Palatal Wound Healing After Free Gingival Graft Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKahramanmaras Sutcu Imam University
About this trial
This randomized controlled clinical trial aims to evaluate the effects of topical triamcinolone acetonide application on wound healing and patient-reported outcomes at the palatal donor site following free gingival graft (FGG) surgery. A total of 55 patients with mucogingival deficiencies requiring FGG will be randomly assigned to either a control group receiving a collagen membrane or a test group receiving topical triamcinolone acetonide at the donor site. All palatal donor areas will be protected with a periodontal dressing. Clinical assessments will be performed on postoperative days 3, 7, 14, and 30. Wound epithelialization will be evaluated using the hydrogen peroxide bubbling test, while wound healing and scar formation will be assessed using the Landry, Turnbull, and Howley index and the modified Manchester Scar Scale, respectively. Patient-centered outcomes, including postoperative pain, discomfort, analgesic consumption, and oral health-related quality of life, will be assessed using visual analog scales and the Oral Health Impact Profile-14 questionnaire. The findings of this study are expected to provide evidence regarding the potential benefits of topical corticosteroid use in reducing palatal donor site morbidity following FGG surgery.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adults aged 18 years and older
Patients presenting with insufficient attached gingiva and/or gingival recession requiring free gingival graft surgery
Systemically healthy individuals (ASA I)
Full-mouth plaque score (FMPS) < 15% and full-mouth bleeding score (FMBS) < 15% at the time of surgery
Disqualifiers
Presence of systemic diseases that may affect wound healing (e.g., diabetes mellitus, immunological disorders)
Use of systemic corticosteroids, immunosuppressive drugs, or anti-inflammatory medications within the last 3 months
Current smokers or tobacco users
Pregnancy or lactation
Trial design
Design model
Parallel
Treatments tested in this trial
kollajen membran (Cytoplast™ RTMFOAM™, Osteogenics Biomedical Inc., Texas, ABD)
DeviceA kollajen membran (Cytoplast™ RTMFOAM™, Osteogenics Biomedical Inc., Texas, ABD) will be applied to the palatal donor site following free gingival graft harvesting to control bleeding and support wound healing. The donor area will be covered with sterile aluminum foil and a periodontal dressing.
triamcinolone acetonide
DrugTopical triamcinolone acetonide will be applied to the palatal donor site following free gingival graft harvesting to reduce postoperative inflammation and improve wound healing. The donor area will be covered with sterile aluminum foil and a periodontal dressing.
Treatment groups
55 Participants
are divided into 2 treatment groupsGroup A: Control GroupActive comparator 1 intervention
Group B: Test GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Oral Health-Related Quality of Life
Oral health-related quality of life was evaluated using the Oral Health Impact Profile-14 questionnaire. The scale consists of 14 items scored on a 5-point Likert scale ranging from 0 (never) to 4 (very often). Total scores range from 0 to 56, with higher scores indicating poorer oral health-related quality of life.
Time frame
Postoperative Days 3, 7, 14, and 302
Number of participants with complete wound epithelialization
Epithelialization of the palatal donor site will be evaluated using the hydrogen peroxide (H₂O₂) bubbling test. The presence of bubbling will be recorded as absence of epithelialization, whereas the absence of bubbling will indicate complete epithelialization.
Time frame
Postoperative Days 3, 7, 14, and 303
Wound Healing at the Palatal Donor Site
Soft tissue healing was assessed using the Landry, Turnbull, and Howley Healing Index . The index is scored on a 5-point scale ranging from 1 to 5, where higher scores indicate better wound healing.
Time frame
Postoperative Days 3, 7, 14, and 304
Scar Formation
Scar formation at the palatal donor site, including color match, contour, and tissue deformity, will be evaluated using the Modified Manchester Scar Scale, which is scored on a scale ranging from 0 to 4, where higher scores indicate poorer scar outcomes.
Time frame
Postoperative Days 3, 7, 14, and 30Secondary outcomes
1
Postoperative Pain and Discomfort
Postoperative pain, discomfort, bleeding, and changes in dietary habits will be evaluated using a 0-10 visual analog scale (VAS) completed by the participants.
Time frame
Postoperative Days 1, 2, 3, 4, 5, 6, 7 and 142
Analgesic Consumption
The total number of analgesic tablets consumed during the first postoperative week will be recorded.
Time frame
Postoperative Days 1, 2, 3, 4, 5, 6, 7 and 14Sponsors and contacts
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Source ClinicalTrials.gov