Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
NCT06782035

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

Led by Izmir Katip Celebi University · Updated on 2025-01-17

36

Participants Needed

1

Research Sites

20 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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"
Not Eligible

You will not qualify if you...

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

AI-Screening

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Trial Site Locations

Total: 1 location

1

Izmir Katip Celebi University Faculty of Dentistry Department of Periodontology

Izmir, Turkey (Türkiye)

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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