An interventional study of Curcumin and and triamcinolone acetonide and Triamcinolone Acetonide in Oral Submucous Fibrosis, sponsored by Liaquat College of Medicine and Dentistry. Completed at 1 site in Pakistan. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Liaquat College of Medicine and Dentistry · Not applicable, Interventional, and Treatment
This study evaluates whether combining oral curcumin (a natural compound derived from turmeric) with a topical steroid is more effective than using a topical steroid alone in treating Oral Submucous Fibrosis (OSMF).
OSMF is a chronic mouth condition that can cause burning, tissue stiffness, and difficulty opening the mouth, affecting eating, speaking, and oral hygiene.
Eligible participants will be randomly assigned to one of two groups:
Group A: Curcumin 500 mg twice daily + 0.1% triamcinolone acetonide ointment three times daily.
Group B: 0.1% triamcinolone acetonide ointment alone, three times daily.
Participants will be followed for six months, with assessments at baseline, 1, 3, and 6 months. Mouth opening and burning sensation will be measured.
Participation is voluntary, and all personal information will remain confidential. Participants may withdraw at any time without affecting their medical care. The study aims to determine whether the combination treatment improves mouth opening and reduces burning sensation more effectively.
Oral Submucous Fibrosis (OSMF) is a chronic, progressive, potentially malignant disorder characterized by fibrosis of the oral mucosa and restricted mouth opening. Curcumin, a bioactive polyphenolic compound derived from Curcuma longa, has demonstrated anti-inflammatory, antioxidant, and potential antifibrotic properties. Topical triamcinolone acetonide is used to manage inflammatory symptoms associated with OSMF. This study will evaluate whether adding oral curcumin to topical triamcinolone acetonide improves clinical outcomes compared with topical triamcinolone acetonide alone.
This randomized, controlled, parallel-group clinical trial will be conducted in the Department of Oral and Maxillofacial Surgery at Liaquat College of Medicine and Dentistry, Karachi, Pakistan. The planned study duration is six months. A total of 60 participants will be allocated in a 1:1 ratio to the two treatment groups using a sealed-envelope randomization method.
Participants assigned to the intervention group will receive oral curcumin 500 mg twice daily in combination with 0.1% triamcinolone acetonide ointment applied to the affected oral mucosa three times daily. Participants assigned to the control group will receive 0.1% triamcinolone acetonide ointment applied to the affected oral mucosa three times daily. Treatment and follow-up will be conducted according to the study protocol.
Clinical assessments will be performed at baseline and at 1, 3, and 6 months. Interincisal mouth opening will be measured in millimeters using a metallic ruler, and burning sensation will be assessed using a 10-point Visual Analog Scale (VAS). A blinded examiner will perform the clinical measurements to reduce observer-related measurement bias.
The primary outcome is the change in interincisal mouth opening from baseline to six months. The secondary outcome is the change in burning sensation VAS score from baseline to six months.
Data will be analyzed using IBM SPSS Statistics, Version 26. Quantitative variables will be summarized using means and standard deviations, where appropriate, and categorical variables using frequencies and percentages. Between-group comparisons will use the independent-samples t-test or Mann-Whitney U test, as appropriate to the distribution of the data. Repeated-measures analysis of variance will be used for within-group comparisons over time, where appropriate, and the chi-square test will be used for categorical variables. Statistical significance will be set at p ≤ 0.05.
The study will compare clinical changes between the two treatment groups to assess whether adjunctive oral curcumin provides additional benefit when combined with topical triamcinolone acetonide for the management of OSMF.
41 studies on the registry are indexed under Paresthesia; 10 are open to participants now.
This study's enrollment of 60 is above the median of 46 across 32 interventional studies indexed under Paresthesia.
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Age between 20-60 years
Exclusion Criteria:
Systemic illness (e.g., diabetes, immunocompromised status)
Participants receive oral curcumin 500 mg twice daily plus topical triamcinolone acetonide 0.1% three times daily for 6 months.
Other: Curcumin and and triamcinolone acetonide
Participants receive topical triamcinolone acetonide 0.1% three times daily for 6 months.
Other: Curcumin and and triamcinolone acetonide · Drug: Triamcinolone Acetonide
Oral curcumin 500 mg administered twice daily for 6 months and topical application of triamcinolone acetonide 3 times a day
Triamcinolone acetonide 0.1% ointment applied to the affected oral mucosa three times daily for 6 months.
interincisal mouth opening
The change in interincisal mouth opening from baseline to 6 months.
Time frame: 1,3, and 6 months
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Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Liaquat College of Medicine and Dentistry