NCT07891130

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 12, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 23, 2026

Completed
Last Updated

October 23, 2026

Status Verified

October 1, 2026

Enrollment Period

11 months

First QC Date

October 12, 2026

Last Update Submit

October 20, 2026

Conditions

Oral Submucous Fibrosis

Keywords

Oral Submucous FibrosisCurcuminTriamcinolone AcetonideTopical SteroidMouth OpeningBurning Sensation

Outcome Measures

Primary Outcomes (1)

  • interincisal mouth opening

    The change in interincisal mouth opening from baseline to 6 months.

    1,3, and 6 months

Study Arms (2)

Curcumin + Topical Steroid

EXPERIMENTAL

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

Triamcinolone Acetonide 0.1%

ACTIVE COMPARATOR

Participants receive topical triamcinolone acetonide 0.1% three times daily for 6 months.

Other: Curcumin and and triamcinolone acetonideDrug: Triamcinolone Acetonide

Interventions

Curcumin and and triamcinolone acetonideOTHER

Oral curcumin 500 mg administered twice daily for 6 months and topical application of triamcinolone acetonide 3 times a day

Curcumin + Topical SteroidTriamcinolone Acetonide 0.1%
Triamcinolone AcetonideDRUG

Triamcinolone acetonide 0.1% ointment applied to the affected oral mucosa three times daily for 6 months.

Triamcinolone Acetonide 0.1%

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 20-60 years
  • Clinical diagnosis of OSMF (Stages I or II based on Haider's classification)
  • Burning sensation score ≥ 4 on VAS
  • Interincisal mouth opening \<35 mm
  • Patients with no history of previous OSMF treatment

You may not qualify if:

  • Systemic illness (e.g., diabetes, immunocompromised status)
  • Pregnant or lactating women
  • Patients currently on any anti-inflammatory, antioxidant, or immunomodulatory drugs
  • Known allergy to curcumin or corticosteroids
  • TMJ disorders or any mechanical cause of trismus other than OSMF

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liaquat College of Medicine and Dentistry

Karachi, Sindh, 75400, Pakistan

Location

Related Publications (18)

  • 20. Khan AA, Akhter S. Trends of OSMF among adolescents in Lahore. J Coll Physicians Surg Pak. 2022;32(5):603-7.

    BACKGROUND

  • 19. More CB, Rao NR. Proposed clinical classification for OSMF. J Oral Maxillofac Pathol. 2019;23(1):101-6.

    BACKGROUND

  • 16. Ravindra SN, Kumar M, Baroi A. Use of curcumin with antioxidants in OSMF: a clinical study. J Neonatal Surg. 2023;14:2083.

    BACKGROUND

  • Adhikari S, Rimal J, Maharjan IK, Shrestha A. Efficacy of Curcumin in Combination with Intralesional Dexamethasone with Hyaluronidase in the Treatment of Oral Submucous Fibrosis: A Randomized Controlled Trial. Asian Pac J Cancer Prev. 2022 Sep 1;23(9):3125-3132. doi: 10.31557/APJCP.2022.23.9.3125.

    PMID: 36172675BACKGROUND

  • Deepak TA, Manjunath M, Thakur H. Efficacy of Curcumin and Topical Steroids in the Treatment for Oral Submucous Fibrosis: A Comparative study. J Pharm Bioallied Sci. 2021 Jun;13(Suppl 1):S542-S548. doi: 10.4103/jpbs.JPBS_687_20. Epub 2021 Jun 5.

    PMID: 34447150BACKGROUND

  • Guo JC, Xie H, Wu H, Tong TJ. [Efficacy of curcumin in the treatment of oral submucous fibrosis: a Meta-analysis]. Hua Xi Kou Qiang Yi Xue Za Zhi. 2021 Apr 1;39(2):195-202. doi: 10.7518/hxkq.2021.02.011. Chinese.

    PMID: 33834675BACKGROUND

  • 12. Wang Y, Chen X, Li Y. Curcumin suppresses myofibroblast differentiation in OSMF models. Int J Mol Sci. 2021;22(17):9334

    BACKGROUND

  • Zhang L, Tan J, Liu Y, Luo M. Curcumin relieves arecoline-induced oral submucous fibrosis via inhibiting the LTBP2/NF-kappaB axis. Oral Dis. 2024 May;30(4):2314-2324. doi: 10.1111/odi.14656. Epub 2023 Jun 29.

    PMID: 37382472BACKGROUND

  • Waghmare M, Pagare S, Bhor K, Srivastava R, Manoj R, Gavand K. Comparing efficacy of curcumin with other treatment modalities in oral submucous fibrosis management - A systematic review and meta-analysis. J Ayurveda Integr Med. 2024 Jul-Aug;15(4):100950. doi: 10.1016/j.jaim.2024.100950. Epub 2024 Jul 9.

    PMID: 38986267BACKGROUND

  • Chen X, Xie H, Guo J. Drug treatment for oral submucous fibrosis: an update. BMC Oral Health. 2023 Oct 12;23(1):748. doi: 10.1186/s12903-023-03488-9.

    PMID: 37828490BACKGROUND

  • 8. Patil S, Maheshwari S, Bagri-Manjrekar K. Curcumin: The Indian solid gold. Oral Oncol. 2017;68:110-8.

    BACKGROUND

  • She R, Xu P. Mechanism of curcumin in the prevention and treatment of oral submucosal fibrosis and progress in clinical application research. BDJ Open. 2024 Oct 25;10(1):82. doi: 10.1038/s41405-024-00268-7.

    PMID: 39455570BACKGROUND

  • 6. More CB, Rao NR, More M, Bhavsar K. Proposed clinical classification for OSMF. J Oral Maxillofac Pathol. 2019;23(1):101-6

    BACKGROUND

  • 5. Khan AA, Akhter S, Rehman S, Mirza T. Trends of OSMF among adolescents in Lahore. J Coll Physicians Surg Pak. 2022;32(5):603-7.

    BACKGROUND

  • 4. Ahmed S, Mehmood A, Iqbal T. Prevalence and risk factors of OSMF in Punjab, Pakistan. Pak Oral Dent J. 2020;40(2):72-6.

    BACKGROUND

  • 3. Mirza S, Alamgir W, Qazi S. Prevalence of oral submucous fibrosis among gutka users in Karachi. J Pak Dent Assoc. 2017;26(3):119-23.

    BACKGROUND

  • Borle RM, Borle SR. Management of oral submucous fibrosis: a conservative approach. J Oral Maxillofac Surg. 1991 Aug;49(8):788-91. doi: 10.1016/0278-2391(91)90002-4.

    PMID: 2072189BACKGROUND

  • Angadi PV, Rekha KP. Oral submucous fibrosis: a clinicopathologic review of 205 cases in Indians. Oral Maxillofac Surg. 2011 Mar;15(1):15-9. doi: 10.1007/s10006-010-0225-x.

    PMID: 20414694BACKGROUND

MeSH Terms

Conditions

Oral Submucous FibrosisParesthesia

Interventions

CurcuminTriamcinolone Acetonide

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesSomatosensory DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DiarylheptanoidsHeptanesAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicTriamcinolonePregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcome assessor will be blinded to treatment-group allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 12, 2026

First Posted

October 23, 2026

Study Start

October 10, 2025

Primary Completion

September 1, 2026

Study Completion

September 5, 2026

Last Updated

October 23, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)