Palatal Wound Healing Evaluation After Application of Platelet Rich Fibrin Versus 0.2% Hyaluronic Acid Dressings

Palatal Wound Healing Evaluation After Application of Platelet Rich Fibrin Versus 0.2% Hyaluronic Acid Dressings (Randomized Controlled Clinical Trial)

Free gingival graft (FGG) was first proposed by Bjorn 1963 and Nabers 1966. FGG is indicated to correct mucogingival problems such as inadequate or lack of attached gingiva and gingival recession. The most frequent donor site for free gingival graft is the palate

Although, great concern has been given to the recipient sites by using different techniques as suturing, tissue adhesives and special dressings, a little attention was given to protect the donor sites after free gingival graft harvesting. The palatal donor site heal by secondary intention, it could take around 2 to 4 weeks depending on the width and thickness of the tissue removed.The common clinical events that occurs following FGG procedure are patient's discomfort, pain and bleeding at the donor site.

Study Overview

• Status: Completed
• Conditions: Free Gingival Graft
• Intervention / Treatment: Other: Platelet rich fibrin; Drug: hyaluronic acid (Gengiegel 0.2% oral gel ); Other: Gel foam

Detailed Description

In an attempt to protect the plate (donor site) so that it could help in decreasing the patient's post operative pain, Farnoush suggested variant clinical techniques. One of these techniques was interproximal wire ligation by placing a stainless steel wire anchored on the teeth stabilizing the periodontal dressing. He also suggested using a modified Hawley appliance which would act as a palatal stent protecting the palate to help in healing.

After periodontal surgeries, the donor site (palate) has to be protected from the external environment by many dressing materials. Conventional periodontal dressings provide an inert barrier that help healing by preventing the external insults on the wound area. However, these dressings do not affect the cellular behavior and do not display a role in the biological events that happen during wound healing.

Platelet-rich fibrin (PRF) is a simple procedure where patient's own blood is collected and centrifuged. PRF clot forms a strong fibrin matrix that can be compressed to form a membrane. PRF membrane consists of a fibrin 3D mesh polymerized in a specific structure that incorporates platelets, leukocytes, growth factors; and the circulating stem cells.PRF membrane enhance angiogenesis, immunity and wound epithelialisation. Thus, based on such findings the PRF membrane can be used as a palatal dressing

PRF membrane enhances the healing of the donor site (palate).According to Shakir et al., complete epithelialisation of the palatal donor site was reached by 18th day after FGG in the groups where PRF membranes was placed with less pain scores on the 2nd and 7th day than the control group. Therefore PRF membranes showed higher capabilities of the donor site healing stimulation.

Hyaluronic acid (HA) is a high molecular weight, non-sulphated polysaccharide component of the family of the glycosaminoglycanes,it is present in various body fluids such as synovial fluid, serum, saliva and gingival crevicular fluid. In addition, it represents an important component of the extracellular matrix of skin, connective tissue, synovial joints and other tissues. HA is identified in all periodontal tissues, being prominent in the non-mineralized tissues such as gingiva and periodontal ligament, and in low quantities in mineralized tissues such as cementum and alveolar bone.

Hyaluronic acid has been suggested as monotherapy or as an adjunct to non-surgical and/or surgical periodontal treatment to reduce inflammation and promote wound healing. Hyaluronic acid can be used to accelerate the palatal wound healing at the donor site after free gingival graft surgery

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 1113311
    • Faculty of Dentistry ,Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients who are indicated for soft tissue augmentation with free gingival graft for mucogingival surgery or for implant therapy
• Good patient compliance with the plaque control instructions following initial therapy.

Exclusion Criteria:

• Presence of systemic diseases which could influence the outcome of the therapy
• Smoker patients.
• Pregnant females
• Vulnerable group of patients (prisoners ,handicapped, decisionally impaired individuals)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: PRF; PRF membrane is placed in the area where the free gingival graft was taken from the palate	Other: Platelet rich fibrin; coverage of the free gingival graft area in the palate; Other Names: PRF
ACTIVE_COMPARATOR: hyaluronic acid; hyaluronic acid gel is placed in the area where the free gingival graft was taken from the palate and the patient is instructed to place the gel 3 times per day	Drug: hyaluronic acid (Gengiegel 0.2% oral gel ); coverage of the free gingival graft area in the palate; Other Names: Platelet rich fibrin (PRF)
ACTIVE_COMPARATOR: Gel foam; Gel foam is placed in the area where the free gingival graft was taken from the palate	Other: Gel foam; coverage of the free gingival graft area in the palate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual analogue scale(VAS)	evaluate of the pain at 3,7,14,21 and 30 with score staring from 0 (minimal pain) to 10(maximum pain) after the application of Platelet rich fibrin and hyaluronic acid and gel foam as a palatal dressing after harvesting a free gingival graft from the palate (donor site)	one month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
assessment of healing using the healing index scale by Landry et al1984	evaluate the palatal healing at 7,14 21 and 30 days with scale starting from (1 for very poor healing and 5 excellent healing) following free gingival graft harvesting using Platelet rich fibrin and hyaluronic acid.	one month

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Director: Ahmed abdel aziz hassan, Associate Professor, Faculty of Dentistry Ain Shams University

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2019
• Primary Completion (ACTUAL): December 1, 2019
• Study Completion (ACTUAL): February 1, 2020

Study Registration Dates

• First Submitted: May 9, 2020
• First Submitted That Met QC Criteria: May 13, 2020
• First Posted (ACTUAL): May 15, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 15, 2020
• Last Update Submitted That Met QC Criteria: May 13, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Hemostatics; Coagulants; Viscosupplements; Hyaluronic Acid; Gelatin Sponge, Absorbable
• Other Study ID Numbers: 566

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: sharing of the study methodology and the clinical results
• IPD Sharing Time Frame: the data will be available for a year from it's submission date
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

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