Gingival Recession, LocalizedNCT07409571
Palatal Wound Healing After Free Gingival Graft Surgery
A study testing kollajen membran (Cytoplast™ RTMFOAM™, Osteogenics Biomedical Inc., Texas, ABD) and triamcinolone acetonide in people with Gingival Recession, Localized and Postoperative Morbidity, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession, Localized, Postoperative Morbidity, Palatal Donor Site Wound Healing
- What is being tested?
- kollajen membran (Cytoplast™ RTMFOAM™, Osteogenics Biomedical Inc., Texas, ABD) and triamcinolone acetonide
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Oct 2025to 20 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kahramanmaraş Sütçü İmam University
Kahramanmaraş, Kahramanmaraş, 46000
Esra Bozkurt, +905533618725, dtesrabozkurt@gmail.com
About this study
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
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.
Read the 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.
- Being tested
- kollajen membran (Cytoplast™ RTMFOAM™, Osteogenics Biomedical Inc., Texas, ABD), triamcinolone acetonide
- Keywords
- Free Gingival Graft, Palatal Donor Site, Wound Healing, Triamcinolone Acetonide
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
triamcinolone acetonideDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Drug: triamcinolone acetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Postoperative Days 3, 7, 14, and 30
Secondary outcomes (2)
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.
Measured: 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.
Measured: Postoperative Days 1, 2, 3, 4, 5, 6, 7 and 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start16 Oct 2025
- Primary completion20 May 2026 (estimated)
- Study completion20 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gingival Recession, LocalizedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Bozkurt, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07409571
- Sponsor's protocol ID
- 2025/03
- Status last verified
- Feb 2026
- First submitted
- 5 Feb 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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.
PubMed 37726676Siponen 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.
PubMed 28168769
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07409571
- Acronym / sponsor ID
- 2025/03
- Keywords
- Free Gingival Graft, Palatal Donor Site, Wound Healing, Triamcinolone Acetonide
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 16 Oct 2025 (actual)
- Primary completion
- 20 May 2026 (estimated)
- Study completion
- 20 May 2026 (estimated)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Device: kollajen membran (Cytoplast™ RTMFOAM™, Osteogenics Biomedical Inc., Texas, ABD)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 |
| Test Group | Experimental | Drug: triamcinolone acetonideParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Control Group |
| triamcinolone acetonideTopical 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. | Drug | Test Group |
Primary outcome
Oral Health-Related Quality of Life
Time frame: Postoperative Days 3, 7, 14, and 30
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.
Number of participants with complete wound epithelialization
Time frame: Postoperative Days 3, 7, 14, and 30
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.
Wound Healing at the Palatal Donor Site
Time frame: Postoperative Days 3, 7, 14, and 30
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.
Scar Formation
Time frame: Postoperative Days 3, 7, 14, and 30
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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Results publication: PubMed 37726676Murugan 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.
- Results publication: PubMed 28168769Siponen 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.
- Kahramanmaraş Sütçü İmam University Clinical Research Ethics CommitteeLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing kollajen membran (Cytoplast™ RTMFOAM™, Osteogenics Biomedical Inc., Texas, ABD) and triamcinolone acetonide in people with Gingival Recession, Localized and Postoperative Morbidity, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact esra bozkurt (+905533618725, dtesrabozkurt@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral Health-Related Quality of Life (time frame: Postoperative Days 3, 7, 14, and 30). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07409571, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.