PRF for Accelerating Palatal Healing

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2015-09-30

Brief Summary

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Backgroung: Various agents are used to reduce post-operative complications associated with palatal donor site surgery for free gingival graft (FGG) harvesting. This study was conducted to evaluate the effects of platelet-rich fibrin (PRF) on palatal wound healing.

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Detailed Description

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125 patients with isolated recessions were treated. The connective tissue graft was obtained by the de-epithelialization of a free gingival graft in both groups. Three different hemostatic treatments were randomized; PRF with cyanoacrilate adhesive (PRF group, n:42), cyanoacrilate adhesive alone (BC group, n:42) and sterile wet gauze compression (WG group, n:41). Immediate and delayed bleeding, pain, epithelialization, feeding habits and sensation scores were recorded for different time points.

Conditions

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Gingival Recession

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Platelet Rich Fibrin

PRF was laid directly on the palatal wound immediately after harvesting the tissue graft and stabilized

Group Type EXPERIMENTAL

Platelet Rich Fibrin

Intervention Type OTHER

Immediate and delayed bleeding, pain, epithelialization, feeding habits and sensation scores were recorded after PRF placing on palatal wounds.

Butyl cyanoacrylate

Butyl cyanoacrylate was directly applied on the palatal wound after harvesting the tissue graft

Group Type ACTIVE_COMPARATOR

Butyl cyanoacrylate

Intervention Type OTHER

Immediate and delayed bleeding, pain, epithelialization, feeding habits and sensation scores were recorded after Butyl Cyanoacrylate application on palatal wounds.

Wet Gauze

Wet Gauze was placed for 1 minute on the palatal wound after harvesting the tissue graft

Group Type PLACEBO_COMPARATOR

Wet gauze

Intervention Type OTHER

Immediate and delayed bleeding, pain, epithelialization, feeding habits and sensation scores were recorded after wet gauze pressure on palatal wounds.

Interventions

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Platelet Rich Fibrin

Immediate and delayed bleeding, pain, epithelialization, feeding habits and sensation scores were recorded after PRF placing on palatal wounds.

Intervention Type OTHER

Butyl cyanoacrylate

Immediate and delayed bleeding, pain, epithelialization, feeding habits and sensation scores were recorded after Butyl Cyanoacrylate application on palatal wounds.

Intervention Type OTHER

Wet gauze

Immediate and delayed bleeding, pain, epithelialization, feeding habits and sensation scores were recorded after wet gauze pressure on palatal wounds.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* no contraindications for periodontal surgery;
* full-mouth plaque score of \<10%
* full-mouth bleeding score of \<15%.

Exclusion Criteria

* previously undergone surgery for a graft harvested from the palate
* presence of systemic disease or taking medication known to interfere with periodontal health
* smokers
* possible coagulation disorders

Minimum Eligible Age

21 Years

Maximum Eligible Age

48 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes