PRF for Treating Maxillary Gingival Recession

PRF for Treating Maxillary Gingival Recessions: A Split-mouth, Randomized, Controlled Clinical Trial

This is a split-mouth, randomized, controlled clinical trial that aims to evaluate the clinical efficacy of platelet-rich fibrin (PRF) membranes in conjunction with coronally advanced flap (CAF) in treating maxillary gingival recession defects.

Study Overview

• Status: Completed
• Conditions: Gingival Recession
• Intervention / Treatment: Procedure: Gingival coverage using coronally advanced flap and a connective tissue graft; Procedure: Gingival coverage using coronally advanced flap and platelet rich fibrin membranes

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Palestinian Territory, occupied
  • Ramallah, Palestinian Territory, occupied, 240
    • Arab American University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Greater than 18 years old
• Bilateral Miller class I + II recession in the upper jaw

Exclusion Criteria:

• Smokers
• Patients with systemic diseases that could interfere with the healing
• Patients undergoing bisphosphonate therap .Patients who previously received radiation therapy of the jaws.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: coronally advanced flap with connective tissue graft; After randomization a subepithelial connective tissue graft along with coronally advanced flap is applied to one maxillary quadrant to cover the recession.	Procedure: Gingival coverage using coronally advanced flap and a connective tissue graft; A coronally advanced flap is applied for recession coverage in the maxilla in a split-mouth randomized trial using a subepithelial connective tissue graft
Experimental: coronally advanced flap with platelet rich fibrin membranes; After randomization platelet rich fibrin membranes along with coronally advanced flap are applied to the other maxillary quadrant to cover the recession.	Procedure: Gingival coverage using coronally advanced flap and platelet rich fibrin membranes; A coronally advanced flap is applied for recession coverage in the maxilla in a split-mouth randomized trial using platelet rich fibrin membranes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Increase in gingival height (recession coverage)	The measurements of the increase in gingival height (recession coverage) using a linear evaluation (corono-apical direction) with a periodontal probe (Merrit-B; Hu-Friedy, Chicago, IL, USA) at the interventions sites to the nearest 0.5 mm. Registration of the recession height was done before treatment and after 6 weeks.	six weeks
Shrinkage in gingival height	To assess the shrinkage of the gingival height, the amount of gingival height vestibular to the treated teeth in a corono-apical direction was measured after the surgery and after six months.	six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain visual analog scores (VAS) and surgery time	This questionnaire used 100 mm visual analog scores VAS to evaluate the amount of pain, ranging from 0 (no pain) to 10 (worst pain imaginable), and the amount of swelling. Patients were asked to fill in the VAS scales at day 7 and day 14 at suture removal. The time of surgery was measured of both treatment options. Timing started at the moment of first incision until the last suture.	two weeks

Collaborators and Investigators

• Sponsor: Arab American University (Palestine)
• Investigators: Principal Investigator: Mahmoud F Abu-Ta'a, Periodontist, Head of Department

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2021
• Primary Completion (Actual): August 15, 2021
• Study Completion (Actual): November 14, 2021

Study Registration Dates

• First Submitted: February 14, 2022
• First Submitted That Met QC Criteria: February 23, 2022
• First Posted (Actual): March 4, 2022

Study Record Updates

• Last Update Posted (Actual): March 4, 2022
• Last Update Submitted That Met QC Criteria: February 23, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: gingival recession; connective tissue graft; PRF membrane
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession
• Other Study ID Numbers: ArabAmericanU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No