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The Evaluation Clinical Results of Coronally Advanced Flap With Platelet Rich Fibrin

Primary Purpose

Root Coverage

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Platelet rich fibrin and coronally advanced flap
Connective tissue graft and coronally advanced flap
Sponsored by
Marmara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Root Coverage focused on measuring Gingival recession, Plastic surgery, Platelet rich fibrin, Connective tissue graft, Coronally advanced flap

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients had at two quadrants, adjacent Miller Class I and at least 2 mm or deeper recessions
  • Full mouth plaque score 20% and Full mouth bleeding on probing 10%
  • no active periodontal disease,
  • involving incisors, canines and premolars,
  • age ≥ 18 years

Exclusion Criteria:

  • Patients with general diseases which could affect healing process,
  • smokers
  • Patients had undergone periodontal surgery during the pervious 24 months on the involved sites,
  • pregnant or breastfeeding women
  • endodontic lesions or non-detectable cemento-enamel junctions at experimental teeth

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Platelet rich fibrin and coronally advanced flap

    Connective tissue graft and coronally advanced flap

    Arm Description

    Coronally advanced flap and platelet rich fibrin were used in treatment arms.

    Coronally advanced flap and connective tissue graft were used in treatment arms.

    Outcomes

    Primary Outcome Measures

    Percentage of Root Coverage
    The percentage of root coverage was calculated according to the preoperative recession depth to postoperative recession depth.

    Secondary Outcome Measures

    Complete Root Coverage
    Complete root coverage was calculated according to measurement of the pre and post operative gingival margin which was above the enamel-sement junction.
    Change from Baseline Keratinized Tissue Width at 3 months
    Width of keratinized tissue at mid-buccal point measured from free gingival margin to mucogingival junction
    Change from Baseline Keratinized Tissue Width at 6 months
    Width of keratinized tissue at mid-buccal point measured from free gingival margin to mucogingival junction
    Change from Baseline Keratinized Tissue Width at 12 months
    Width of keratinized tissue at mid-buccal point measured from free gingival margin to mucogingival junction
    Change from Baseline Gingival Thickness at 3 months
    Gingival thickness at mid-buccal aspect measured at the center of keratinized tissue.
    Change from Baseline Gingival Thickness at 6 months
    Gingival thickness at mid-buccal aspect measured at the center of keratinized tissue.
    Change from Baseline Gingival Thickness at 12 months
    Gingival thickness at mid-buccal aspect measured at the center of keratinized tissue.

    Full Information

    First Posted
    June 7, 2021
    Last Updated
    June 19, 2021
    Sponsor
    Marmara University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04942821
    Brief Title
    The Evaluation Clinical Results of Coronally Advanced Flap With Platelet Rich Fibrin
    Official Title
    Treatment of Multiple Adjacent Gingival Recessions With Coronally Advanced Flap in Combination With Platelet-Rich Fibrin: A Split-Mouth Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    April 23, 2014 (Actual)
    Primary Completion Date
    February 24, 2017 (Actual)
    Study Completion Date
    February 24, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Marmara University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of this study was to evaluate the clinical outcomes of platelet- rich fibrin and coronally advanced flap technique in the treatment of multiple gingival recessions in comparison with connective tissue graft technique.
    Detailed Description
    Aim of this study was to evaluate the clinical outcomes of platelet rich fibrin (PRF)+coronally advanced flap (CAF) technique in the treatment of multiple gingival recessions in comparison with connective tissue graft (CTG)+CAF technique.12 patients with bilateral Miller Class I multiple gingival recessions were treated with PRF+CAF (test group) and CTG+CAF (control group) technique in a split-mouth study design. Probing depth, recession depth (RD), clinical attachment level (CAL), recession width, position of gingival margin, papilla width, keratinized tissue height (KTH), keratinized tissue thickness (KTT) were measured at baseline and 3, 6 and 12 months after surgery. Root coverage (RC) and complete root coverage (CRC) ratios were evaluated post-operatively.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Root Coverage
    Keywords
    Gingival recession, Plastic surgery, Platelet rich fibrin, Connective tissue graft, Coronally advanced flap

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    12 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Platelet rich fibrin and coronally advanced flap
    Arm Type
    Experimental
    Arm Description
    Coronally advanced flap and platelet rich fibrin were used in treatment arms.
    Arm Title
    Connective tissue graft and coronally advanced flap
    Arm Type
    Active Comparator
    Arm Description
    Coronally advanced flap and connective tissue graft were used in treatment arms.
    Intervention Type
    Procedure
    Intervention Name(s)
    Platelet rich fibrin and coronally advanced flap
    Intervention Description
    CAF were used in treatment arms. Root planning was performed on the exposed part of roots to provide more biocompatible surface for re-attachment. Two 10 cc tubes with clot activator were used to collect blood from the patient; blood was centrifuged at 2700 rpm for 12 min. PRF box was used to form fibrin clots into membranes. PRF was positioned at the level of the cemento-enamel junction (CEJ), and sutured on the periosteum bed with 6/0 absorbable sutures. Gingival margins on the flap were placed at least 1 mm coronally of the CEJ and sutured with 5/0 absorbable sutures. Sutures were removed at 2nd week.
    Intervention Type
    Procedure
    Intervention Name(s)
    Connective tissue graft and coronally advanced flap
    Intervention Description
    Control sites were treated by coronally advanced flap (CAF) combined with connective tissue graft (CTG). CAF were used in both treatment arms. Root planning was performed on the exposed part of roots to provide more biocompatible surface for re-attachment. CTG was obtained with single incision method. CTG was positioned at the level of the cemento-enamel junction (CEJ), and sutured on the periosteum bed with 6/0 absorbable sutures. Gingival margins on the flap were placed at least 1 mm coronally of the CEJ and sutured with 5/0 absorbable sutures. Sutures were removed at 2nd week.
    Primary Outcome Measure Information:
    Title
    Percentage of Root Coverage
    Description
    The percentage of root coverage was calculated according to the preoperative recession depth to postoperative recession depth.
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Complete Root Coverage
    Description
    Complete root coverage was calculated according to measurement of the pre and post operative gingival margin which was above the enamel-sement junction.
    Time Frame
    12 months
    Title
    Change from Baseline Keratinized Tissue Width at 3 months
    Description
    Width of keratinized tissue at mid-buccal point measured from free gingival margin to mucogingival junction
    Time Frame
    3 months
    Title
    Change from Baseline Keratinized Tissue Width at 6 months
    Description
    Width of keratinized tissue at mid-buccal point measured from free gingival margin to mucogingival junction
    Time Frame
    6 months
    Title
    Change from Baseline Keratinized Tissue Width at 12 months
    Description
    Width of keratinized tissue at mid-buccal point measured from free gingival margin to mucogingival junction
    Time Frame
    12 months
    Title
    Change from Baseline Gingival Thickness at 3 months
    Description
    Gingival thickness at mid-buccal aspect measured at the center of keratinized tissue.
    Time Frame
    3 months
    Title
    Change from Baseline Gingival Thickness at 6 months
    Description
    Gingival thickness at mid-buccal aspect measured at the center of keratinized tissue.
    Time Frame
    6 months
    Title
    Change from Baseline Gingival Thickness at 12 months
    Description
    Gingival thickness at mid-buccal aspect measured at the center of keratinized tissue.
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients had at two quadrants, adjacent Miller Class I and at least 2 mm or deeper recessions Full mouth plaque score 20% and Full mouth bleeding on probing 10% no active periodontal disease, involving incisors, canines and premolars, age ≥ 18 years Exclusion Criteria: Patients with general diseases which could affect healing process, smokers Patients had undergone periodontal surgery during the pervious 24 months on the involved sites, pregnant or breastfeeding women endodontic lesions or non-detectable cemento-enamel junctions at experimental teeth
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hatice Selin Yıldırım, Dr.
    Organizational Affiliation
    Marmara University, Faculty of Denistry, Department of Periodontology
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Başak Doğan, Prof. Dr.
    Organizational Affiliation
    Marmara University, Faculty of Denistry, Department of Periodontology
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Atacan Yavuz, Dr.
    Organizational Affiliation
    Marmara University, Faculty of Denistry, Department of Periodontology
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    The Evaluation Clinical Results of Coronally Advanced Flap With Platelet Rich Fibrin

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