<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/NCT03043638</url>
  </required_header>
  <id_info>
    <org_study_id>03/2007-28</org_study_id>
    <nct_id>NCT03043638</nct_id>
  </id_info>
  <brief_title>Efficiency of PRP on Acellular Dermal Matrix Application in the Treatment of Multiple Adjacent Gingival Recessions</brief_title>
  <acronym>PRP</acronym>
  <official_title>Efficiency of Platelet-Rich Plasma (PRP) on Acellular Dermal Matrix Application With Coronally Advanced Flap in the Treatment of Multiple Adjacent Gingival Recessions:a Double-masked Randomized Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Gazi University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization</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>
      The aim of this study was to evaluate the effectiveness of platelet rich plasma (PRP)&#xD;
      combined with coronally advanced flap plus acellular dermal matrix application (CAF+ADM) in&#xD;
      the treatment of multiple adjacent gingival recessions (MAGRs).&#xD;
&#xD;
      12 patients with 84 Miller Class I or II recession defects were participated. Sites were&#xD;
      randomly assigned into CAF+ADM+PRP or CAF+ADM groups. Gingival recession depth (GRD),&#xD;
      recession width (GRW), width of keratinized tissue (WKT), creeping attachment (CRA), root&#xD;
      coverage (RC) as well as plaque index, gingival index, probing depth (PD), and clinical&#xD;
      attachment level (CAL) were recorded at baseline and 3rd,6th and 12th months postoperatively.&#xD;
      The data were analyzed statistically.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Several methods have been demonstrated for the treatment of gingival recession defects with&#xD;
      the use of PRP. In an 8-month randomized controlled trial, it was reported that there was no&#xD;
      significant difference between PRP and CTG treated groups in terms of root coverage of Miller&#xD;
      Class 1 or II buccal recession defects. However, in the same study contour and texture of&#xD;
      soft tissue showed valuable enhancement in PRP group. The use of PRP together with ADM in the&#xD;
      treatment of MAGRs may alleviate the need for autogenous donor tissue. Shepherd et al.&#xD;
      compared coronally positioned tunnel technique and ADM application with and without PRP for&#xD;
      the treatment of single gingival recession defects and reported no statistically significant&#xD;
      root coverage difference between groups.&#xD;
&#xD;
      Although there are numerous root coverage procedures to treat the conditions, predictable&#xD;
      coverage of multiple adjacent gingival recessions still remains a challenge for the&#xD;
      clinician. The aim of this randomized, controlled, clinical trial was to compare the CAF plus&#xD;
      ADM application together with and without PRP to determine whether the PRP provided an&#xD;
      advantage in terms of gaining coverage of deep and wide recession defects in the treatment of&#xD;
      MAGRs.&#xD;
&#xD;
      In the present study, using a controlled blinded split-mouth design, 14 patients with&#xD;
      multiple Miller Class I or II adjacent recession defects ≥ 3mm deep on bilateral operation&#xD;
      sites were randomly operated either with CAF+ADM+PRP or only CAF+ADM as test and control&#xD;
      groups respectively. Two patients who failed to return for all postoperative visits were&#xD;
      exited from the study.&#xD;
&#xD;
      Finally12 patients who had adjacent Miller Class 1 or II (Miller) recession defects ≥ 3mm&#xD;
      deep on non-molar teeth in the same dental arch at least two bilateral site, underwent&#xD;
      through root coverage surgery and were followed for 12 months. The study sample consisted of&#xD;
      84 teeth associated with total of 12 patients; seven patients each showing a pair of three&#xD;
      teeth, four patients each showing a pair of four teeth, and one patient showing a pair of&#xD;
      five teeth with adjacent multiple recessions deep on the buccal aspect of each tooth. The&#xD;
      treated teeth were 26 incisors, 24 canines and 34 first premolars. Standardized radiographs&#xD;
      were taken to evaluate the interproximal alveolar bone level. At baseline, 3, 6 and 12 months&#xD;
      after the surgeries; Miller classification of the recession defect (Miller, 1985), plaque&#xD;
      index (PI) (Silness and Loe, 1964), gingival index (GI) (Loe, 1967) probing depth (PD),&#xD;
      clinical attachment level(CAL), Probing depth(PD), gingival margin (GM), Gingival recession&#xD;
      width (GRW) were recorded. The pre-surgical evaluation included an analysis of the patient's&#xD;
      tooth brushing technique and habits. At the teeth showing gingival recessions, a coronally&#xD;
      directed roll technique using a soft toothbrush was indicated to minimize the tooth brushing&#xD;
      trauma to the gingival margin. Pre-surgical therapy included scaling, root planning,&#xD;
      polishing and general oral hygiene instruction. All surgical procedures were performed with&#xD;
      Coronally Advanced Flap technique.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2008</start_date>
  <completion_date type="Actual">June 20, 2011</completion_date>
  <primary_completion_date type="Actual">June 20, 2011</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>Root coverage (RC)</measure>
    <time_frame>The change in RC at 3rd month to 12th month</time_frame>
    <description>The percentage of root coverage (RC) was calculated as ([GRD preoperation - GRD postoperation] / GRD preoperation) x 100%.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gingival recession depth (GRD)</measure>
    <time_frame>Baseline, 3,6 and 12 months after periodontal surgery</time_frame>
    <description>The GRD was measured from the CEJ to the GM. PD, CAL and GRD were measured at the same reference points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>recession width (GRW)</measure>
    <time_frame>Baseline, 3,6 and 12 months after periodontal surgery</time_frame>
    <description>Gingival recession width (GRW) was measured with perpendicular positioning of the periodontal probe to the cemento-enamel junction, the distance between the top of the papilla at the mesial and distal aspect of the tooth was recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>width of keratinized tissue (WKT)</measure>
    <time_frame>Baseline, 3,6 and 12 months after periodontal surgery</time_frame>
    <description>Width of keratinized tissue (WKT) was measured at the mid-buccal point from the mucogingival junction (MGJ) to the free GM by a digital caliper.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>plaque index(PI)</measure>
    <time_frame>Baseline, 3,6 and 12 months after periodontal surgery</time_frame>
    <description>plaque index were calculated as a sum of mean scores by each examined tooth divided by the number of evaluated teeth. A mean of all measurements for each patient was considered.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>gingival index</measure>
    <time_frame>Baseline, 3,6 and 12 months after periodontal surgery</time_frame>
    <description>gingival index were calculated as a sum of mean scores by each examined tooth divided by the number of evaluated teeth. A mean of all measurements for each patient was considered.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>probing depth</measure>
    <time_frame>Baseline, 3,6 and 12 months after periodontal surgery</time_frame>
    <description>PD was measured at three points (mesio-buccal, midbuccal, and disto-buccal) on the individual elastomeric stent and calculated as the distance between gingival margin (GM) and the bottom of the sulcus.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Gingival Recession, Generalized</condition>
  <arm_group>
    <arm_group_label>CAF+ADM+PRP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Surgery will include Coronally advanced flap(CAF) plus acellular dermal matrix (ADM) combined with platelet rich plasma (PRP)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CAF+ADM</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Surgery will include only Coronally advanced flap CAF technique including ADM placement without PRP</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>CAF+ADM+PRP</intervention_name>
    <description>CAF+ADM+PRP group treated with coronally advanced flap technique including ADM placement, In CAF+ADM+PRP group, ADM was hydrated in the platelet-poor plasma (PPP) and the PRP was applied to surgical sites prior to final suturing.</description>
    <arm_group_label>CAF+ADM+PRP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>CAF+ADM</intervention_name>
    <description>CAF+ADM group treated with coronally advanced flap technique including ADM placement without PRP application</description>
    <arm_group_label>CAF+ADM</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Clinical diagnosis of the presence of at least three multiple adjacent Miller class I&#xD;
             or II recessions on both sides of the same maxillary or mandibular arch&#xD;
&#xD;
          2. must be able to have 2 mm-high keratinized tissue apical to the root exposures;&#xD;
&#xD;
          3. must be able to have no systemic diseases that could influence the outcome of the&#xD;
             therapy;&#xD;
&#xD;
          4. must be able to have a full-mouth plaque score of 20% (O'Leary et al. 1972);&#xD;
&#xD;
          5. must be non-smoker;&#xD;
&#xD;
          6. must be not pregnant.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  debilitating systemic or infectious diseases (human immunodeficiency virus or&#xD;
             hepatitis) -- -any disease that significantly affects the periodontium;&#xD;
&#xD;
          -  known allergy to any of the materials used in the study; requirement for antibiotic&#xD;
             prophylaxis;&#xD;
&#xD;
          -  taking medications known to interfere with periodontal health and healing not&#xD;
             detectable cemento-enamel junction (CEJ);&#xD;
&#xD;
          -  restorations or caries at the recession site;&#xD;
&#xD;
          -  failure to maintain an oral hygiene level ≥80% plaque-free surfaces; pregnancy or&#xD;
             lactation; use of tobacco products; alcohol abuse;&#xD;
&#xD;
          -  a previous periodontal surgery at the recession site and failure to complete the&#xD;
             informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>34 Years</minimum_age>
    <maximum_age>57 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pelin Gokalp</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gazi University</affiliation>
  </overall_official>
  <reference>
    <citation>Shepherd N, Greenwell H, Hill M, Vidal R, Scheetz JP. Root coverage using acellular dermal matrix and comparing a coronally positioned tunnel with and without platelet-rich plasma: a pilot study in humans. J Periodontol. 2009 Mar;80(3):397-404. doi: 10.1902/jop.2009.080438.</citation>
    <PMID>19254123</PMID>
  </reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>February 2, 2017</study_first_submitted>
  <study_first_submitted_qc>February 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 6, 2017</study_first_posted>
  <last_update_submitted>February 6, 2017</last_update_submitted>
  <last_update_submitted_qc>February 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization</investigator_affiliation>
    <investigator_full_name>PELİN GÖKALP</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>multiple adjacent gingival recessions</keyword>
  <keyword>platelet rich plasma</keyword>
  <keyword>acellular dermal matrix</keyword>
  <keyword>coronally advanced flap</keyword>
  <keyword>gingival recession</keyword>
  <keyword>root coverage</keyword>
  <keyword>clinical attachment level</keyword>
  <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>Yes</sharing_ipd>
    <ipd_description>When needed data can be shared via email.</ipd_description>
  </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/NCT03043638
org study id: 03/2007-28
nct id: NCT03043638
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study was to evaluate the effectiveness of platelet rich plasma (PRP)
      combined with coronally advanced flap plus acellular dermal matrix application (CAF+ADM) in
      the treatment of multiple adjacent gingival recessions (MAGRs).

      12 patients with 84 Miller Class I or II recession defects were participated. Sites were
      randomly assigned into CAF+ADM+PRP or CAF+ADM groups. Gingival recession depth (GRD),
      recession width (GRW), width of keratinized tissue (WKT), creeping attachment (CRA), root
      coverage (RC) as well as plaque index, gingival index, probing depth (PD), and clinical
      attachment level (CAL) were recorded at baseline and 3rd,6th and 12th months postoperatively.
      The data were analyzed statistically.
Several methods have been demonstrated for the treatment of gingival recession defects with
      the use of PRP. In an 8-month randomized controlled trial, it was reported that there was no
      significant difference between PRP and CTG treated groups in terms of root coverage of Miller
      Class 1 or II buccal recession defects. However, in the same study contour and texture of
      soft tissue showed valuable enhancement in PRP group. The use of PRP together with ADM in the
      treatment of MAGRs may alleviate the need for autogenous donor tissue. Shepherd et al.
      compared coronally positioned tunnel technique and ADM application with and without PRP for
      the treatment of single gingival recession defects and reported no statistically significant
      root coverage difference between groups.

      Although there are numerous root coverage procedures to treat the conditions, predictable
      coverage of multiple adjacent gingival recessions still remains a challenge for the
      clinician. The aim of this randomized, controlled, clinical trial was to compare the CAF plus
      ADM application together with and without PRP to determine whether the PRP provided an
      advantage in terms of gaining coverage of deep and wide recession defects in the treatment of
      MAGRs.

      In the present study, using a controlled blinded split-mouth design, 14 patients with
      multiple Miller Class I or II adjacent recession defects ≥ 3mm deep on bilateral operation
      sites were randomly operated either with CAF+ADM+PRP or only CAF+ADM as test and control
      groups respectively. Two patients who failed to return for all postoperative visits were
      exited from the study.

      Finally12 patients who had adjacent Miller Class 1 or II (Miller) recession defects ≥ 3mm
      deep on non-molar teeth in the same dental arch at least two bilateral site, underwent
      through root coverage surgery and were followed for 12 months. The study sample consisted of
      84 teeth associated with total of 12 patients; seven patients each showing a pair of three
      teeth, four patients each showing a pair of four teeth, and one patient showing a pair of
      five teeth with adjacent multiple recessions deep on the buccal aspect of each tooth. The
      treated teeth were 26 incisors, 24 canines and 34 first premolars. Standardized radiographs
      were taken to evaluate the interproximal alveolar bone level. At baseline, 3, 6 and 12 months
      after the surgeries; Miller classification of the recession defect (Miller, 1985), plaque
      index (PI) (Silness and Loe, 1964), gingival index (GI) (Loe, 1967) probing depth (PD),
      clinical attachment level(CAL), Probing depth(PD), gingival margin (GM), Gingival recession
      width (GRW) were recorded. The pre-surgical evaluation included an analysis of the patient's
      tooth brushing technique and habits. At the teeth showing gingival recessions, a coronally
      directed roll technique using a soft toothbrush was indicated to minimize the tooth brushing
      trauma to the gingival margin. Pre-surgical therapy included scaling, root planning,
      polishing and general oral hygiene instruction. All surgical procedures were performed with
      Coronally Advanced Flap technique.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Root coverage (RC)
time frame: The change in RC at 3rd month to 12th month
description: The percentage of root coverage (RC) was calculated as ([GRD preoperation - GRD postoperation] / GRD preoperation) x 100%.
measure: Gingival recession depth (GRD)
time frame: Baseline, 3,6 and 12 months after periodontal surgery
description: The GRD was measured from the CEJ to the GM. PD, CAL and GRD were measured at the same reference points.
measure: recession width (GRW)
time frame: Baseline, 3,6 and 12 months after periodontal surgery
description: Gingival recession width (GRW) was measured with perpendicular positioning of the periodontal probe to the cemento-enamel junction, the distance between the top of the papilla at the mesial and distal aspect of the tooth was recorded.
measure: width of keratinized tissue (WKT)
time frame: Baseline, 3,6 and 12 months after periodontal surgery
description: Width of keratinized tissue (WKT) was measured at the mid-buccal point from the mucogingival junction (MGJ) to the free GM by a digital caliper.
measure: plaque index(PI)
time frame: Baseline, 3,6 and 12 months after periodontal surgery
description: plaque index were calculated as a sum of mean scores by each examined tooth divided by the number of evaluated teeth. A mean of all measurements for each patient was considered.
measure: gingival index
time frame: Baseline, 3,6 and 12 months after periodontal surgery
description: gingival index were calculated as a sum of mean scores by each examined tooth divided by the number of evaluated teeth. A mean of all measurements for each patient was considered.
measure: probing depth
time frame: Baseline, 3,6 and 12 months after periodontal surgery
description: PD was measured at three points (mesio-buccal, midbuccal, and disto-buccal) on the individual elastomeric stent and calculated as the distance between gingival margin (GM) and the bottom of the sulcus.
arm group label: CAF+ADM+PRP
arm group type: Experimental
description: Surgery will include Coronally advanced flap(CAF) plus acellular dermal matrix (ADM) combined with platelet rich plasma (PRP)
arm group label: CAF+ADM
arm group type: Active Comparator
description: Surgery will include only Coronally advanced flap CAF technique including ADM placement without PRP
intervention type: Procedure
intervention name: CAF+ADM+PRP
description: CAF+ADM+PRP group treated with coronally advanced flap technique including ADM placement, In CAF+ADM+PRP group, ADM was hydrated in the platelet-poor plasma (PPP) and the PRP was applied to surgical sites prior to final suturing.
arm group label: CAF+ADM+PRP
intervention type: Procedure
intervention name: CAF+ADM
description: CAF+ADM group treated with coronally advanced flap technique including ADM placement without PRP application
arm group label: CAF+ADM
criteria: 
gender: All
minimum age: 34 Years
maximum age: 57 Years
healthy volunteers: No
last name: Pelin Gokalp
role: Principal Investigator
affiliation: Gazi University
citation: Shepherd N, Greenwell H, Hill M, Vidal R, Scheetz JP. Root coverage using acellular dermal matrix and comparing a coronally positioned tunnel with and without platelet-rich plasma: a pilot study in humans. J Periodontol. 2009 Mar;80(3):397-404. doi: 10.1902/jop.2009.080438.
PMID: 19254123
responsible party type: Principal Investigator
investigator affiliation: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
investigator full name: PELİN GÖKALP
investigator title: Principal Investigator
mesh term: Gingival Recession
sharing ipd: Yes
ipd description: When needed data can be shared via email.