The Influence of Periodontal Dressings (Ora-Aid) and Various Materials on the Donor Site's Quality of Life After Free Gingival Graft Surgery

Status: Recruiting
Location: See location...
Intervention Type: Biological, Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• Systemically healthy Non-smoker Insufficient attached gingiva Not using any medication regularly Age 18-85 years No previous graft taken from the same area Not in pregnancy or lactation period Agreement to participate in the study and sign the Informed Consent Form

Locations
Other Locations
Turkey
Izmir Katip Celebi University Faculty of Dentistry Department of Periodontology
RECRUITING
Izmir
Time Frame
Start Date: 2025-01-02
Estimated Completion Date: 2025-05-25
Participants
Target number of participants: 36
Treatments
Experimental: Ora-Aid
For the test group, Ora-Aid® measuring 25 mm x 15 mm is used. After achieving hemostasis and irrigating the wound area on the palate with sterile saline, Ora-Aid® is cut to appropriate dimensions to fully cover the wound site. Using tweezers, it is separated from its transparent film layer and applied to the wound. Gentle pressure is applied for 5-10 seconds until the dressing adheres to the wound site. To enhance the stabilization of Ora-Aid® in the area, it is secured using 4/0 silk sutures with a cross-suture technique.
Active_comparator: L-PRF
For the L-PRF group, venous blood is collected from patients using a disposable sterile syringe and placed into glass tubes without anticoagulants. The blood samples are centrifuged at 2700 rpm for 12 minutes in a centrifuge device. After the centrifugation process is completed, the clot formed in the middle layer of the tube is removed using tweezers and placed between two sterile metal plates to be compressed into a membrane. The dimensions of the obtained L-PRF membrane are adjusted according to the size of the donor site. The wound area on the palate is sutured crosswise using 4/0 silk suture material, and the L-PRF membrane is placed on the wound surface.
Active_comparator: Palatal Stent
For the palatal stent group, impressions are taken from patients preoperatively, and a plate is prepared. The fit of the plate is checked in the oral cavity. After the free gingival graft is harvested, hemostasis is achieved at the wound site, and the palatal stent is placed on the maxilla.
Related Therapeutic Areas
Sponsors
Leads: Izmir Katip Celebi University

This content was sourced from clinicaltrials.gov

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