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

NCT ID: NCT04390100

Last Updated: 2020-05-15

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

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2020-02-01

Brief Summary

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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.

Detailed Description

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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

Conditions

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Free Gingival Graft

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

3 groups each receiving a different type of intervention
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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PRF

PRF membrane is placed in the area where the free gingival graft was taken from the palate

Group Type ACTIVE_COMPARATOR

Platelet rich fibrin

Intervention Type OTHER

coverage of the free gingival graft area in the palate

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

Group Type ACTIVE_COMPARATOR

hyaluronic acid (Gengiegel 0.2% oral gel )

Intervention Type DRUG

coverage of the free gingival graft area in the palate

Gel foam

Gel foam is placed in the area where the free gingival graft was taken from the palate

Group Type ACTIVE_COMPARATOR

Gel foam

Intervention Type OTHER

coverage of the free gingival graft area in the palate

Interventions

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hyaluronic acid (Gengiegel 0.2% oral gel )

coverage of the free gingival graft area in the palate

Intervention Type DRUG

Platelet rich fibrin

coverage of the free gingival graft area in the palate

Intervention Type OTHER

Gel foam

coverage of the free gingival graft area in the palate

Intervention Type OTHER

Other Intervention Names

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Platelet rich fibrin (PRF) PRF

Eligibility Criteria

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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)
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Nourhan Alaa el din Akl

principal investigator(teaching assistant)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed abdel aziz hassan, Associate Professor

Role: STUDY_DIRECTOR

faculty of dentistry ain shams university

Locations

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Faculty of Dentistry ,Ain Shams University

Cairo, , Egypt

Site Status

Countries

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Egypt

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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566

Identifier Type: -

Identifier Source: org_study_id

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