Platelet Rich Fibrin in the Treatment of Multiple Gingival Recessions

Gingival Recession Clinical Trial

Official title:

Comparison of Platelet Rich Fibrin and Connective Tissue Graft in Treatment of Multiple Gingival Recessions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02018120
• Other study ID #: 2012-Dis-004
• Status: Completed
• Phase: N/A
• First received: December 17, 2013
• Last updated: December 20, 2013
• Start date: May 2012
• Est. completion date: August 2013

Study information

• Verified date: December 2013
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gingival Recession

Intervention

Procedure:
• connective tissue graft

• platelet rich fibrin

Locations

Country	Name	City	State
Turkey	Ege University School of Dentistry Department of Periodontology	Izmir	Bornova

Sponsors (1)

Lead Sponsor	Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean root coverage percentage	mean area of root coverage achieved by surgical root coverage therapy.	6 months	No
Primary	complete root coverage percentage	percentage of gingival recession defects completely covered by flaps after 6 months	6 months	No
Secondary	keratinized tissue width	changes in keratinized tissue width at 6 months	6 months	No
Secondary	gingival tissue thickness	changes from baseline in gingival tissue thickness at 6 months	6 months	No