gel</description>
          </group>
        </group_list>
        <measure>
          <title>Periodontal Pocket Depth Reduction</title>
          <description>Periodontal pocket depth reduction as measured by the periodontal probe from the gingival margin to the bottom of the periodontal pocket measured in millimeters.</description>
          <units>millimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="13"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.69" spread="0.31"/>
                    <measurement group_id="O2" value="-0.54" spread="0.33"/>
                    <measurement group_id="O3" value="-0.34" spread="0.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Periodontal Pocket Depth Reduction</title>
        <description>Periodontal pocket depth reduction as measured by the periodontal probe from the gingival margin to the bottom of the periodontal pocket measured in millimeters.</description>
        <time_frame>Change between baseline and Week 26</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hydrogen Peroxide Gel for 13weeks</title>
            <description>Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis and be given 1.7% hydrogen peroxide gel, oral, 0.75g, twice-daily for 15 minutes for 13 weeks.&#xD;
Hydrogen Peroxide Gel, 13 weeks: 13 weeks of twice-daily use of custom tray application of 1.7% peroxide gel as an adjunct to scaling and root planing in the treatment of chronic periodontitis.</description>
          </group>
          <group group_id="O2">
            <title>Hydrogen Peroxide Gel for 26weeks</title>
            <description>Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis and be given 1.7% hydrogen peroxide gel, oral, 0.75g, twice-daily for 15 minutes for 26 weeks.&#xD;
Hydrogen Peroxide Gel, 26 weeks: 26 weeks of twice-daily use of custom tray application of 1.7% peroxide gel as an adjunct to scaling and root planing in the treatment of chronic periodontitis.</description>
          </group>
          <group group_id="O3">
            <title>Scaling and Root Planing</title>
            <description>Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis without any interventional hydrogen peroxide application in one or two visits.&#xD;
Scaling and Root planing group: Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis without custom tray application of 1.7% peroxide gel</description>
          </group>
        </group_list>
        <measure>
          <title>Periodontal Pocket Depth Reduction</title>
          <description>Periodontal pocket depth reduction as measured by the periodontal probe from the gingival margin to the bottom of the periodontal pocket measured in millimeters.</description>
          <units>millimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="13"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.70" spread="0.33"/>
                    <measurement group_id="O2" value="-0.49" spread="0.21"/>
                    <measurement group_id="O3" value="-0.30" spread="0.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Clinical Attachment Level</title>
        <description>Change in clinical attachment level measured by using a periodontal probe with a stent used for reproducible reference in millimeters.</description>
        <time_frame>Change between baseline and Week 26</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hydrogen Peroxide Gel for 13weeks</title>
            <description>Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis and be given 1.7% hydrogen peroxide gel, oral, 0.75g, twice-daily for 15 minutes for 13 weeks.&#xD;
Hydrogen Peroxide Gel, 13 weeks: 13 weeks of twice-daily use of custom tray application of 1.7% peroxide gel as an adjunct to scaling and root planing in the treatment of chronic periodontitis.</description>
          </group>
          <group group_id="O2">
            <title>Hydrogen Peroxide Gel for 26weeks</title>
            <description>Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis and be given 1.7% hydrogen peroxide gel, oral, 0.75g, twice-daily for 15 minutes for 26 weeks.&#xD;
Hydrogen Peroxide Gel, 26 weeks: 26 weeks of twice-daily use of custom tray application of 1.7% peroxide gel as an adjunct to scaling and root planing in the treatment of chronic periodontitis.</description>
          </group>
          <group group_id="O3">
            <title>Scaling and Root Planing</title>
            <description>Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis without any interventional hydrogen peroxide application in one or two visits.&#xD;
Scaling and Root planing group: Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis without custom tray application of 1.7% peroxide gel</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Clinical Attachment Level</title>
          <description>Change in clinical attachment level measured by using a periodontal probe with a stent used for reproducible reference in millimeters.</description>
          <units>millimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="13"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.25" spread="0.65"/>
                    <measurement group_id="O2" value="-0.42" spread="0.13"/>
                    <measurement group_id="O3" value="-0.23" spread="0.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Bleeding on Probing</title>
        <description>Change in bleeding on probing measured by the presence of bleeding upon probing a periodontal pocket using a periodontal probe within 30 seconds measured in percentage.</description>
        <time_frame>Change between baseline and Week 26</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hydrogen Peroxide Gel for 13weeks</title>
            <description>Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis and be given 1.7% hydrogen peroxide gel, oral, 0.75g, twice-daily for 15 minutes for 13 weeks.&#xD;
Hydrogen Peroxide Gel, 13 weeks: 13 weeks of twice-daily use of custom tray application of 1.7% peroxide gel as an adjunct to scaling and root planing in the treatment of chronic periodontitis.</description>
          </group>
          <group group_id="O2">
            <title>Hydrogen Peroxide Gel for 26weeks</title>
            <description>Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis and be given 1.7% hydrogen peroxide gel, oral, 0.75g, twice-daily for 15 minutes for 26 weeks.&#xD;
Hydrogen Peroxide Gel, 26 weeks: 26 weeks of twice-daily use of custom tray application of 1.7% peroxide gel as an adjunct to scaling and root planing in the treatment of chronic periodontitis.</description>
          </group>
          <group group_id="O3">
            <title>Scaling and Root Planing</title>
            <description>Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis without any interventional hydrogen peroxide application in one or two visits.&#xD;
Scaling and Root planing group: Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis without custom tray application of 1.7% peroxide gel</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Bleeding on Probing</title>
          <description>Change in bleeding on probing measured by the presence of bleeding upon probing a periodontal pocket using a periodontal probe within 30 seconds measured in percentage.</description>
          <units>percent</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="13"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-24.1" spread="23.2"/>
                    <measurement group_id="O2" value="-34.2" spread="5.95"/>
                    <measurement group_id="O3" value="-14.2" spread="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Hydrogen Peroxide Gel for 13weeks</title>
          <description>Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis and be given 1.7% hydrogen peroxide gel, oral, 0.75g, twice-daily for 15 minutes for 13 weeks.&#xD;
Hydrogen Peroxide Gel, 13 weeks: 13 weeks of twice-daily use of custom tray application of 1.7% peroxide gel as an adjunct to scaling and root planing in the treatment of chronic periodontitis.</description>
        </group>
        <group group_id="E2">
          <title>Hydrogen Peroxide Gel for 26weeks</title>
          <description>Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis and be given 1.7% hydrogen peroxide gel, oral, 0.75g, twice-daily for 15 minutes for 26 weeks.&#xD;
Hydrogen Peroxide Gel, 26 weeks: 26 weeks of twice-daily use of custom tray application of 1.7% peroxide gel as an adjunct to scaling and root planing in the treatment of chronic periodontitis.</description>
        </group>
        <group group_id="E3">
          <title>Scaling and Root Planing</title>
          <description>Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis without any interventional hydrogen peroxide application in one or two visits.&#xD;
Scaling and Root planing group: Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis without custom tray application of 1.7% peroxide gel</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Due to COVID lockdown, the enrollment and study discontinued abruptly.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Yoon Jeong Kim</name_or_title>
      <organization>Loma Linda University School of Dentistry</organization>
      <phone>(909) 558-4610</phone>
      <email>yjkim02d2@llu.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03262701
org study id: 5180025
nct id: NCT03262701
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
There have been many adjunctive treatments for the additional clinical benefits to scaling
      and root planing (SRP) in the treatment of chronic periodontitis. Topical hydrogen peroxide
      (HP) delivered in a custom fabricated tray has been shown to improve pocket depth (PD) and
      inflammation. The purpose of this study is to assess the adjunctive treatment outcome of HP
      gel in custom tray application in individuals with chronic periodontitis receiving SRP. The
      purpose of this investigator-initiated study is to evaluate and compare the clinical effects
      of scaling and root planing (SRP) combined with local delivery of 1.7% hydrogen peroxide (HP)
      gel in customized trays to that of SRP alone.
Hydrogen peroxide (HP) has been used in for wound debridement and oral rinses in dentistry
      for a few decades. It is widely available in a bottle of 3% in liquid. The use of hydrogen
      peroxide in gel type in 1.7% as an adjunct to conventional periodontal therapy has been
      introduced but there are limited information on the efficacy. The current study is to design
      to evaluate the adjunctive treatment outcome of hydrogen peroxide gel in custom tray
      application in individuals with chronic periodontitis receiving non surgical therapy, scaling
      and root planing(SRP). To test the adjunct effect of HP gel in tray, there will be three
      parallel arms, one with the gel for the period of 26 week, one with the gel for 13 weeks and
      control group without the gel.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Periodontal Pocket Depth Reduction
time frame: Change between baseline and Week 4
description: Periodontal pocket depth reduction as measured by the periodontal probe from the gingival margin to the bottom of the periodontal pocket measured in millimeters.
measure: Periodontal Pocket Depth Reduction
time frame: Change between baseline and Week 13
description: Periodontal pocket depth reduction as measured by the periodontal probe from the gingival margin to the bottom of the periodontal pocket measured in millimeters.
measure: Periodontal Pocket Depth Reduction
time frame: Change between baseline and Week 26
description: Periodontal pocket depth reduction as measured by the periodontal probe from the gingival margin to the bottom of the periodontal pocket measured in millimeters.
measure: Change in Clinical Attachment Level
time frame: Change between baseline and Week 26
description: Change in clinical attachment level measured by using a periodontal probe with a stent used for reproducible reference in millimeters.
measure: Change in Bleeding on Probing
time frame: Change between baseline and Week 26
description: Change in bleeding on probing measured by the presence of bleeding upon probing a periodontal pocket using a periodontal probe within 30 seconds measured in percentage.
arm group label: Hydrogen Peroxide gel for 13weeks
arm group type: Experimental
description: Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis and be given 1.7% hydrogen peroxide gel, oral, 0.75g, twice-daily for 15 minutes for 13 weeks.
arm group label: Hydrogen Peroxide gel for 26weeks
arm group type: Experimental
description: Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis and be given 1.7% hydrogen peroxide gel, oral, 0.75g, twice-daily for 15 minutes for 26 weeks.
arm group label: Scaling and Root Planing
arm group type: Other
description: Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis without any interventional hydrogen peroxide application in one or two visits.
intervention type: Drug
intervention name: Hydrogen Peroxide Gel, 13 weeks
description: 13 weeks of twice-daily use of custom tray application of 1.7% peroxide gel as an adjunct to scaling and root planing in the treatment of chronic periodontitis.
arm group label: Hydrogen Peroxide gel for 13weeks
other name: Perio Protect®
other name: 1.7% hydrogen peroxide gel
intervention type: Drug
intervention name: Hydrogen Peroxide Gel, 26 weeks
description: 26 weeks of twice-daily use of custom tray application of 1.7% peroxide gel as an adjunct to scaling and root planing in the treatment of chronic periodontitis.
arm group label: Hydrogen Peroxide gel for 26weeks
other name: Perio Protect®
other name: 1.7% hydrogen peroxide gel
intervention type: Other
intervention name: Scaling and Root planing group
description: Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis without custom tray application of 1.7% peroxide gel
arm group label: Scaling and Root Planing
other name: SRP group control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yoon Jeong Kim, DDS
role: Principal Investigator
affiliation: Loma Linda University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Periodontitis
mesh term: Chronic Periodontitis
mesh term: Hydrogen Peroxide
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Due to COVID lockdown, the enrollment and study discontinued abruptly.
point of contact: 