Platelet-rich Fibrin and Connective Tissue Graft in Recession Treatment

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

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.

Study Overview

• Status: Completed
• Conditions: Gingival Recession
• Intervention / Treatment: Biological: platelet-rich fibrin; Procedure: connective tissue graft; Procedure: coronally advanced flap

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PRF+CAF+CTG; platelet-rich fibrin + coronally advanced flap + connective tissue graft	Biological: platelet-rich fibrin; autologous platelet-rich fibrin was isolated from venous blood of each patient by defined centrifugation methods; Procedure: connective tissue graft; connective tissue graft was harvested from the palatal region of each patient by single incision method; Procedure: coronally advanced flap; buccal gingival flap was raised by sharp-blunt-sharp dissection and positioned coronally to cover connective tissue graft (and platelet-rich fibrin gel)
Active Comparator: CAF+CTG; coronally advanced flap + connective tissue graft	Procedure: connective tissue graft; connective tissue graft was harvested from the palatal region of each patient by single incision method; Procedure: coronally advanced flap; buccal gingival flap was raised by sharp-blunt-sharp dissection and positioned coronally to cover connective tissue graft (and platelet-rich fibrin gel)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vertical Recession	Measured from cementoenamel junction to margin of the gingiva by periodontal probe	Baseline, 6 weeks and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Horizontal Recession	measured horizontally between two borders of the recession at the line tangential to cementoenamel junction by periodontal probe	Baseline, 6 weeks and 6 months
Probing Depth	measured from margin of the gingiva to gingival sulcus base by periodontal probe	Baseline, 6 weeks and 6 months
Attachment Level	measured from cementoenamel junction to gingival sulcus base by periodontal probe	Baseline, 6 weeks and 6 months
Keratinized Tissue Width	measured from margin of the gingiva to mucogingival junction by periodontal probe	Baseline, 6 weeks and 6 months
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	Baseline, 6 weeks and 6 months

Collaborators and Investigators

• Sponsor: Kırıkkale University

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: February 13, 2015
• First Submitted That Met QC Criteria: March 18, 2015
• First Posted (Estimate): March 24, 2015

Study Record Updates

• Last Update Posted (Actual): October 26, 2018
• Last Update Submitted That Met QC Criteria: September 26, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession
• Other Study ID Numbers: KirikkaleU