Platelet-Rich Fibrin in the Treatment of Multiple Gingival Recessions

Platelet Rich Fibrin Against Connective Tissue Graft in Treatment of Gingival Recessions

The main objective of this study was to evaluate the clinical effectiveness of platelet-rich fibrin membrane used in combination with a coronally advanced flap and to compare it with the use of a subepitelial connective tissue graft in combination with a coronally advanced flap in Miller class I-II bilateral gingival recession treatment

Study Overview

• Status: Completed
• Conditions: Gingival Recessions
• Intervention / Treatment: Procedure: test groups; Procedure: Control groups

Detailed Description

Purpose

The main objective of this study was to evaluate the clinical effectiveness of platelet-rich fibrin (PRF) in combination with modified coronally advanced flap (MCAF) in the treatment of multiple gingival recessions. Furthermore the second aim of the present study was to compare plastic periodontal surgical procedure, with PRF membrane and connective tissue graft, by a randomized splitmouth controlled study.

Clinical effectiveness of platelet-rich fibrin (PRF) in combination with modified coronally advanced flap (MCAF) as measured by Clinical measurements.

Material and Methods

Twenty patients with multiple gingival recession defects (Miller I, II) participated in this split-mouth trial. Sixty defects received either MCAF+PRF (test) or MCAF with subepithelial connective tissue graft (SCTG) (control). Gingival recession depth (RD), gingival recession width (RW), keratinized tissue width (KTW), recession area (RA), probing depth (PD), clinical attachment level (CAL) and gingival thickness (GT) were evaluated at baseline and 6 months. Additionally post-surgery patient satisfaction and pain status were measured by comparing visual analogue scale (VAS) scores.

Clinical measurements were taken at starting point and 6 months postoperatively. The measurements comprised an assessment of probing depth (PD),clinical attachment level (CAL) and gingival recession parameters including recession depth (RD), recession width (RW), keratinized tissue width (KTW) and gingival thickness (GT) were assessed by a calibrated examiner (E. Ö.). PD, CAL, RD, RW and KTW values were recorded by a Williams probe graduated in 1-mm increments and rounded up to the nearest millimeter (Hu Friedy, Chicago, IL, USA). To standardize the clinical measurements acrylic stents were prepared on patients' casts. The following measurements were recorded at the mid-buccal point of the teeth at baseline and6 months after surgery. GT was evaluated using endodontic reamer attached to a rubber stopper inserted perpendicularly into the gingival tissue 3 mm below the gingival margin under local anesthesia, and then the thickness was measured to the nearest 0.1 mm using a caliper.RD was measured from the CEJ to the gingival margin, RW was measured tangentially at the mid-facial CEJ and RA was calculated as the area within the contour of denuded root. KTW recorded as the distance from the mucogingival junction to the gingival margin. Duplicate measurements were made for RD, RW, RA and KTW with an interval of 24 hours and the average value of two measurements was used for the assessment. The postoperative pain was evaluated with a visual analog score (VAS).

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Turkey
  • Konya, Turkey, 42060
    • NEU Dental School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• non smoking,
• similar bilateral Miller Class I or II20 localized gingival recessions at least ≥3 mm, located on incisors, canines or premolars on both jaws,
• identifiable cemento-enamel junction (CEJ),
• age ≥18 years,
• presence of tooth vitality and absence of restorations and superficial caries in the area to be treated,
• no periodontal surgical treatment on the involved sites,
• sufficient palatal donor tissue at least ≥2.5 mm thickness for the indicated SCTG

Exclusion Criteria:

• Patients in a pregnancy or lactation period or with self-reported history of antibiotic medication within 6 months
• Molar, mobile or fully restorated teeth

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test groups.; This clinical study was designed as a split-mouth, randomized, controlled clinical trial. Bilateral gingival recession defects were randomly assigned to the test (CAF+PRF) or the control (CAF+SCTG) groups with the use of computer-generated randomization table after assessment of clinical parameters at baseline.	Procedure: test groups; At the test sites, the previously prepared PRF was positioned over the recession defects, the coronal margin of the PRF was placed at the CEJ; Other Names: PRF groups
Active Comparator: Control groups.; This clinical study was designed as a split-mouth, randomized, controlled clinical trial. Bilateral gingival recession defects were randomly assigned to the test (CAF+PRF) or the control (CAF+SCTG) groups with the use of computer-generated randomization table after assessment of clinical parameters at baseline.	Procedure: Control groups; Split-full-split thickness flap incisions were performed in a coronal-apical direction. The papillae adjacent to the involved tooth were de-epithelialized to create a connective tissue bed. The gingival flap was repositioned without tension, with its margin located on the enamel, on the test and control sides. It was held in that position with 5-0 resoble sutures; Other Names: Connective tissue graft groups

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete root coverage	Change from baseline in gingival recession will be assessed at 1, 3 and 6 months.	6 months
Gingival recession depth	Change from baseline in gingival recession will be assessed at 6 months	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Keratinized tissue width	Change from baseline in keratinized tissue at 6 months.	6 months
Pain scores	Pain level evaluated on visual analog scale	first week after operations

Collaborators and Investigators

• Sponsor: Necmettin Erbakan University
• Investigators: Study Director: ELİF ÖNCÜ, PhD, Necmettin Erbakan University

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: December 13, 2014
• First Submitted That Met QC Criteria: January 7, 2015
• First Posted (Estimate): January 12, 2015

Study Record Updates

• Last Update Posted (Estimate): January 12, 2015
• Last Update Submitted That Met QC Criteria: January 7, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: Gingival Recession; Platelet rich fibrin
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession
• Other Study ID Numbers: 2014/10