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

Free Gingival Graft Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04390100
• Other study ID #: 566
• Status: Completed
• Phase: Phase 4
• Start date: February 1, 2019
• Est. completion date: February 1, 2020

Study information

• Verified date: May 2020
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 1, 2020
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Free Gingival Graft

Intervention

Drug:
• hyaluronic acid (Gengiegel 0.2% oral gel )
coverage of the free gingival graft area in the palate

Other:
• Platelet rich fibrin
coverage of the free gingival graft area in the palate
• Gel foam
coverage of the free gingival graft area in the palate

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry ,Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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