Role of ultrasound therapy with steroids (4mg/ml) as intervention in participants having oral submucous fibrosis

A Comparative Assessment Of the Efficacy of Therapeutic Ultrasound with Intralesional Dexamethasone (4mg/ml) Versus Jaw Stretcher with Intralesional Dexamethasone (4mg/ml) in treatment of Oral Submucous Fibrosis- A Double Blind RANDOMISED CONTROL STUDY - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2026/02/102799

Enrollment

Registered

2026-02-02

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K135- Oral submucous fibrosis

Interventions

Intervention1: Intralesional injection of 2 ml dexamethasone (4 mg/ ml) with therapeutic ultrasound will be delivered using a frequency of 3 MHz at a continuous mode with an intensity of 2.5 W/cm .: I

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients clinically diagnosed with stage 2 or 3 of OSMF based on Khanna and Andrade (1995) classification. 2.Patients with no contraindications or documented allergies to the medication which are being used for the study. 3.Patients willing to give consent for the study.

Exclusion criteria

Exclusion criteria: 1.Previously treated patients of OSMF in the last 3 months or those who have left treatment in between or undergoing any other treatment modality. 2.Pregnant and lactating mother 3.Physically challenged and syndromic patients. 4.Patients having malignancy or infection in the vicinity of the treatment site. 5.Posterior Edentulous patients and patients with very poor periodontal health.

Design outcomes

Primary

Measure	Time frame
1.To ascertain the improvement in the mouth opening, if any, measured with the Vernier caliper in both the groups. 2.To ascertain the improvement in the burning sensation felt by the patient using VAS scale in both the groups. 3.To ascertain the mucosal changes in both the treatment modalities. Timepoint: Each primary outcome will be assessed at baseline ,then twice weekly for four weeks with intervention and once weekly for two weeks without intervention.	—

Measure

Time frame

1.To ascertain the improvement in the mouth opening, if any, measured with the Vernier caliper in both the groups. 2.To ascertain the improvement in the burning sensation felt by the patient using VAS scale in both the groups. 3.To ascertain the mucosal changes in both the treatment modalities. Timepoint: Each primary outcome will be assessed at baseline ,then twice weekly for four weeks with intervention and once weekly for two weeks without intervention.

—

Secondary

Measure	Time frame
1.To compare the burning sensation, mouth opening & mucosal changes between the two groups. 2. To evaluate any side effects with both the treatment modalities. Timepoint: Each secondary outcome will be assessed at baseline ,then twice weekly for four weeks with intervention & once weekly for two weeks without intervention.	—

Countries

India

Contacts

Public ContactDr Poulomi Pal

Government Dental College and Hospital

drvijayaomr@gmail.com9676557606

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026