Comparison of Curcumin and Intralesional Steroids in Oral Submucous Fibrosis

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorServices Institute of Medical Sciences, Pakistan

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Male & Female

Disqualifiers

Patient unable to quit the habit of gutkha, tobacco & betel nut chewing

Patient With uncontrolled diabetes

Patient with chronic kidney disease

Pregnant female

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Intralesional Steroid Injection

    Drug

    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.

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Group AActive comparator 1 intervention
Group B: Group BExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Monthl 1, Month 2, Month 3
2

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.

Time frame
Month 1, Month 2, Month 3
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.

Time frame
Month 1, Month 2, Month 3

Secondary outcomes

Other outcomes

Sponsors and contacts

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