The Effect of Periodontal Dressings and Various Materials on the Donor Site's Quality of Life After Free Gingival Graft Surgery

Summary

The inadequate width of attached gingiva, resulting from the loss of the attached gingiva band, is one of the primary mucogingival issues. Free gingival graft (FGG) is a mucogingival surgical technique used to increase the amount of attached gingiva, cover exposed root surfaces in localized gingival recessions, deepen the vestibule, and eliminate frenulum and muscle attachments. The harvested tissue is keratinized attached gingiva. Due to ease of access, the palate is most commonly preferred as the donor site.

Complications that may arise following FGG surgery are generally donor site-related. Reported complications include postoperative bleeding, recurrent herpetic lesions, delayed healing, paresthesia, mucocele, arteriovenous shunt, and postoperative pain. To aid healing and reduce discomfort and pain associated with the wound site in the palate after surgery, various materials have been applied to the donor site to facilitate recovery.

Following FGG surgery, patients will be divided into three groups based on the application of different materials to the wound site in the palate: leukocyte- and platelet-rich fibrin (L-PRF), Ora-Aid oral wound dressing, and a palatal surgical stent. In the Ora-Aid group, after harvesting the graft and placing it in the recipient site, the wound area will be irrigated with saline solution, and Ora-Aid will be trimmed to the appropriate size and shape. It will be gently pressed onto the wound for 5-10 seconds until it adheres. Ora-Aid and L-PRF will be secured to the wound site with a 4/0 silk cross suture. The Ora-Aid application will serve as the test group, the L-PRF application as the positive control group, and the palatal surgical stent as the negative control group. Randomization will be performed using a computer program.

Postoperatively, patients' pain levels will be assessed on the 3rd, 7th, and 14th days using the Visual Analog Scale (VAS) test and the OHIP-14 questionnaire. Wound site epithelialization will be evaluated during follow-up sessions on the 7th and 14th days and at 1 month. After evaluating all questionnaire results, statistical analyses will be conducted.

Conditions

• Recession, Gingival

Interventions

DEVICE

Ora-Aid-Oral Wound Dressing

Intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief. This product is a non-eugenol protective material applied to intraoral wounds. Ora-Aid is a new concept of pasting intra-oral patch to protect the affected area such as post implant, extraction, orthodontic, and ulcers. This new concept of pasting intra-oral wound dressing is designed to protect the affected area and aid natural healing.

BIOLOGICAL

Platelet rich fibrin

It has been reported that the use of Platelet-Rich Fibrin (PRF) to cover palatal wounds accelerates healing and reduces postoperative morbidity. Studies have demonstrated that PRF supports key processes in wound healing, such as "immunity," "angiogenesis," and "cellular proliferation." Its use has garnered significant interest, particularly in non-healing wounds and areas left to heal by secondary intention after surgery. Leukocyte and Platelet-Rich Fibrin (L-PRF) is frequently used in periodontal surgical applications. The platelets and growth factors it contains accelerate the healing process and facilitate tissue repair.

DEVICE

Palatal Stent

Palatal stents help prevent complications such as infection or excessive discomfort. These plates are typically customized to fit the patient's palate by taking impressions before the surgery. Once placed, they serve as a barrier, especially during the early stages of healing. Additionally, they may reduce the need for postoperative interventions, such as the use of strong painkillers.

Sponsors & Collaborators

• Izmir Katip Celebi University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-01-02

Primary Completion

2025-03-30

Completion

2025-05-25

FDA Device

Yes

Countries

• Turkey (Türkiye)

Study Locations