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
About this trial
This is an interventional treatment trial for Gingival Recession
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
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
NCT ID
NCT02397122
First Posted
February 13, 2015
Last Updated
September 26, 2018
Sponsor
Kırıkkale University
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
Learn more about this trial
Platelet-rich Fibrin and Connective Tissue Graft in Recession Treatment
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