Clinical trial NCT06758739: Comparison of Curcumin and Intralesional Steroids in Oral Submucous Fibrosis
Official title: Comparison of Curcumin and Intralesional Steroids in Oral Submucous Fibrosis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Oral Submucous Fibrosis
Keywords: Potentially Malignant Disorder
Oral Submucous Fibrosis
Intralesional Steroids
Curcumin
Anti-Inflammatory
Anti-Fibrotic
Lead sponsor: Services Institute of Medical Sciences, Pakistan
Sponsor class: OTHER_GOV
First posted: 2025-01-06
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

1. If Curcumin is more effective to improve burning sensation as compared to Intralesional steroid.
2. Does Curcumin treatment results in better mouth opening versus Intralesional steroid.
3. Can Curcumin helps to improve tongue protrusion as compared to Intralesional steroids.

Participants will be:

* 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).

Detailed description: Objective:

To compare the efficacy of Curcumin versus Intralesional steroids in term of burning sensation, mouth opening and tongue Protrusion

Hypothesis:

Curcumin is more effective in terms of burning sensation, mouth opening (interincisal distance) and tongue Protrusion as compared to intralesional steroids.

Operational Definitions:

Oral submucous fibrosis is chronic, slowly progressive precancerous condition caused by areca nut characterized by restricted mouth opening, burning sensation, stiffness and blanching of mucosa and limitation of tongue Protrusion9. It will be clinically assessed as difficulty in mouth opening, burning sensation, fibrous bands \& blanching of mucosa along with limited tongue movement.

Efficacy:

Efficacy of Curcumin \& intralesional steroids will be assessed in terms of burning sensation VAS score, mouth opening \& Tongue Protrusion

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 feels pain or discomfort in mouth especially when eating hot or spicy food Patient will be asked for burning sensation \& based on severity numerical score given by VAS (Visual Analog Scale) (Bohra et al.)9

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 mental scale \& divider (Vernier caliper) between maxillary incisor \& mandibular incisor9.

Tongue Protrusion:

Tongue Protrusion in oral submucous fibrosis refers to the difficulty or inability to fully move the tongue out of the mouth due to stiffness and restricted mobility caused by fibrotic changes in the oral tissues. 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 (Ramesh et al.)11

Material and Methods:

Study Design:

Randomized Central trial (RCT)

Study Setting:

Department of Oral \& Maxillofacial surgery, Services Institute of Medical Sciences Lahore

Duration of Study:

Six months

Sample Size: A sample size will be of 70 patients (35 in each group). Calculated using the expected mean difference of burning sensation VAS score between curcumin group and intralesional steroids inj.

Sampling Technique:

Non-probability purposive sampling technique.

Sample Selection:

Inclusion Criteria:

Patients diagnosed with Oral submucous fibrosis in accordance with operational definition.

Male \& Female

Exclusion Criteria:

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

Data Collection Procedure:

All eligible patients undergoing oral submucous fibrosis treatment will be invited to participate in the study and informed consent will be obtained from all the volunteer participants. Total 70 (35 in each group) will be randomized into two equal size groups i.e. Group A and B by using online computer-generated program which concealed randomization and treatment allocation. A structured Proforma will be used to call demographic and clinical data. Before treatment, baseline burning sensation, mouth opening (interincisal distance) and tongue Protrusion will be noted. In group A, Patient will receive Curcumin Capsule (nutrifactor) 2 per day for 3 months. In group B, Patient will receive intralesional steroid injection 4mg/1cc weekly for 3 months. Participants health care provider, data collector and outcome assessors will be blinded to the treatment allocation. Patient will be assessed for burning sensation, INTERINCISAL DISTANCE \& tongue protrusion monthly. As per operational definitions, efficacy in terms of burning sensation VAS score, greater inter Incisal distance \& tongue Protrusion will be compared between Curcumin and Intralesional steroid groups.

Data Collection Tools:

All Study variables will be assessed by single person at Month 1, Month 2 and Month 3 post clinical trial. Clinical parameters will be assessed through proforma designed in English as well as in Local language.

Data Analysis Procedure:

Statistical Package for Social Sciences (SPSS) version 27 will be used for data entry \& analysis. The quantitative variables such as age, burning sensation VAS score, mouth opening \& tongue Protrusion, will reported using mean ± standard deviation. The quantitative variable such as gender will be reported using percent. The baseline profile between groups will be compared using student t-test. The improvement within the group by the end of 1st, 2nd \& 3rd month will be tabulated \& analyzed. The clinical improvement of a particular regimen (within the same group) before \& after treatment will be analyzed using paired t-test. The improvement observed serially within the same group will be evaluated using repeated measures ANOVA. Comparisons between the two groups will be done using unpaired t-test.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Mean of Burning Sensation
timeFrame: Monthl 1, Month 2, Month 3
measure: Mean of Mouth Opening
timeFrame: Month 1, Month 2, Month 3
measure: Mean of Tongue Protrusion
timeFrame: Month 1, Month 2, Month 3
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Services Institute of Medical Sciences
state: Punjab
Study officials:
References:
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