Platelet Rich Fibrin in the Treatment of Multiple Gingival Recessions

Not Applicable

Completed

• Conditions: Gingival Recession
• Interventions: Procedure: connective tissue graft; Procedure: platelet rich fibrin

• Registration Number: NCT02018120
• Lead Sponsor: Ege University

Brief Summary

The aim of this randomized controlled clinical study is to evaluate and compare the effectiveness of platelet rich fibrin (PRF) and connective tissue grafts in the treatment of multiple gingival recessions.

Detailed Description

The aim of this randomized controlled clinical study is to evaluate and compare the effectiveness of platelet rich fibrin (PRF) and connective tissue grafts in the treatment of multiple gingival recessions.

Primary outcome variables were percentage of complete root coverage and mean root coverage percentages at 6 months follow up. The secondary outcome variables include keratinized tissue and gingival thickness gain.

Sample size has been estimated as 13 in each treatment arm. All recessions are treated with modified coronally advanced flap. On test sites PRF membrane and on control sites connective tissue grafts will be placed under modified coronally advanced flaps. Random allocation of the treatment sites to test and control groups were performed using a computer software designed for randomization.

Clinical parameters such as gingival index, plaque index, keratinized tissue width, gingival recession depth and width were measured at 1, 3 and 6 months. Probing pocket depth, clinical attachment level, gingival thickness and gingival recession area were measure at baseline and 6 months. All gingival recession-related parameters such as recession height, recession width and recession area and keratinized tissue width along with mean root coverage and complete root coverage were assessed on standardized clinical photographs using an image analysis software.

Clinical photographs were obtained at baseline and 1, 3 and 6 months after surgical intervention. 4 mm length wire was placed on gingiva to check reproducibility and to obtain standardized pictures.

Gingival tissue thickness were measured with an #15 endodontic reamer attached to rubber stopper inserted perpendicularly into the gingival tissue 2 mm below the gingival margin; thickness of the reamer will be measured with a digital caliper.

Mean root coverage percentage was calculated as percentage of covered root surface area at 6 months.

Follow up of subjects was 6 months.

Study Timeline

• Study Start: 2012-05
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2013-12
• Study First Submitted: 2013-12-17
• Study First Submitted QC: 2013-12-20
• Last Update Submitted: 2013-12-20
• Study First Posted: 2013-12-23
• Last Update Posted: 2013-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• Two or more adjacent teeth with at least 2 mm Miller Class I gingival recessions at non-molar teeth
• Identifiable CEJ on all teeth
• Age ≥ 18
• Presence of tooth vitality and absence of restorations and superficial caries in the treatment area
• No past surgical treatment history of affected area.
• Gingival thickness ≥ 0,8 mm for recession areas.
• Sufficient palatal donor tissue for connective tissue harvesting.

Exclusion Criteria

• Smoking
• Pregnancy or lactation
• Systematic diseases that may affect outcomes of periodontal therapy
• Self-reported antibiotic medication within three months
• Occlusal trauma in treatment site

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
connective tissue graft	connective tissue graft	connective tissue graft harvested from palatum of subjects and placed under modified coronally advanced flap
Platelet rich fibrin	platelet rich fibrin	Autogenous platelet rich fibrin was obtained from subjects own blood samples after centrifugation. Platelet rich fibrin membranes were placed under modified coronally advanced flaps.

Primary Outcome Measures

Name	Time	Method
Mean root coverage percentage	6 months	mean area of root coverage achieved by surgical root coverage therapy.
complete root coverage percentage	6 months	percentage of gingival recession defects completely covered by flaps after 6 months

Secondary Outcome Measures

Name	Time	Method
keratinized tissue width	6 months	changes in keratinized tissue width at 6 months
gingival tissue thickness	6 months	changes from baseline in gingival tissue thickness at 6 months

Trial Locations

Locations (1)

Ege University School of Dentistry Department of Periodontology; 🇹🇷 Izmir, Bornova, Turkey