NCT06758739

Brief Summary

The goal of this clinical trial is to learn if Curcumin is better than Intralesional Steroid Injection for the treatment of oral submucous fibrosis. The main question it aims to answers are:

  • Assessed for one month, two month and three month.
  • Burning Sensation will be assessed with visual analogue scale (VAS).
  • Mouth Opening will be measured in mm with ruler.
  • Tongue Protrusion will be assessed with the visual analogue scale (VAS).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2025

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

December 28, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 6, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

March 6, 2025

Status Verified

March 1, 2025

Enrollment Period

5 months

First QC Date

December 28, 2024

Last Update Submit

March 5, 2025

Conditions

Oral Submucous Fibrosis

Keywords

Potentially Malignant DisorderOral Submucous FibrosisIntralesional SteroidsCurcuminAnti-InflammatoryAnti-Fibrotic

Outcome Measures

Primary Outcomes (3)

  • Mean of Burning Sensation

    A burning sensation in oral submucous fibrosis is often due to tissue changes, dryness, nutritional deficiencies, or secondary infections affecting the oral mucosa. Patient will be asked for burning sensation \& based on severity numerical score given by VAS (Visual Analog Scale) 0-100.

    Monthl 1, Month 2, Month 3

  • Mean of Mouth Opening

    Mouth opening is progressively restricted due to fibroses and stiffness of oral tissue. It will be measured in mm. Patient will be asked to open mouth as wide as he/she can \& with the help of metal scale \& divider (Vernier caliper) between maxillary incisor \& mandibular incisor.

    Month 1, Month 2, Month 3

  • Mean of Tongue Protrusion

    Tongue Protrusion in oral submucous fibrosis refers to the difficulty or inability to fully move the tongue out of the mouth. It will be assessed from normal mesio-incisal angel of maxillary central incisor to the tip of tongue when maximally extended with wide mouth open by Visual Analogue Scale (VAS) 0-100.

    Month 1, Month 2, Month 3

Study Arms (2)

Group A

ACTIVE COMPARATOR

The Group A will undergo curcumin treatment for oral submucous Fibrosis. In Group A curcumin capsule (500 mg) will be given two per day. Patient will receive 1000 mg curcumin per day and will be assessed month on month basis for three months.

Drug: Curcumin (Turmeric)

Group B

EXPERIMENTAL

The Group B will undergo Intralesional Steroids treatment in oral submucous fibrosis. In Group B Intralesional Steroid Injection will be administered weekly and assessed on monthly basis for three months.

Drug: Intralesional Steroid Injection

Interventions

Curcumin (Turmeric)DRUG

Curcumin Capsule will be given two per day for three months. Patient Recovery progress will be monitored month on month basis for consecutive three month.

Group A
Intralesional Steroid InjectionDRUG

Intralesional Steroid Injection (1cc), one per week, will be administered in the fibrous bands wherever formed in the oral cavity. Patient recovery progress will be monitored on monthly basis for three months.

Group B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with Oral submucous fibrosis in accordance with operational definition.
  • Male \& Female

You may not qualify if:

  • Patient unable to quit the habit of gutkha, tobacco \& betel nut chewing
  • Patient With uncontrolled diabetes
  • Patient with chronic kidney disease
  • Pregnant female
  • Patient with untreated malignancy/taking immunosuppressant drugs
  • Patient with H/O ORAL SUBMUCOUS FIBROSIS in last months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Services Institute of Medical Sciences

Lahore, Punjab Province, 5400, Pakistan

Location

Related Publications (13)

  • Kerr AR, Warnakulasuriya S, Mighell AJ, Dietrich T, Nasser M, Rimal J, Jalil A, Bornstein MM, Nagao T, Fortune F, Hazarey VH, Reichart PA, Silverman S, Johnson NW. A systematic review of medical interventions for oral submucous fibrosis and future research opportunities. Oral Dis. 2011 Apr;17 Suppl 1:42-57. doi: 10.1111/j.1601-0825.2011.01791.x.

    PMID: 21382138BACKGROUND

  • Roques C, Teot L. The use of corticosteroids to treat keloids: a review. Int J Low Extrem Wounds. 2008 Sep;7(3):137-45. doi: 10.1177/1534734608320786. Epub 2008 Jul 8.

    PMID: 18611924BACKGROUND

  • Ramesh, D.N.S.V., Saba N. lycopene and combination of lycopene with multivitamins in the treatment of oral submucous fibrosis patients - A comparative study. Int. J Curr Res. 2017;9:53177-82.

    BACKGROUND

  • Piyush P, Mahajan A, Singh K, Ghosh S, Gupta S. Comparison of therapeutic response of lycopene and curcumin in oral submucous fibrosis: A randomized controlled trial. Oral Dis. 2019 Jan;25(1):73-79. doi: 10.1111/odi.12947. Epub 2018 Aug 22.

    PMID: 30059188BACKGROUND

  • Bohra A, Maheswari TNU, Harsh A, Garg A. Black Turmeric and Aloe Vera in the Management of Oral Submucous Fibrosis: A Prospective Clinical Study. Asian Pac J Cancer Prev. 2021 Dec 1;22(12):3941-3947. doi: 10.31557/APJCP.2021.22.12.3941.

    PMID: 34967575BACKGROUND

  • Yadav M, Aravinda K, Saxena VS, Srinivas K, Ratnakar P, Gupta J, Sachdev AS, Shivhare P. Comparison of curcumin with intralesional steroid injections in Oral Submucous Fibrosis - A randomized, open-label interventional study. J Oral Biol Craniofac Res. 2014 Sep-Dec;4(3):169-73. doi: 10.1016/j.jobcr.2014.11.003. Epub 2014 Nov 20.

    PMID: 25737939BACKGROUND

  • Nagpal M, Sood S. Role of curcumin in systemic and oral health: An overview. J Nat Sci Biol Med. 2013 Jan;4(1):3-7. doi: 10.4103/0976-9668.107253.

    PMID: 23633828BACKGROUND

  • Zhang SS, Gong ZJ, Li WH, Wang X, Ling TY. Antifibrotic effect of curcumin in TGF-beta 1-induced myofibroblasts from human oral mucosa. Asian Pac J Cancer Prev. 2012;13(1):289-94. doi: 10.7314/apjcp.2012.13.1.289.

    PMID: 22502687BACKGROUND

  • Aziz SR. Coming to America: betel nut and oral submucous fibrosis. J Am Dent Assoc. 2010 Apr;141(4):423-8. doi: 10.14219/jada.archive.2010.0194.

    PMID: 20354091BACKGROUND

  • Nigam NK, Aravinda K, Dhillon M, Gupta S, Reddy S, Srinivas Raju M. Prevalence of oral submucous fibrosis among habitual gutkha and areca nut chewers in Moradabad district. J Oral Biol Craniofac Res. 2014 Jan-Apr;4(1):8-13. doi: 10.1016/j.jobcr.2013.10.005. Epub 2013 Nov 20.

    PMID: 25737912BACKGROUND

  • Rajendran R, Deepthi K, Nooh N, Anil S. alpha4beta1 integrin-dependent cell sorting dictates T-cell recruitment in oral submucous fibrosis. J Oral Maxillofac Pathol. 2011 Sep;15(3):272-7. doi: 10.4103/0973-029X.86678.

    PMID: 22144828BACKGROUND

  • Pindborg JJ, Sirsat SM. Oral submucous fibrosis. Oral Surg Oral Med Oral Pathol. 1966 Dec;22(6):764-79. doi: 10.1016/0030-4220(66)90367-7. No abstract available.

    PMID: 5224185BACKGROUND

  • Hazarey VK, Erlewad DM, Mundhe KA, Ughade SN. Oral submucous fibrosis: study of 1000 cases from central India. J Oral Pathol Med. 2007 Jan;36(1):12-7. doi: 10.1111/j.1600-0714.2006.00485.x.

    PMID: 17181736BACKGROUND

MeSH Terms

Conditions

Oral Submucous Fibrosis

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

DiarylheptanoidsHeptanesAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Central Study Contacts

Hafiza Sara Adrees, BDS

CONTACT

+92 307 3002818saramidrees113@gmail.com

Hafiz Aamer Iqbal, BDS FCPS OMFS

CONTACT

+92 333 4955789haafiz.amer.iqbal@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post Graduate Resident OMFS

Study Record Dates

First Submitted

December 28, 2024

First Posted

January 6, 2025

Study Start

April 1, 2025

Primary Completion

September 1, 2025

Study Completion

October 1, 2025

Last Updated

March 6, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)