<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/NCT03028727</url>
  </required_header>
  <id_info>
    <org_study_id>KLESocietyIDS</org_study_id>
    <nct_id>NCT03028727</nct_id>
  </id_info>
  <brief_title>Diode Laser Therapy As An Adjunct To Scaling And Root Planing</brief_title>
  <official_title>Diode Laser Therapy As An Adjunct To Non-Surgical Management Of Chronic Periodontitis - A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>KLE Society's Institute of Dental Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>KLE Society's Institute of Dental Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Laser therapy has been proposed as a novel treatment option in controlling subgingival&#xD;
      microorganisms. This randomized controlled clinical trial evaluates the effect of 980nm diode&#xD;
      laser as an adjunct to scaling and root planing (SRP) in the management of chronic&#xD;
      periodontitis (CP).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Conventional mechanical debridement can achieve a temporary decrease in the subgingival&#xD;
      levels of Pg along with other pathogens. However, mechanical therapy alone may fail to&#xD;
      eliminate pathogenic bacterial niches in inaccessible areas like deep pockets, root&#xD;
      concavities, furcation areas etc. In search of more efficient and less traumatic techniques&#xD;
      to improve periodontal healing, researchers proposed the use of lasers in periodontal&#xD;
      therapy.&#xD;
&#xD;
      The adjunctive use of lasers with conventional tools may facilitate treatment and have the&#xD;
      potential to improve healing. The diode laser is highly absorbed in hemoglobin and other&#xD;
      pigments and is excellent for use in soft tissue surgical procedures.Laser application in&#xD;
      improving clinical outcome in periodontal therapy, needs to be further investigated with well&#xD;
      designed clinical trials. The investigators attempted to evaluate the efficacy of diode laser&#xD;
      as an adjunct to SRP in the management of CP by evaluating clinical parameters coupled with&#xD;
      quantitative estimation of P.gingivalis using Real-time Polymerase chain reaction (RT-PCR)&#xD;
      assay.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2013</start_date>
  <completion_date type="Actual">September 2013</completion_date>
  <primary_completion_date type="Actual">September 2013</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in levels of P.gingivalis</measure>
    <time_frame>14 weeks</time_frame>
    <description>Microbial profile was assessed using PCR at baseline, 4-6 weeks and 12-14 weeks post treatment in both the study groups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in gingival index</measure>
    <time_frame>14 weeks</time_frame>
    <description>Gingival index by Loe and Silness was assessed at baseline, 4-6 weeks and 12-14 weeks post treatment in both the groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in plaque index</measure>
    <time_frame>14 weeks</time_frame>
    <description>Plaque index by Silness and Loe was assessed at baseline, 4-6 weeks and 12-14 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in probing pocket depth</measure>
    <time_frame>14 weeks</time_frame>
    <description>Probing pocket depth was assessed at baseline, 4-6 weeks and 12-14 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in clinical attachment level</measure>
    <time_frame>14 weeks</time_frame>
    <description>Clinical attachment level was assessed at baseline, 4-6 weeks and 12-14 weeks</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Chronic Periodontitis</condition>
  <arm_group>
    <arm_group_label>Ultrasonic Scaling, Root planing</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ultrasonic Scaling and Root planing at day 0 and at 1 week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>980 nm diode Laser irradiation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Irradiation of periodontal pockets with with 980 nm diode Laser after scaling and root planing at day 0 and after 1 week.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ultrasonic Scaling and root planing</intervention_name>
    <description>Procedure of scaling and root planing at day 0 and at 1 week</description>
    <arm_group_label>980 nm diode Laser irradiation</arm_group_label>
    <arm_group_label>Ultrasonic Scaling, Root planing</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>980 nm diode laser irradiation</intervention_name>
    <description>Procedure of scaling and root planing and application of 980 nm diode laser at day 0 and at 1 week</description>
    <arm_group_label>980 nm diode Laser irradiation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  40 systemically healthy subjects diagnosed with generalized moderate CP in the age&#xD;
             group of 30 to 50 years.&#xD;
&#xD;
          -  Minimum of 20 teeth having atleast two non-adjacent sites per quadrant with probing&#xD;
             pocket depth of ≥ 5mm and clinical attachment loss of 3- 4 mm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who had undergone periodontal therapy 6 months prior to the commencement of&#xD;
             the study.&#xD;
&#xD;
          -  Subjects on antibiotics or immunosuppressants.&#xD;
&#xD;
          -  Chronic smokers, alcoholics, smokeless tobacco users.&#xD;
&#xD;
          -  Subjects with acute illnesses/acute intraoral lesions.&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Subjects who had undergone extensive restorative dental treatment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 7, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>January 19, 2017</last_update_submitted>
  <last_update_submitted_qc>January 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>KLE Society's Institute of Dental Sciences</investigator_affiliation>
    <investigator_full_name>Veena H.R</investigator_full_name>
    <investigator_title>Reader, Department of Periodontics</investigator_title>
  </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>
  <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/NCT03028727
org study id: KLESocietyIDS
nct id: NCT03028727
lead sponsor: 
has dmc: Yes
Laser therapy has been proposed as a novel treatment option in controlling subgingival
      microorganisms. This randomized controlled clinical trial evaluates the effect of 980nm diode
      laser as an adjunct to scaling and root planing (SRP) in the management of chronic
      periodontitis (CP).
Conventional mechanical debridement can achieve a temporary decrease in the subgingival
      levels of Pg along with other pathogens. However, mechanical therapy alone may fail to
      eliminate pathogenic bacterial niches in inaccessible areas like deep pockets, root
      concavities, furcation areas etc. In search of more efficient and less traumatic techniques
      to improve periodontal healing, researchers proposed the use of lasers in periodontal
      therapy.

      The adjunctive use of lasers with conventional tools may facilitate treatment and have the
      potential to improve healing. The diode laser is highly absorbed in hemoglobin and other
      pigments and is excellent for use in soft tissue surgical procedures.Laser application in
      improving clinical outcome in periodontal therapy, needs to be further investigated with well
      designed clinical trials. The investigators attempted to evaluate the efficacy of diode laser
      as an adjunct to SRP in the management of CP by evaluating clinical parameters coupled with
      quantitative estimation of P.gingivalis using Real-time Polymerase chain reaction (RT-PCR)
      assay.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Change in levels of P.gingivalis
time frame: 14 weeks
description: Microbial profile was assessed using PCR at baseline, 4-6 weeks and 12-14 weeks post treatment in both the study groups.
measure: Change in gingival index
time frame: 14 weeks
description: Gingival index by Loe and Silness was assessed at baseline, 4-6 weeks and 12-14 weeks post treatment in both the groups
measure: Change in plaque index
time frame: 14 weeks
description: Plaque index by Silness and Loe was assessed at baseline, 4-6 weeks and 12-14 weeks
measure: Change in probing pocket depth
time frame: 14 weeks
description: Probing pocket depth was assessed at baseline, 4-6 weeks and 12-14 weeks
measure: Change in clinical attachment level
time frame: 14 weeks
description: Clinical attachment level was assessed at baseline, 4-6 weeks and 12-14 weeks
arm group label: Ultrasonic Scaling, Root planing
arm group type: Active Comparator
description: Ultrasonic Scaling and Root planing at day 0 and at 1 week.
arm group label: 980 nm diode Laser irradiation
arm group type: Experimental
description: Irradiation of periodontal pockets with with 980 nm diode Laser after scaling and root planing at day 0 and after 1 week.
intervention type: Procedure
intervention name: Ultrasonic Scaling and root planing
description: Procedure of scaling and root planing at day 0 and at 1 week
arm group label: 980 nm diode Laser irradiation
arm group label: Ultrasonic Scaling, Root planing
intervention type: Procedure
intervention name: 980 nm diode laser irradiation
description: Procedure of scaling and root planing and application of 980 nm diode laser at day 0 and at 1 week
arm group label: 980 nm diode Laser irradiation
criteria: 
gender: All
minimum age: 30 Years
maximum age: 50 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: KLE Society's Institute of Dental Sciences
investigator full name: Veena H.R
investigator title: Reader, Department of Periodontics
mesh term: Periodontitis
mesh term: Chronic Periodontitis
sharing ipd: No