Platelet-rich Fibrin and Connective Tissue Graft in Recession Treatment

Gingival Recession Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02397122
• Other study ID #: KirikkaleU
• Status: Completed
• Phase: N/A
• Start date: February 2013
• Est. completion date: May 2014

Study information

• Verified date: September 2018
• Source: Kirikkale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Gingival Recession

Intervention

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
• 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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kirikkale University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vertical Recession	Measured from cementoenamel junction to margin of the gingiva by periodontal probe	Baseline, 6 weeks and 6 months
Secondary	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
Secondary	Probing Depth	measured from margin of the gingiva to gingival sulcus base by periodontal probe	Baseline, 6 weeks and 6 months
Secondary	Attachment Level	measured from cementoenamel junction to gingival sulcus base by periodontal probe	Baseline, 6 weeks and 6 months
Secondary	Keratinized Tissue Width	measured from margin of the gingiva to mucogingival junction by periodontal probe	Baseline, 6 weeks and 6 months
Secondary	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