Palatal Wound Healing After Free Gingival Graft Surgery

Official title

Impact of Topical Triamcinolone Acetonide on Palatal Wound Healing, Patient Morbidity, and Quality of Life After Free Gingival Graft Surgery: A Randomized Clinical Trial

Overview

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.

Detailed description

Free gingival graft (FGG) surgery is widely used in periodontal plastic surgery to increase the width of keratinized gingiva and to treat mucogingival defects around teeth and dental implants. The palatal mucosa is considered the preferred donor site for FGG procedures due to its favorable anatomical characteristics and adequate tissue thickness. However, harvesting a free gingival graft results in a secondary-intention wound at the palatal donor site, which is commonly associated with postoperative pain, discomfort, bleeding, and delayed wound healing, adversely affecting patient compliance and quality of life.

Various biomaterials and therapeutic approaches have been proposed to reduce palatal donor site morbidity and to promote wound healing following FGG surgery, including collagen-based materials, platelet concentrates, low-level laser therapy, ozone therapy, and topical agents. Corticosteroids are potent anti-inflammatory drugs that inhibit the arachidonic acid pathway, reduce capillary permeability, suppress fibroblast proliferation, and decrease the production of inflammatory mediators, thereby contributing to reduced postoperative inflammation and pain. Triamcinolone acetonide, a corticosteroid commonly used in oral medicine, has demonstrated beneficial effects in the management of oral ulcerative and inflammatory lesions. However, to the best of our knowledge, there is no clinical study evaluating the effects of topical triamcinolone acetonide application on palatal donor site wound healing following FGG surgery.

This randomized controlled clinical trial will include 55 systemically healthy patients presenting with insufficient attached gingiva and/or gingival recession, for whom FGG surgery is indicated. Participants will be randomly allocated into two groups. In the control group, a collagen hemostatic absorbable sponge will be applied to the palatal donor site following graft harvesting. In the test group, topical triamcinolone acetonide will be applied to the palatal donor site. In both groups, the donor area will be covered with sterile aluminum foil and a periodontal dressing to standardize wound protection.

All surgical procedures will be performed by a single experienced clinician to ensure procedural consistency. Postoperative evaluations will be conducted on days 3, 7, 14, and 30. Wound epithelialization will be assessed using the hydrogen peroxide (H₂O₂) bubbling test. Wound healing quality will be evaluated using the Landry, Turnbull, and Howley healing index, and scar formation will be assessed using the modified Manchester Scar Scale. Patient-reported outcomes, including postoperative pain, discomfort, bleeding, changes in dietary habits, and analgesic consumption, will be recorded using visual analog scales. Oral health-related quality of life will be assessed using the Oral Health Impact Profile-14 (OHIP-14) questionnaire.

The results of this study are expected to clarify the potential role of topical triamcinolone acetonide in enhancing wound healing and reducing patient morbidity at the palatal donor site following free gingival graft surgery, thereby contributing to evidence-based clinical decision-making in periodontal plastic surgery.

Interventions

• Device kollajen membran (Cytoplast™ RTMFOAM™, Osteogenics Biomedical Inc., Texas, ABD)
  A 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.
• Drug triamcinolone acetonide
  Topical 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.

Primary outcome measures

• Oral Health-Related Quality of Life [Time frame: Postoperative Days 3, 7, 14, and 30]
• Number of participants with complete wound epithelialization [Time frame: Postoperative Days 3, 7, 14, and 30]
• Wound Healing at the Palatal Donor Site [Time frame: Postoperative Days 3, 7, 14, and 30]
• Scar Formation [Time frame: Postoperative Days 3, 7, 14, and 30]

Secondary outcome measures (2)

• Postoperative Pain and Discomfort [Time frame: Postoperative Days 1, 2, 3, 4, 5, 6, 7 and 14]
• Analgesic Consumption [Time frame: Postoperative Days 1, 2, 3, 4, 5, 6, 7 and 14]

Eligibility criteria

Inclusion criteria

• 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
• Ability and willingness to provide written informed consent and comply with study procedures

Exclusion criteria

• 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
• History of periodontal surgery at the palatal donor site
• Presence of active infection, ulceration, or pathological lesions at the palatal donor area
• Known allergy or hypersensitivity to corticosteroids, collagen materials, or study-related medications

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Kahramanmaraş Sütçü İmam University — Kahramanmaraş

Publications

• Murugan AJ, Ganesan A, Aniyan YK, Lakshmi KC, Asokan K. Comparison of topical purslane & topical 0.1% triamcinolone acetonide in the management of oral lichen planus - a double blinded clinical trial. BMC Oral Health. 2023 Sep 19;23(1):678. doi: 10.1186/s12903-023-03385-1. PMID 37726676
• Siponen M, Huuskonen L, Kallio-Pulkkinen S, Nieminen P, Salo T. Topical tacrolimus, triamcinolone acetonide, and placebo in oral lichen planus: a pilot randomized controlled trial. Oral Dis. 2017 Jul;23(5):660-668. doi: 10.1111/odi.12653. Epub 2017 Mar 31. PMID 28168769

Identifiers

NCT: NCT07409571 · 2025/03

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗