Palatal Wound Healing After Free Gingival Graft Surgery

NCT07409571 | Recruiting

• 1 other identifier: 2025/03
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gingival Recession, Localized; Postoperative Morbidity; Palatal Donor Site Wound Healing

Keywords

Free Gingival Graft; Palatal Donor Site; Wound Healing; Triamcinolone Acetonide

Outcome Measures

Primary Outcomes (4)

• 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.

  Postoperative Days 3, 7, 14, and 30

• 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.

  Postoperative Days 3, 7, 14, and 30

• 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.

  Postoperative Days 3, 7, 14, and 30

• 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.

  Postoperative Days 3, 7, 14, and 30

Secondary Outcomes (2)

• Postoperative Pain and Discomfort

  Postoperative Days 1, 2, 3, 4, 5, 6, 7 and 14

• Analgesic Consumption

  Postoperative Days 1, 2, 3, 4, 5, 6, 7 and 14

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Participants in this group will undergo free gingival graft surgery. Following graft harvesting, a kollajen membran (Cytoplast™ RTMFOAM™, Osteogenics Biomedical Inc., Texas, ABD) will be applied to the palatal donor site

Device: kollajen membran (Cytoplast™ RTMFOAM™, Osteogenics Biomedical Inc., Texas, ABD)

Test Group

EXPERIMENTAL

Participants in this group will receive a free gum graft procedure. After the graft is harvested, topical triamcinolone acetonide will be applied to the palatal donor area, and a collagen membrane (Cytoplast™ RTMFOAM™, Osteogenics Biomedical Inc., Texas, USA) will be placed over it.

Drug: triamcinolone acetonide

Interventions

kollajen membran (Cytoplast™ RTMFOAM™, Osteogenics Biomedical Inc., Texas, ABD) DEVICE

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.

Control Group

triamcinolone acetonide DRUG

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.

Test Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kahramanmaras Sutcu Imam University: lead

Study Sites (1)

Kahramanmaraş Sütçü İmam University

Kahramanmaraş, Kahramanmaraş, 46000, Turkey (Türkiye)

RECRUITING

Related Publications (2)

• 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 RESULT

• 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 RESULT

Related Links

• Kahramanmaraş Sütçü İmam University Clinical Research Ethics Committee

MeSH Terms

Conditions

Gingival Recession

Interventions

Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

esra bozkurt

CONTACT

+905533618725; dtesrabozkurt@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: February 13, 2026
• Study Start: October 16, 2025
• Primary Completion: May 20, 2026
• Study Completion: May 20, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)