Evaluation of the Effects of Platelet Rich Fibrin on the Palatal Mucosal 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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-30

Study Completion Date

2018-11-01

Brief Summary

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Subepithelial connective tissue graft (SCTG) has greater predictability for root coverage and causes minimal discomfort to patient. Although donor site heals with primary intention causing less scar tissue, in some different harvesting procedures primary flap closure may not be achieved due to nature of thick palatal tissues. Some potential complications may occur at donor site such as: necrosis of graft and palatal site, pain, excessive hemorrhage, protracted discomfort, donor site infection and in some cases donor site paresthesia. Platelet rich fibrin (PRF) is a platelet concentrate obtained by a simple procedure that does not require biochemical blood involvement.Based on the known biological effects of PRF, the aim of this study is to evaluate the PRF in the management of soft tissue donor sites in term of bleeding and pain sensation, and to observe the changes in tissue healing after a subepithelial connective tissue graft procedure at palatal donor site.

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Detailed Description

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Successful treatment of gingival recession (GR) is based on the use of clinically predictable periodontal plastic surgery (PPS) procedures. There are many procedures and different surgical procedures were proposed. Coronally advanced flap and subepithelial connective tissue graft (SCTG) is a good combination to increase the keratinized tissue width and reduce the amount of gingival recession.

SCTG has greater predictability for root coverage and causes minimal discomfort to patient. Although donor site heals with primary intention causing less scar tissue, in some different harvesting procedures primary flap closure may not be achieved due to nature of thick palatal tissues.

Some potential complications may occur at donor site such as: necrosis of graft and palatal site, pain, excessive hemorrhage, protracted discomfort, donor site infection and in some cases donor site paresthesia.

Platelet rich fibrin (PRF) is a platelet concentrate obtained by a simple procedure that does not require biochemical blood involvement. The three-dimensional fibrin network and presence of many growth factors such as fibroblast growth factor, platelet-derived growth factor (PDGF) and epidermal growth factor supports effective neovascularization, accelerated wound closure and rapid cicatricial tissue remodeling. The strong fibrin architecture distinguishes it from other kinds of platelets concentrates and it seems responsible for the slow release of growth factors over a period of 7-14 days5. This period is seen as sufficient to prevent complications after connective tissue graft. Since the first description by Choukroun in 2000, PRF has been used in the clinical field for more than a decade in oral surgery and implant dentistry.

Based on the known biological effects of PRF, the aim of this study is to evaluate the PRF in the management of soft tissue donor sites in term of bleeding and pain sensation, and to observe the changes in tissue healing after connective tissue graft procedure at palatal donor site.

Conditions

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Wound Healing Pain, Postoperative Bleeding Wound

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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connective tissue graft

Drug:local anesthesia (2% lidocaine with 1:100,000 epinephrine/ultracaine ds ampule)

Other names:

* 5/0 silk suture

Group Type ACTIVE_COMPARATOR

connective tissue graft

Intervention Type PROCEDURE

* anesthesia of the palatal mucosa
* subepithelial connective tissue graft harvesting
* suturing (5/0 silk suture)

connective tissue graft&PRF

Intervention Type PROCEDURE

anesthesia of the palatal mucosa subepithelial connective tissue graft harvesting

-suturing (5/0 silk suture)

connective tissue graft&PRF

Intervention Type OTHER

* taking blood from patient
* centrifuging blood
* obtain PRF

connective tissue graft&PRF

Drug: local anesthesia (2% lidocaine with 1:100,000 epinephrine/ultracaine ds ampule)

Other names:

-5/0 silk suture

Group Type EXPERIMENTAL

connective tissue graft

Intervention Type PROCEDURE

* anesthesia of the palatal mucosa
* subepithelial connective tissue graft harvesting
* suturing (5/0 silk suture)

connective tissue graft&PRF

Intervention Type PROCEDURE

anesthesia of the palatal mucosa subepithelial connective tissue graft harvesting

-suturing (5/0 silk suture)

connective tissue graft&PRF

Intervention Type OTHER

* taking blood from patient
* centrifuging blood
* obtain PRF

Interventions

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connective tissue graft

* anesthesia of the palatal mucosa
* subepithelial connective tissue graft harvesting
* suturing (5/0 silk suture)

Intervention Type PROCEDURE

connective tissue graft&PRF

anesthesia of the palatal mucosa subepithelial connective tissue graft harvesting

-suturing (5/0 silk suture)

Intervention Type PROCEDURE

connective tissue graft&PRF

* taking blood from patient
* centrifuging blood
* obtain PRF

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* who needed connective tissue graft for treating gingival recessions were included

Exclusion Criteria

* Patients with systemic disorders (immunologic diseases, uncontrolled diabetes mellitus, ongoing chemotherapy or radiotherapy),
* smoking,
* nausea
* pregnancy/lactation

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes