<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/NCT03754010</url>
  </required_header>
  <id_info>
    <org_study_id>19.07.2017/09</org_study_id>
    <nct_id>NCT03754010</nct_id>
  </id_info>
  <brief_title>Does Hyaluronic Acid Affect Periodontal Treatment?</brief_title>
  <official_title>Evaluation of Clinical and Biochemical Effects of Hyaluronic Acid on Periodontitis: A Split-mouth Randomized-controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yuzuncu Yıl University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yuzuncu Yıl University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objective: The aim of this study is to evaluate the effect of HA as an adjunct to scaling and&#xD;
      root planning (SRP) on clinical parameters, periodontal inflamed surface area (PISA) and&#xD;
      adenosine deaminase (ADA), catalase (CAT), and glutathione (GSH) levels in gingival&#xD;
      crevicular fluid (GCF) in patients with periodontitis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Design: A total of 24 Stage II-III periodontitis patients will be included in this&#xD;
      split-mouth, randomized-controlled study. The study population will be divided into four&#xD;
      groups: in Group 1 (SRP): SRP+ saline; in Group 2 (SRP+HAgel): SRP + HA gel; in Group 3&#xD;
      (SRP+HAmo): SRP+ HA mouthrinse; and in Group 4 (SRP+HAmo+HAgel): SRP+HA mouthrinse + HA&#xD;
      gingival gel were applied. At baseline and Week 4 periodontal clinical parameters and PISA&#xD;
      will be calculated. Also, GCF amount will be collected to evaluate ADA, CAT, and GSH by&#xD;
      spectrophotometric analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 30, 2017</start_date>
  <completion_date type="Actual">September 30, 2018</completion_date>
  <primary_completion_date type="Actual">April 30, 2018</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>plaque index</measure>
    <time_frame>Change from Baseline to week 4</time_frame>
    <description>in accordance with the Sillness and Löe index (Silness &amp; Löe, 1964)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>gingival index (GI)</measure>
    <time_frame>Change from Baseline to week 4</time_frame>
    <description>confirming to Silness and Löe index (Löe &amp; Silness, 1963)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>bleeding on probing (BOP)</measure>
    <time_frame>Change from Baseline to week 4</time_frame>
    <description>according to Ainoma and Bay (AINAMO &amp; Bay, 1975);</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Probing depth (PD)</measure>
    <time_frame>Change from Baseline to week 4</time_frame>
    <description>as the measurement of the length between the bottom of the periodontal pocket to marginal gingiva;</description>
  </primary_outcome>
  <primary_outcome>
    <measure>gingival recession height (GRH)</measure>
    <time_frame>Change from Baseline to week 4</time_frame>
    <description>as the measurement of the distance between the marginal gingiva and cemento-enamel junction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>clinical attachment level (CAL)</measure>
    <time_frame>Change from Baseline to week 4</time_frame>
    <description>as the sum of gingival recession height and probing depth will be recorded.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes of Periodontal inflammed surface area</measure>
    <time_frame>Change from Baseline Baseline to week 4</time_frame>
    <description>All clinical parameters will be entered on Microsoft Excel Program (www.parsprototo.info) which constructed for calculating PISA. The BOP percentage for each tooth will be calculated by entering &quot;number sites with BOP&quot; values in the Excel program.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of Adenosine deaminase (ADA) levels in gingival crevicular fluid</measure>
    <time_frame>Changes from Baseline to week 1,2,4</time_frame>
    <description>The ADA activity will be evaluated spectrophotometrically</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of Catalase levels in gingival crevicular fluid</measure>
    <time_frame>Changes from Baseline to week 1,2,4</time_frame>
    <description>The catalase activity will be evaluated spectrophotometrically</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of Glutathione levels in gingival crevicular fluid</measure>
    <time_frame>Changes from Baseline to week 1,2,4</time_frame>
    <description>The Glutathione activity will be evaluated spectrophotometrically</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Periodontitis</condition>
  <arm_group>
    <arm_group_label>Scaling and root planning (SRP)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Under local anesthesia, full-mouth SRP was performed within 24 h in a single or two sessions using ultrasonic and hand instruments (Gracey, Hu-Friedy, Chicago, IL, USA) by a single investigator (DA). Immediately after the SRP, HA gel (Gengigel, Hyaluronic acid, gingival gel, Ricefarma S.R.L, Italy) or mouthrinse was performed according to the groups' procedure. In Group 1, the periodontal sulcus was irrigated with saline solution after SRP.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hyaluronic acid gel (HA) and SRP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group 2, after SRP was performed and irrigated with saline the area was dried with a soft air and, then, a gel containing HA was applied intrasulcular.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HA mouthrinse and SRP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In Group 3, HA hydrogel mouthrinse (Gengigel, Hyaluronic acid, Hydrogel moutrinse for gums, Ricefarma S.R.L, Italy) were used as an irrigator after SRP.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HA mouthrinse+gel and SRP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In Group 4, after SRP was performed, the sulcus was irrigated with HA hydrogel mouthrinse and, then, intrasulculary HA gingival gel was applied.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Scaling and root planning</intervention_name>
    <description>Under local anesthesia, full-mouth SRP will be performed by a single investigator. Immediately after the SRP, HA gel or mouthrinse will perform according to the groups' procedure. In Group 1, the periodontal sulcus will be irrigated with saline solution after SRP.</description>
    <arm_group_label>HA mouthrinse and SRP</arm_group_label>
    <arm_group_label>HA mouthrinse+gel and SRP</arm_group_label>
    <arm_group_label>Hyaluronic acid gel (HA) and SRP</arm_group_label>
    <arm_group_label>Scaling and root planning (SRP)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hyaluronic acid gel (HA) and SRP</intervention_name>
    <description>In Group 2, after SRP will be performed and irrigated with saline the area was dried with a soft air and, then, a gel containing HA will be applied intrasulcular.</description>
    <arm_group_label>Hyaluronic acid gel (HA) and SRP</arm_group_label>
    <other_name>HA and SRP</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>HA mouthrinse and SRP</intervention_name>
    <description>In Group 3, HA hydrogel mouthrinse will be used as an irrigator after SRP.</description>
    <arm_group_label>HA mouthrinse and SRP</arm_group_label>
    <other_name>HAmo+SRP</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>HA mouthrinse+gel and SRP</intervention_name>
    <description>In Group 4, after SRP will be performed, the sulcus was irrigated with HA hydrogel mouthrinse and, then, intrasulculary HA gingival gel will be applied.</description>
    <arm_group_label>HA mouthrinse+gel and SRP</arm_group_label>
    <other_name>HAmo+HAgel+SRP</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Systemically healthy&#xD;
&#xD;
          -  moderate-to-severe periodontitis&#xD;
&#xD;
          -  at least five sites with ≥5mm probing depth (PD)&#xD;
&#xD;
          -  at least ≥20 teeth&#xD;
&#xD;
          -  Stage II-III periodontitis according to the 2017 World Workshop&#xD;
&#xD;
          -  Age between18-55&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  receiving systemic or local antibiotics within the past six months&#xD;
&#xD;
          -  prior surgical or non-surgical periodontal treatment within the past six months&#xD;
&#xD;
          -  smoking&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  lactation&#xD;
&#xD;
          -  age ≤18 years or ≥55 years&#xD;
&#xD;
          -  hypertension&#xD;
&#xD;
          -  known chronic systemic diseases (i.e., diabetes mellitus, rheumatoid arthritis), - -&#xD;
             known hypersensitivity to one of the ingredients of the HA preparation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hacer Sahin Aydinyurt, Assist Prof</last_name>
    <role>Study Director</role>
    <affiliation>Van Yuzuncu Yil University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Van Yuzuncu Yil University Faculty of Dentistry</name>
      <address>
        <city>VAN</city>
        <zip>65080</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 15, 2018</study_first_submitted>
  <study_first_submitted_qc>November 23, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>November 23, 2018</last_update_submitted>
  <last_update_submitted_qc>November 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Yuzuncu Yıl University</investigator_affiliation>
    <investigator_full_name>Hacer Sahin Aydinyurt</investigator_full_name>
    <investigator_title>Assist Prof</investigator_title>
  </responsible_party>
  <keyword>periodontitis</keyword>
  <keyword>hyaluronic acid</keyword>
  <keyword>scaling and root planning</keyword>
  <keyword>adenosione deaminase</keyword>
  <keyword>catalase</keyword>
  <keyword>glutathione</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periodontitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyaluronic Acid</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03754010
org study id: 19.07.2017/09
nct id: NCT03754010
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Objective: The aim of this study is to evaluate the effect of HA as an adjunct to scaling and
      root planning (SRP) on clinical parameters, periodontal inflamed surface area (PISA) and
      adenosine deaminase (ADA), catalase (CAT), and glutathione (GSH) levels in gingival
      crevicular fluid (GCF) in patients with periodontitis.
Design: A total of 24 Stage II-III periodontitis patients will be included in this
      split-mouth, randomized-controlled study. The study population will be divided into four
      groups: in Group 1 (SRP): SRP+ saline; in Group 2 (SRP+HAgel): SRP + HA gel; in Group 3
      (SRP+HAmo): SRP+ HA mouthrinse; and in Group 4 (SRP+HAmo+HAgel): SRP+HA mouthrinse + HA
      gingival gel were applied. At baseline and Week 4 periodontal clinical parameters and PISA
      will be calculated. Also, GCF amount will be collected to evaluate ADA, CAT, and GSH by
      spectrophotometric analysis.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: plaque index
time frame: Change from Baseline to week 4
description: in accordance with the Sillness and Löe index (Silness & Löe, 1964)
measure: gingival index (GI)
time frame: Change from Baseline to week 4
description: confirming to Silness and Löe index (Löe & Silness, 1963)
measure: bleeding on probing (BOP)
time frame: Change from Baseline to week 4
description: according to Ainoma and Bay (AINAMO & Bay, 1975);
measure: Probing depth (PD)
time frame: Change from Baseline to week 4
description: as the measurement of the length between the bottom of the periodontal pocket to marginal gingiva;
measure: gingival recession height (GRH)
time frame: Change from Baseline to week 4
description: as the measurement of the distance between the marginal gingiva and cemento-enamel junction
measure: clinical attachment level (CAL)
time frame: Change from Baseline to week 4
description: as the sum of gingival recession height and probing depth will be recorded.
measure: Changes of Periodontal inflammed surface area
time frame: Change from Baseline Baseline to week 4
description: All clinical parameters will be entered on Microsoft Excel Program (www.parsprototo.info) which constructed for calculating PISA. The BOP percentage for each tooth will be calculated by entering "number sites with BOP" values in the Excel program.
measure: Changes of Adenosine deaminase (ADA) levels in gingival crevicular fluid
time frame: Changes from Baseline to week 1,2,4
description: The ADA activity will be evaluated spectrophotometrically
measure: Changes of Catalase levels in gingival crevicular fluid
time frame: Changes from Baseline to week 1,2,4
description: The catalase activity will be evaluated spectrophotometrically
measure: Changes of Glutathione levels in gingival crevicular fluid
time frame: Changes from Baseline to week 1,2,4
description: The Glutathione activity will be evaluated spectrophotometrically
arm group label: Scaling and root planning (SRP)
arm group type: Placebo Comparator
description: Under local anesthesia, full-mouth SRP was performed within 24 h in a single or two sessions using ultrasonic and hand instruments (Gracey, Hu-Friedy, Chicago, IL, USA) by a single investigator (DA). Immediately after the SRP, HA gel (Gengigel, Hyaluronic acid, gingival gel, Ricefarma S.R.L, Italy) or mouthrinse was performed according to the groups' procedure. In Group 1, the periodontal sulcus was irrigated with saline solution after SRP.
arm group label: Hyaluronic acid gel (HA) and SRP
arm group type: Experimental
description: Group 2, after SRP was performed and irrigated with saline the area was dried with a soft air and, then, a gel containing HA was applied intrasulcular.
arm group label: HA mouthrinse and SRP
arm group type: Experimental
description: In Group 3, HA hydrogel mouthrinse (Gengigel, Hyaluronic acid, Hydrogel moutrinse for gums, Ricefarma S.R.L, Italy) were used as an irrigator after SRP.
arm group label: HA mouthrinse+gel and SRP
arm group type: Experimental
description: In Group 4, after SRP was performed, the sulcus was irrigated with HA hydrogel mouthrinse and, then, intrasulculary HA gingival gel was applied.
intervention type: Procedure
intervention name: Scaling and root planning
description: Under local anesthesia, full-mouth SRP will be performed by a single investigator. Immediately after the SRP, HA gel or mouthrinse will perform according to the groups' procedure. In Group 1, the periodontal sulcus will be irrigated with saline solution after SRP.
arm group label: HA mouthrinse and SRP
arm group label: HA mouthrinse+gel and SRP
arm group label: Hyaluronic acid gel (HA) and SRP
arm group label: Scaling and root planning (SRP)
intervention type: Drug
intervention name: Hyaluronic acid gel (HA) and SRP
description: In Group 2, after SRP will be performed and irrigated with saline the area was dried with a soft air and, then, a gel containing HA will be applied intrasulcular.
arm group label: Hyaluronic acid gel (HA) and SRP
other name: HA and SRP
intervention type: Drug
intervention name: HA mouthrinse and SRP
description: In Group 3, HA hydrogel mouthrinse will be used as an irrigator after SRP.
arm group label: HA mouthrinse and SRP
other name: HAmo+SRP
intervention type: Drug
intervention name: HA mouthrinse+gel and SRP
description: In Group 4, after SRP will be performed, the sulcus was irrigated with HA hydrogel mouthrinse and, then, intrasulculary HA gingival gel will be applied.
arm group label: HA mouthrinse+gel and SRP
other name: HAmo+HAgel+SRP
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: Hacer Sahin Aydinyurt, Assist Prof
role: Study Director
affiliation: Van Yuzuncu Yil University
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Yuzuncu Yıl University
investigator full name: Hacer Sahin Aydinyurt
investigator title: Assist Prof
mesh term: Periodontitis
mesh term: Hyaluronic Acid