Palatal Wound Healing After Free Gingival Graft Surgery

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

Study Overview

• Status: Recruiting
• Conditions: Gingival Recession, Localized; Postoperative Morbidity; Palatal Donor Site Wound Healing
• Intervention / Treatment: Drug: triamcinolone acetonide; Device: kollajen membran (Cytoplast™ RTMFOAM™, Osteogenics Biomedical Inc., Texas, ABD)

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.

• Study Type: Interventional
• Enrollment (Estimated): 55
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Esra Bozkurt; Phone Number: +905533618725; Email: dtesrabozkurt@gmail.com

Study Locations

• Turkey (Türkiye)
  • Kahramanmaraş
    • Kahramanmaraş, Kahramanmaraş, Turkey (Türkiye), 46000
      • Recruiting
      • Kahramanmaraş Sütçü İmam University
      • Contact: Esra Bozkurt; Phone Number: +905533618725; Email: dtesrabozkurt@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group; 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); 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.
Experimental: Test Group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Postoperative Days 1, 2, 3, 4, 5, 6, 7 and 14
Analgesic Consumption	The total number of analgesic tablets consumed during the first postoperative week will be recorded.	Postoperative Days 1, 2, 3, 4, 5, 6, 7 and 14

Collaborators and Investigators

• Sponsor: Kahramanmaras Sutcu Imam University

Publications and helpful links

General 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.
• 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.

Helpful Links

• Kahramanmaraş Sütçü İmam University Clinical Research Ethics Committee

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2025
• Primary Completion (Estimated): May 20, 2026
• Study Completion (Estimated): May 20, 2026

Study Registration Dates

• First Submitted: February 5, 2026
• First Submitted That Met QC Criteria: February 12, 2026
• First Posted (Actual): February 13, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Wound Healing; Triamcinolone Acetonide; Free Gingival Graft; Palatal Donor Site
• Additional Relevant MeSH Terms: Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Gingival Diseases; Gingival Recession; Polycyclic Compounds; Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Triamcinolone Acetonide
• Other Study ID Numbers: 2025/03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared in order to protect patient privacy and confidentiality, in accordance with ethical standards and institutional data protection policies.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No