Platelet-rich Fibrin and Connective Tissue Graft in Recession Treatment

Not Applicable

Completed

Conditions: Gingival Recession

Interventions: Procedure: connective tissue graft
Biological: platelet-rich fibrin
Procedure: coronally advanced flap

Registration Number: NCT02397122

Lead Sponsor: Kırıkkale University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 40

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CAF+CTG	connective tissue graft	coronally advanced flap + connective tissue graft
CAF+CTG	coronally advanced flap	coronally advanced flap + connective tissue graft
PRF+CAF+CTG	platelet-rich fibrin	platelet-rich fibrin + coronally advanced flap + connective tissue graft
PRF+CAF+CTG	connective tissue graft	platelet-rich fibrin + coronally advanced flap + connective tissue graft
PRF+CAF+CTG	coronally advanced flap	platelet-rich fibrin + coronally advanced flap + connective tissue graft

Primary Outcome Measures

Name	Time	Method
Vertical Recession	Baseline, 6 weeks and 6 months	Measured from cementoenamel junction to margin of the gingiva by periodontal probe

Secondary Outcome Measures

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