<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/NCT03023995</url>
  </required_header>
  <id_info>
    <org_study_id>DYP/2010/2PE</org_study_id>
    <nct_id>NCT03023995</nct_id>
  </id_info>
  <brief_title>Coronally Advanced Flap With Connective Tissue Graft and PRF for Recession Coverage</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dr. D. Y. Patil Dental College &amp; Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dr. D. Y. Patil Dental College &amp; Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Over the years, numerous surgical techniques such as free autografts and pedicle grafts have&#xD;
      been introduced to correct gingival recession defects. Combination grafts with either&#xD;
      autografts or allografts, and newer concepts of guided tissue regeneration (GTR), platelet&#xD;
      concentrates, etc., were developed more recently to correct mucogingival defects. The use of&#xD;
      PRF in various surgical procedures such as degree II furcations, intrabony defects, sinus&#xD;
      floor segmentation during implant placement and on facial plastic surgeries have shown&#xD;
      promising results. However to our knowledge, till this study was completed, no studies have&#xD;
      been reported with the clinical outcomes of autologous platelet rich fibrin membrane for the&#xD;
      treatment of localized gingival recession defects.&#xD;
&#xD;
      Hence, this study was designed to compare coronally advanced flap with platelet rich fibrin&#xD;
      membrane versus subepithelial connective tissue graft in treatment of Miller's Class I and&#xD;
      Class II gingival recession defects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study design consist of twenty sites from ten patients were randomly selected by tossing&#xD;
      the coin for the study, which are divided into test group( Root coverage was performed by&#xD;
      coronally advanced flap with platelet rich fibrin membrane) and Control group (Root coverage&#xD;
      was performed with coronal advanced flap with subepithelial connective tissue graft.)&#xD;
&#xD;
      The Surgical Procedure consist of i) Preparation of the recipient bed: After adequate&#xD;
      anesthesia, trapezoidal flap was designed using three incisions which is followed by&#xD;
      reflection of partial thickness flap was raised apical to the crest of the osseous&#xD;
      dehiscence. A periosteal releasing incision was given to enable the coronal advancement of&#xD;
      the flap. Following this, root planing was done and the mesial and distal interdental&#xD;
      papillae were deepithelialized.&#xD;
&#xD;
      The exposed root surface was conditioned with tetracycline hydrochloride for four mins. (The&#xD;
      tetracycline hydrochloride powder was mixed with saline in dappen dish and then applied on&#xD;
      the root surface).&#xD;
&#xD;
      In test group, preparation of PRF was carried out, after which the flap was coronally&#xD;
      positioned over the membrane to completely cover it and secured with non resorbable sutures.&#xD;
      The surgical area was covered with a non - eugenol periodontal dressing with post-operative&#xD;
      antibiotics and analgesics and post-operative instructions that were given to all the&#xD;
      patients.&#xD;
&#xD;
      In control group, connective tissue graft harvesting was carried out which was followed by&#xD;
      placement of connective tissue graft on the recipient site. The connective tissue graft was&#xD;
      placed on the recipient site and secured in position with vicryl sutures. The flap was&#xD;
      coronally positioned over the connective tissue graft and secured with non resorbable&#xD;
      sutures. The recipient bed was covered with a non-eugenol periodontal dressing with&#xD;
      post-operative antibiotics and analgesics and post- operative instructions that were given to&#xD;
      all the patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2015</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">August 2016</primary_completion_date>
  <phase>Phase 3</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, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reduction in recession depth</measure>
    <time_frame>Baseline to 6 months</time_frame>
    <description>Recession depth reduction from baseline to 6 months</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reduction in Mean plaque scores</measure>
    <time_frame>baseline to 6 months</time_frame>
    <description>Mean plaque score reduction form baseline to 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduction in mean gingival scores</measure>
    <time_frame>Baseline to 6 months</time_frame>
    <description>Mean gingival score reduction from baseline to 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Width of keratinised tissue</measure>
    <time_frame>baseline to 6 months</time_frame>
    <description>Mean keratinised tissue increase from baseline to 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change Relative attachment level</measure>
    <time_frame>baseline to 6 months</time_frame>
    <description>Gain in relative attachment level from baseline to 6 months</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Gingival Recession</condition>
  <arm_group>
    <arm_group_label>CAF with Platelet Rich Fibrin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In test group, preparation of PRF was carried out, after which the flap was coronally positioned over the membrane to completely cover it.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CAF with connective tissue graft</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In control group, connective tissue graft harvesting was carried out which was followed by placement of connective tissue graft on the recipient site. The connective tissue graft was placed on the recipient site and secured in position with 5-0 vicryl sutures</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>CAF with Platelet rich fibrin</intervention_name>
    <description>In test group, preparation of PRF was carried out, after which the flap was coronally positioned over the membrane to completely cover it and secured with 4-0 non resorbable sutures.</description>
    <arm_group_label>CAF with Platelet Rich Fibrin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>CAF with connective tissue graft</intervention_name>
    <description>In control group, connective tissue graft was harvested, after which the flap was coronally positioned over the graft to completely cover it and secured with 4-0 non resorbable.</description>
    <arm_group_label>CAF with connective tissue graft</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female patients with age group between 20 to 55 years,&#xD;
&#xD;
          -  Presence of bilateral Millers Class I or II gingival recession defects,&#xD;
&#xD;
          -  Periodontally healthy patients,&#xD;
&#xD;
          -  Patient who demonstrate acceptable oral hygiene status prior to surgical procedure,&#xD;
&#xD;
          -  Patient with a medium to deep palatal vault (for Control Group only),&#xD;
&#xD;
          -  Patients agreed to give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of prolonged use of antibiotics / steroids /immunosuppressive&#xD;
             agents/aspirin/anticoagulants/other medications,&#xD;
&#xD;
          -  Pregnant women,&#xD;
&#xD;
          -  Smokers,&#xD;
&#xD;
          -  History of systemic diseases like hypertension, diabetes, HIV, bone metabolic&#xD;
             disorders, radiation therapy, immunosuppressive therapy, cancer, etc.&#xD;
&#xD;
          -  Patients with unacceptable oral hygiene,&#xD;
&#xD;
          -  Faulty tooth brushing technique,&#xD;
&#xD;
          -  Mal-aligned tooth,&#xD;
&#xD;
          -  Cervical abrasion,&#xD;
&#xD;
          -  Teeth with prominent roots.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>January 13, 2017</last_update_submitted>
  <last_update_submitted_qc>January 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dr. D. Y. Patil Dental College &amp; Hospital</investigator_affiliation>
    <investigator_full_name>Santosh Martande</investigator_full_name>
    <investigator_title>Lecturer</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gingival Recession</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/NCT03023995
org study id: DYP/2010/2PE
nct id: NCT03023995
lead sponsor: 
has dmc: No
Over the years, numerous surgical techniques such as free autografts and pedicle grafts have
      been introduced to correct gingival recession defects. Combination grafts with either
      autografts or allografts, and newer concepts of guided tissue regeneration (GTR), platelet
      concentrates, etc., were developed more recently to correct mucogingival defects. The use of
      PRF in various surgical procedures such as degree II furcations, intrabony defects, sinus
      floor segmentation during implant placement and on facial plastic surgeries have shown
      promising results. However to our knowledge, till this study was completed, no studies have
      been reported with the clinical outcomes of autologous platelet rich fibrin membrane for the
      treatment of localized gingival recession defects.

      Hence, this study was designed to compare coronally advanced flap with platelet rich fibrin
      membrane versus subepithelial connective tissue graft in treatment of Miller's Class I and
      Class II gingival recession defects.
The study design consist of twenty sites from ten patients were randomly selected by tossing
      the coin for the study, which are divided into test group( Root coverage was performed by
      coronally advanced flap with platelet rich fibrin membrane) and Control group (Root coverage
      was performed with coronal advanced flap with subepithelial connective tissue graft.)

      The Surgical Procedure consist of i) Preparation of the recipient bed: After adequate
      anesthesia, trapezoidal flap was designed using three incisions which is followed by
      reflection of partial thickness flap was raised apical to the crest of the osseous
      dehiscence. A periosteal releasing incision was given to enable the coronal advancement of
      the flap. Following this, root planing was done and the mesial and distal interdental
      papillae were deepithelialized.

      The exposed root surface was conditioned with tetracycline hydrochloride for four mins. (The
      tetracycline hydrochloride powder was mixed with saline in dappen dish and then applied on
      the root surface).

      In test group, preparation of PRF was carried out, after which the flap was coronally
      positioned over the membrane to completely cover it and secured with non resorbable sutures.
      The surgical area was covered with a non - eugenol periodontal dressing with post-operative
      antibiotics and analgesics and post-operative instructions that were given to all the
      patients.

      In control group, connective tissue graft harvesting was carried out which was followed by
      placement of connective tissue graft on the recipient site. The connective tissue graft was
      placed on the recipient site and secured in position with vicryl sutures. The flap was
      coronally positioned over the connective tissue graft and secured with non resorbable
      sutures. The recipient bed was covered with a non-eugenol periodontal dressing with
      post-operative antibiotics and analgesics and post- operative instructions that were given to
      all the patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Reduction in recession depth
time frame: Baseline to 6 months
description: Recession depth reduction from baseline to 6 months
measure: Reduction in Mean plaque scores
time frame: baseline to 6 months
description: Mean plaque score reduction form baseline to 6 months
measure: Reduction in mean gingival scores
time frame: Baseline to 6 months
description: Mean gingival score reduction from baseline to 6 months
measure: Width of keratinised tissue
time frame: baseline to 6 months
description: Mean keratinised tissue increase from baseline to 6 months
measure: Change Relative attachment level
time frame: baseline to 6 months
description: Gain in relative attachment level from baseline to 6 months
arm group label: CAF with Platelet Rich Fibrin
arm group type: Experimental
description: In test group, preparation of PRF was carried out, after which the flap was coronally positioned over the membrane to completely cover it.
arm group label: CAF with connective tissue graft
arm group type: Active Comparator
description: In control group, connective tissue graft harvesting was carried out which was followed by placement of connective tissue graft on the recipient site. The connective tissue graft was placed on the recipient site and secured in position with 5-0 vicryl sutures
intervention type: Procedure
intervention name: CAF with Platelet rich fibrin
description: In test group, preparation of PRF was carried out, after which the flap was coronally positioned over the membrane to completely cover it and secured with 4-0 non resorbable sutures.
arm group label: CAF with Platelet Rich Fibrin
intervention type: Procedure
intervention name: CAF with connective tissue graft
description: In control group, connective tissue graft was harvested, after which the flap was coronally positioned over the graft to completely cover it and secured with 4-0 non resorbable.
arm group label: CAF with connective tissue graft
criteria: 
gender: All
minimum age: 20 Years
maximum age: 55 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Dr. D. Y. Patil Dental College & Hospital
investigator full name: Santosh Martande
investigator title: Lecturer
mesh term: Gingival Recession
sharing ipd: No