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Platelet-rich Fibrin and Connective Tissue Graft in Recession Treatment

Primary Purpose

Gingival Recession

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
platelet-rich fibrin
connective tissue graft
coronally advanced flap
Sponsored by
Kırıkkale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Systemically healthy
  • Single Miller type I or II recession defect ≥ 3 mm localized to anterior/premolar area
  • No alveolar bone loss
  • Identifiable cemento-enamel junction
  • Probing depth ≤3mm

Exclusion Criteria:

  • Smoking
  • Pregnancy
  • History of periodontal surgery in last two years
  • Mobility
  • Excessive occlusal contacts
  • Caries
  • Loss of vitality

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    PRF+CAF+CTG

    CAF+CTG

    Arm Description

    platelet-rich fibrin + coronally advanced flap + connective tissue graft

    coronally advanced flap + connective tissue graft

    Outcomes

    Primary Outcome Measures

    Vertical Recession
    Measured from cementoenamel junction to margin of the gingiva by periodontal probe

    Secondary Outcome Measures

    Horizontal Recession
    measured horizontally between two borders of the recession at the line tangential to cementoenamel junction by periodontal probe
    Probing Depth
    measured from margin of the gingiva to gingival sulcus base by periodontal probe
    Attachment Level
    measured from cementoenamel junction to gingival sulcus base by periodontal probe
    Keratinized Tissue Width
    measured from margin of the gingiva to mucogingival junction by periodontal probe
    Tissue Thickness
    under local anesthesia, measured from 1.5 mm below the margin of the gingiva with a spreader and its stopper silicon disc. Then, distance of the marked point was measured by using a standardized caliper to the closest 0.1 mm by periodontal probe

    Full Information

    First Posted
    February 13, 2015
    Last Updated
    September 26, 2018
    Sponsor
    Kırıkkale University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02397122
    Brief Title
    Platelet-rich Fibrin and Connective Tissue Graft in Recession Treatment
    Official Title
    The Adjunctive Effect of Platelet Rich Fibrin to Connective Tissue Graft in the Treatment of Buccal Recession Defects. Results of a Randomized Parallel Group Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2013 (undefined)
    Primary Completion Date
    December 2013 (Actual)
    Study Completion Date
    May 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Kırıkkale University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of the trial is to evaluate the effectiveness of coronally advanced flap (CAF)+connective tissue graft(CTG)+platelet-rich fibrin(PRF) combination in Miller I and II recession treatment by comparing with CAF+CTG. 40 patients were surgically treated either with CAF+CTG+PRF (test group) or CAF+CTG (control group). Clinical parameters of plaque index (PI), gingival index (GI), vertical recession (VR), probing depth (PD), attachment level (AL), keratinized tissue width (KTW), horizontal recession (HR), MGJ localization (L-MGJ), tissue thickness (TT) were recorded at baseline, 3 months (PS1) and 6 months (PS2) post-surgery. Root coverage (RC), complete RC (CRC), attachment gain (AG), and keratinized tissue change (KTC) were also calculated.
    Detailed Description
    Given the encouraging effects of platelet-rich fibrin (PRF) in healing and regeneration, it has been hypothesized that PRF might develop the outcomes obtained with coronally advanced flap (CAF)+connective tissue graft(CTG). Therefore, it was aimed to evaluate the effectiveness of CAF + CTG + PRF in Miller Class I and II recession defect treatment by comparing the outcomes with CAF + CTG in a preliminary, controlled, randomized clinical trial (RCT) with a 6-month follow-up. The study was conducted with 40 patients randomly grouped in half shares into indicated study groups. After phase I therapy, clinical variables including plaque index (PI), gingival index (GI), vertical recession (VR), probing depth (PD), attachment level (AL), keratinized tissue width (KTW), horizontal recession (HR), MGJ localization (L-MGJ), tissue thickness (TT) were recorded. The surgical sites were prepared by using sulcular and adjacent vertical incisions and CTGs were harvested from the palatal regions. Different from CAF+CTG group, PRF was prepared by obtaining 10 ml venous blood, centrifugation and extraction of the gel containing highly concentrated platelet cells in CAF+CTG+PRF patients. Then the gel was placed over the exposed root surface in the same group. The CAF was primarily closed and postoperative instructions were given. After suture removal at second postoperative week, the patients were followed-up by monthly recall visits. Same periodontal clinical variables were recorded 3 and 6 months after surgery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gingival Recession

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    PRF+CAF+CTG
    Arm Type
    Experimental
    Arm Description
    platelet-rich fibrin + coronally advanced flap + connective tissue graft
    Arm Title
    CAF+CTG
    Arm Type
    Active Comparator
    Arm Description
    coronally advanced flap + connective tissue graft
    Intervention Type
    Biological
    Intervention Name(s)
    platelet-rich fibrin
    Intervention Description
    autologous platelet-rich fibrin was isolated from venous blood of each patient by defined centrifugation methods
    Intervention Type
    Procedure
    Intervention Name(s)
    connective tissue graft
    Intervention Description
    connective tissue graft was harvested from the palatal region of each patient by single incision method
    Intervention Type
    Procedure
    Intervention Name(s)
    coronally advanced flap
    Intervention Description
    buccal gingival flap was raised by sharp-blunt-sharp dissection and positioned coronally to cover connective tissue graft (and platelet-rich fibrin gel)
    Primary Outcome Measure Information:
    Title
    Vertical Recession
    Description
    Measured from cementoenamel junction to margin of the gingiva by periodontal probe
    Time Frame
    Baseline, 6 weeks and 6 months
    Secondary Outcome Measure Information:
    Title
    Horizontal Recession
    Description
    measured horizontally between two borders of the recession at the line tangential to cementoenamel junction by periodontal probe
    Time Frame
    Baseline, 6 weeks and 6 months
    Title
    Probing Depth
    Description
    measured from margin of the gingiva to gingival sulcus base by periodontal probe
    Time Frame
    Baseline, 6 weeks and 6 months
    Title
    Attachment Level
    Description
    measured from cementoenamel junction to gingival sulcus base by periodontal probe
    Time Frame
    Baseline, 6 weeks and 6 months
    Title
    Keratinized Tissue Width
    Description
    measured from margin of the gingiva to mucogingival junction by periodontal probe
    Time Frame
    Baseline, 6 weeks and 6 months
    Title
    Tissue Thickness
    Description
    under local anesthesia, measured from 1.5 mm below the margin of the gingiva with a spreader and its stopper silicon disc. Then, distance of the marked point was measured by using a standardized caliper to the closest 0.1 mm by periodontal probe
    Time Frame
    Baseline, 6 weeks and 6 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Systemically healthy Single Miller type I or II recession defect ≥ 3 mm localized to anterior/premolar area No alveolar bone loss Identifiable cemento-enamel junction Probing depth ≤3mm Exclusion Criteria: Smoking Pregnancy History of periodontal surgery in last two years Mobility Excessive occlusal contacts Caries Loss of vitality

    12. IPD Sharing Statement

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