<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/NCT03003689</url>
  </required_header>
  <id_info>
    <org_study_id>12321</org_study_id>
    <nct_id>NCT03003689</nct_id>
  </id_info>
  <brief_title>Effects of Scaling and Root Planing With and Without Er:YAG Laser in Chronic Periodontitis Patients</brief_title>
  <official_title>Randomized Clinical Trial Assessing the Clinical Outcomes and Recolonization Patterns Following Scaling and Root Planing With and Without Using Er.YAG Laser in Chronic Periodontitis Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tufts University School of Dental Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tufts University School of Dental Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Dental bacterial plaque is the most frequent modifiable finding in patients with periodontal&#xD;
      (gum) diseases. Many studies have provided evidence that mechanical removal of dental plaque&#xD;
      is critical for improving the periodontal health. The standard initial treatment of&#xD;
      periodontitis (gum disease) is to remove plaque and calculus form the teeth and root&#xD;
      structures using sclaing and root planing (SRP). Typically hand instruments and an ultrasonic&#xD;
      scaler are used for SRP&#xD;
&#xD;
      While this method removes some of the bacteria that leads to periodontitis, microorganisms&#xD;
      are not completely eliminated through SRP. Studies have shown that after 3 months, the&#xD;
      bacteria initially present prior to scaling and root planing had recolonized. In order to&#xD;
      prevent recurrence of periodontitis, it is recommended that oral bacteria be kept at low&#xD;
      levels.&#xD;
&#xD;
      When used at the proper wave length, dental lasers have been shown to effectively removes&#xD;
      calculus, without damaging surrounding tissue. The Er:YAG laser has been FDA-approved for the&#xD;
      use of scaling and root planing in Dentistry. While studies on the Er:YAG laser have shown&#xD;
      that it is effective in removing calculus and preserving the tooth root structure, there is&#xD;
      no consensus of the level of calculus removal. The Er:YAG laser may also be more effective in&#xD;
      removing microbial bacteria than SRP with hand instruments and ultrasonic scaler.&#xD;
&#xD;
      The purpose of this study is to evaluate the effectiveness of the Er:YAG laser, as an adjunct&#xD;
      to scaling and root planing, in removing microbial bacteria. Participants with chronic&#xD;
      periodontitis will be randomized to have one quadrant undergo scaling and root planing using&#xD;
      hand instruments and ultrasonic scaler alone, while a second quadrant will receive the same&#xD;
      treatment, with the addition of the Er:YAG laser. Outcomes studies will be traditional&#xD;
      periodontal clinical parameters at 6 weeks and 3 months after treatment. Microbial cultures&#xD;
      will be performed at baseline and 3 months to compare survival and re-population by&#xD;
      periodontal microorganisms.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary Aim: The primary aim of this study is to evaluate the efficacy of Er:YAG laser as an&#xD;
      adjunct to mechanical scaling and root planing periodontal therapy by comparing probing depth&#xD;
      and clinical attachment levels.&#xD;
&#xD;
      Secondary aim: The secondary aim of this study is to evaluate the efficacy of Er:YAG laser as&#xD;
      an adjunct to mechanical scaling and root planing periodontal therapy by comparing gingival&#xD;
      bleeding index and plaque index.&#xD;
&#xD;
      Tertiary aim: The tertiary aim of this study is to compare the microbial outcomes of&#xD;
      mechanical periodontal therapy alone vs. mechanical therapy combined followed with Er:YAG&#xD;
      laser therapy at the same time.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 20, 2017</start_date>
  <completion_date type="Anticipated">March 2018</completion_date>
  <primary_completion_date type="Anticipated">March 2018</primary_completion_date>
  <phase>N/A</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>Change in Probing Depth</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>Differences in pocket depth reduction between laser treatment and control groups will be analyzed with a linear mixed effects model. Four sites (mesiolingual, mesiobuccal, distolingual, and distobuccal) per tooth will be averaged and used in the linear mixed effects model. Normality of the data will be assessed graphically and with the Shapiro-Wilk test.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Clinical Attachment Levels</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>Differences in attachment gain between laser treatment and control groups will be analyzed with a linear mixed effects model. Four sites (mesiolingual, mesiobuccal, distolingual, and distobuccal) per tooth will be averaged and used in the linear mixed effects model. Normality of the data will be assessed graphically and with the Shapiro-Wilk test.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Gingival Bleeding Index</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>The gingival bleeding index (the number of bleeding sites divided by the total number of sites) will be calculated. Statistical significance between the two groups' gingival bleeding index will be determined with generalized estimating equations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Plaque Index</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>The plaque index (the number of surfaces with plaque divided by the total number of surfaces) will be calculated. Statistical significance between the two groups' plaque index will be determined with generalized estimating equations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in microbial load, measured in Colony Forming Units (CFUs)</measure>
    <time_frame>baseline, 3 months</time_frame>
    <description>Microbial load will be measured by the total number of cultivable bacteria measured by total viable colony forming units (CFUs) on non-selective and selective media. Percent cultivability of periodontal pathogens will be measured by number of pathogen specific CFUs in proportion to total cultivability.&#xD;
Differences in microbial load will be investigated with the paired t-test. If the assumption of normality is unmet, the Wilcoxon rank-sum test will be used instead.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">56</enrollment>
  <condition>Chronic Periodontitis</condition>
  <arm_group>
    <arm_group_label>Scaling and Root Planing</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Hand instruments + ultrasonic scaler&#xD;
PD, CAL, plaque index and gingival bleeding index will be measured at baseline, 6 weeks and 3 months. Microbial load will be measured at baseline and 3 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Scaling and Root Planing + Er:YAG Laser</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Er:YAG Laser, hand instruments + ultrasonic scaler&#xD;
PD, CAL, plaque index and gingival bleeding index will be measured at baseline, 6 weeks and 3 months. Microbial load will be measured at baseline and 3 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Scaling and Root Planing</intervention_name>
    <description>Standard of care scaling and root planing using hand instruments and ultrasonic scaler</description>
    <arm_group_label>Scaling and Root Planing</arm_group_label>
    <arm_group_label>Scaling and Root Planing + Er:YAG Laser</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Er:YAG Laser</intervention_name>
    <description>Er:YAG laser as an adjunct therapy to standard of care scaling and root planing using hand instruments and ultrasonic</description>
    <arm_group_label>Scaling and Root Planing + Er:YAG Laser</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients enrolled in the Post-Graduate Periodontology Clinic at Tufts University&#xD;
             School of Dental Medicine (TUSDM)&#xD;
&#xD;
          -  Recent (within the past 30 days) diagnosis of moderate to severe chronic periodontitis&#xD;
             in at least two quadrants according to the Armitage Classification&#xD;
&#xD;
          -  Have had full mouth and vertical bite-wing series of diagnostic radiographs exposed at&#xD;
             TUSDM within 6 months preceding entry of the study as a standard of care&#xD;
&#xD;
          -  Have a treatment plan made by the original provider and certified by the PI based on&#xD;
             the working diagnosis, presenting etiology, and the predicted therapeutic outcomes of&#xD;
             the case (prognosis).&#xD;
&#xD;
          -  Each of the two selected quadrants should have at least 5 teeth including the canine,&#xD;
             first premolar and second premolar in contact with at least one tooth that has ≥ 5 mms&#xD;
             and ≤ 9 mms probing depths with bleeding on probing.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants must not have had mechanical debridement or any other professional&#xD;
             periodontal therapy within 6 months preceding entering the study&#xD;
&#xD;
          -  Participants with significant chronic oral soft tissue pathology (lichen planus,&#xD;
             Benign Mucous Membrane Pemphigoid, Steven Johnson's Syndrome, Sjogren's Syndrome,&#xD;
             etc.) which might affect host response to the presence of bacteria.&#xD;
&#xD;
          -  Participants with fixed appliances or partial dentures, to standardize the effect of&#xD;
             the treatment since they are plaque retentive.&#xD;
&#xD;
          -  Participants who smoke tobacco&#xD;
&#xD;
          -  Participants who require prophylactic antibiotics prior to dental treatment&#xD;
&#xD;
          -  Participants who have taken systemic antibiotic medications within the previous 6&#xD;
             months&#xD;
&#xD;
          -  Participants with uncontrolled systemic conditions or disease such as diabetes and&#xD;
             immunological disorders&#xD;
&#xD;
          -  Participants with known drug allergies or known adverse effects following the use of&#xD;
             oral hygiene products.&#xD;
&#xD;
          -  Participants who are pregnant or lactating&#xD;
&#xD;
          -  Teeth with grade III mobility or teeth with hopeless prognosis indicated for&#xD;
             extraction&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Charles Hawley, DDS, MS, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>TUSDM</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Amanda Program Manager</last_name>
    <phone>614-636-2147</phone>
    <email>dentalresearchadministration@tufts.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Tufts University School of Dental Medicine</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02111</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Charles Hawley, DDS, MS, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>December 9, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 28, 2016</study_first_posted>
  <last_update_submitted>January 9, 2018</last_update_submitted>
  <last_update_submitted_qc>January 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Scaling and Root Planing</keyword>
  <keyword>Er:YAG</keyword>
  <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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03003689
org study id: 12321
nct id: NCT03003689
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
Dental bacterial plaque is the most frequent modifiable finding in patients with periodontal
      (gum) diseases. Many studies have provided evidence that mechanical removal of dental plaque
      is critical for improving the periodontal health. The standard initial treatment of
      periodontitis (gum disease) is to remove plaque and calculus form the teeth and root
      structures using sclaing and root planing (SRP). Typically hand instruments and an ultrasonic
      scaler are used for SRP

      While this method removes some of the bacteria that leads to periodontitis, microorganisms
      are not completely eliminated through SRP. Studies have shown that after 3 months, the
      bacteria initially present prior to scaling and root planing had recolonized. In order to
      prevent recurrence of periodontitis, it is recommended that oral bacteria be kept at low
      levels.

      When used at the proper wave length, dental lasers have been shown to effectively removes
      calculus, without damaging surrounding tissue. The Er:YAG laser has been FDA-approved for the
      use of scaling and root planing in Dentistry. While studies on the Er:YAG laser have shown
      that it is effective in removing calculus and preserving the tooth root structure, there is
      no consensus of the level of calculus removal. The Er:YAG laser may also be more effective in
      removing microbial bacteria than SRP with hand instruments and ultrasonic scaler.

      The purpose of this study is to evaluate the effectiveness of the Er:YAG laser, as an adjunct
      to scaling and root planing, in removing microbial bacteria. Participants with chronic
      periodontitis will be randomized to have one quadrant undergo scaling and root planing using
      hand instruments and ultrasonic scaler alone, while a second quadrant will receive the same
      treatment, with the addition of the Er:YAG laser. Outcomes studies will be traditional
      periodontal clinical parameters at 6 weeks and 3 months after treatment. Microbial cultures
      will be performed at baseline and 3 months to compare survival and re-population by
      periodontal microorganisms.
Primary Aim: The primary aim of this study is to evaluate the efficacy of Er:YAG laser as an
      adjunct to mechanical scaling and root planing periodontal therapy by comparing probing depth
      and clinical attachment levels.

      Secondary aim: The secondary aim of this study is to evaluate the efficacy of Er:YAG laser as
      an adjunct to mechanical scaling and root planing periodontal therapy by comparing gingival
      bleeding index and plaque index.

      Tertiary aim: The tertiary aim of this study is to compare the microbial outcomes of
      mechanical periodontal therapy alone vs. mechanical therapy combined followed with Er:YAG
      laser therapy at the same time.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in Probing Depth
time frame: Up to 3 months
description: Differences in pocket depth reduction between laser treatment and control groups will be analyzed with a linear mixed effects model. Four sites (mesiolingual, mesiobuccal, distolingual, and distobuccal) per tooth will be averaged and used in the linear mixed effects model. Normality of the data will be assessed graphically and with the Shapiro-Wilk test.
measure: Change in Clinical Attachment Levels
time frame: Up to 3 months
description: Differences in attachment gain between laser treatment and control groups will be analyzed with a linear mixed effects model. Four sites (mesiolingual, mesiobuccal, distolingual, and distobuccal) per tooth will be averaged and used in the linear mixed effects model. Normality of the data will be assessed graphically and with the Shapiro-Wilk test.
measure: Change in Gingival Bleeding Index
time frame: Up to 3 months
description: The gingival bleeding index (the number of bleeding sites divided by the total number of sites) will be calculated. Statistical significance between the two groups' gingival bleeding index will be determined with generalized estimating equations.
measure: Change in Plaque Index
time frame: Up to 3 months
description: The plaque index (the number of surfaces with plaque divided by the total number of surfaces) will be calculated. Statistical significance between the two groups' plaque index will be determined with generalized estimating equations.
measure: Change in microbial load, measured in Colony Forming Units (CFUs)
time frame: baseline, 3 months
description: Microbial load will be measured by the total number of cultivable bacteria measured by total viable colony forming units (CFUs) on non-selective and selective media. Percent cultivability of periodontal pathogens will be measured by number of pathogen specific CFUs in proportion to total cultivability.
Differences in microbial load will be investigated with the paired t-test. If the assumption of normality is unmet, the Wilcoxon rank-sum test will be used instead.
arm group label: Scaling and Root Planing
arm group type: Active Comparator
description: Hand instruments + ultrasonic scaler
PD, CAL, plaque index and gingival bleeding index will be measured at baseline, 6 weeks and 3 months. Microbial load will be measured at baseline and 3 months.
arm group label: Scaling and Root Planing + Er:YAG Laser
arm group type: Experimental
description: Er:YAG Laser, hand instruments + ultrasonic scaler
PD, CAL, plaque index and gingival bleeding index will be measured at baseline, 6 weeks and 3 months. Microbial load will be measured at baseline and 3 months.
intervention type: Procedure
intervention name: Scaling and Root Planing
description: Standard of care scaling and root planing using hand instruments and ultrasonic scaler
arm group label: Scaling and Root Planing
arm group label: Scaling and Root Planing + Er:YAG Laser
intervention type: Device
intervention name: Er:YAG Laser
description: Er:YAG laser as an adjunct therapy to standard of care scaling and root planing using hand instruments and ultrasonic
arm group label: Scaling and Root Planing + Er:YAG Laser
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Charles Hawley, DDS, MS, PhD
role: Principal Investigator
affiliation: TUSDM
last name: Amanda Program Manager
phone: 614-636-2147
email: dentalresearchadministration@tufts.edu
facility: 
status: Recruiting
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Periodontitis
mesh term: Chronic Periodontitis
sharing ipd: No