Platelet-Rich Fibrin in the Treatment of Multiple Gingival Recessions

Gingival Recessions Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02335866
• Other study ID #: 2014/10
• Status: Completed
• Phase: Phase 0
• First received: December 13, 2014
• Last updated: January 7, 2015
• Start date: January 2014
• Est. completion date: August 2014

Study information

• Verified date: January 2015
• Source: Necmettin Erbakan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics CommitteeUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gingival Recession
• Gingival Recessions

Intervention

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
• 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

Locations

Country	Name	City	State
Turkey	NEU Dental School	Konya

Sponsors (1)

Lead Sponsor	Collaborator
Necmettin Erbakan University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete root coverage	Change from baseline in gingival recession will be assessed at 1, 3 and 6 months.	6 months	No
Primary	Gingival recession depth	Change from baseline in gingival recession will be assessed at 6 months	6 months	No
Secondary	Keratinized tissue width	Change from baseline in keratinized tissue at 6 months.	6 months	No
Secondary	Pain scores	Pain level evaluated on visual analog scale	first week after operations	No