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

NCT04390100 | Completed Phase 4 DMC

• 1 other identifier: 566
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Free Gingival Graft

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• assessment of healing using the healing index scale by Landry et al1984

  one month

Study Arms (3)

PRF

ACTIVE COMPARATOR

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

Other: Platelet rich fibrin

hyaluronic acid

ACTIVE COMPARATOR

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 )

Gel foam

ACTIVE COMPARATOR

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

Other: Gel foam

Interventions

hyaluronic acid (Gengiegel 0.2% oral gel ) DRUG

coverage of the free gingival graft area in the palate

Also known as: Platelet rich fibrin (PRF)

hyaluronic acid

Platelet rich fibrin OTHER

coverage of the free gingival graft area in the palate

Also known as: PRF

PRF

Gel foam OTHER

coverage of the free gingival graft area in the palate

Gel foam

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Dentistry ,Ain Shams University

Cairo, 1113311, Egypt

Location

MeSH Terms

Interventions

Hyaluronic Acid; Gels; Vaginal Creams, Foams, and Jellies

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations; Feminine Hygiene Products; Equipment and Supplies

Study Officials

• Ahmed abdel aziz hassan, Associate Professor

  faculty of dentistry ain shams university

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator(teaching assistant)

Model Details: 3 groups each receiving a different type of intervention

Study Record Dates

• First Submitted: May 9, 2020
• First Posted: May 15, 2020
• Study Start: February 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: February 1, 2020
• Last Updated: May 15, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: the data will be available for a year from it's submission date

Locations

EG (1)