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

NCT06782035 | Recruiting FDA Device

• 1 other identifier: E-61749811-000-3341706
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Free gingival graft; Mucogingival surgery; Periodontal dressing

Outcome Measures

Primary Outcomes (2)

• "Patient Satisfaction Data Assessed with the Oral Health Impact Profile-14 (OHIP-14) Questionnaire"

  In our study, the OHIP-14 questionnaire was used to evaluate patient satisfaction on postoperative days 3, 7, and 14. The OHIP-14 questionnaire comprises 14 questions (S1-S14) related to functional limitation (S1-S2), physical pain (S3-S4), psychological discomfort (S5-S6), physical disability (S7-S8), psychological disability (S9-S10), social disability (S11-S12), and handicap (S13-S14). Each question was scored on a 5-point Likert scale.

  Postoperative days 3, 7, and 14

• Use of Visual Analog Scale (VAS) for Pain Measurements

  The Visual Analog Scale (VAS) test is used to measure pain levels in patients on postoperative days 3, 7, and 14. For VAS scoring, patients are asked to mark an integer value between 0 and 10.

  Postoperative days 3, 7, and 14

Secondary Outcomes (1)

• Hydrogen Peroxide Test for the Presence of Epithelialization

  Postoperative day 7, day 14, and month 1.

Study Arms (3)

Ora-Aid

EXPERIMENTAL

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.

Device: Ora-Aid-Oral Wound Dressing

L-PRF

ACTIVE COMPARATOR

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.

Biological: Platelet rich fibrin

Palatal Stent

ACTIVE COMPARATOR

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.

Device: Palatal Stent

Interventions

Ora-Aid-Oral Wound Dressing DEVICE

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.

Ora-Aid

Platelet rich fibrin BIOLOGICAL

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.

L-PRF

Palatal Stent DEVICE

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.

Palatal Stent

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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"

You may not qualify if:

• Systemic disease Regular systemic medication use Under 18 years old Pregnant or breastfeeding women Smoker Previous graft taken from the same area

Sponsors & Collaborators

• Izmir Katip Celebi University: lead

Study Sites (1)

Izmir Katip Celebi University Faculty of Dentistry Department of Periodontology

Izmir, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The person assessing epithelialization does not know the group distribution.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: After free gingival graft surgery, different materials were applied to aid healing due to the discomfort and pain caused by the wound in the palatal donor site during the postoperative healing process. A total of 36 patients were included in the study and divided into three groups based on the material applied. The test group consisted of "Ora-Aid," while the control groups included L-PRF and the palatal stent group, with 12 patients in each group.In our study, the OHIP-14 questionnaire was used to evaluate patient satisfaction on postoperative days 3, 7, and 14. To measure pain levels on postoperative days 3, 7, and 14, the Visual Analog Scale (VAS) test was used. For VAS scoring, patients were asked to mark an integer value between 0 and 10. Wound epithelialization was assessed on days 7, 14, and 1 month postoperatively as either "present" or "absent."

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 17, 2025
• Study Start: January 2, 2025
• Primary Completion: March 30, 2025
• Study Completion: May 25, 2025
• Last Updated: January 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)