Steroid injections or Rebamipide tablets, which is better to treat painful and difficult mouth opening (OSMF)

A prospective analytical study on the efficacy of oral Rebamipide vs intralesional Triamcinolone + Hyaluronidase injection for the treatment of oral submucous fibrosis in a tertiary care hospital. - OSMF

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/12/048127

Enrollment

Registered

2022-12-14

Start date

Unknown

Completion date

Unknown

Last updated

2023-01-09

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: Rebamipide: oral, dose: 100mg TID x 28 days Control Intervention1: Triamcinolone: injection, intralesional, dose: 40mg once weekly, 4 doses Control Intervention2: Hyaluronidase: inject

Eligibility

Inclusion criteria

Inclusion criteria: Patients with OSMF with stomatopyrosis and/or grade 1 or 2 trismus Patients willing to take intralesional Triamcinolone + Hyaluronidase Patients willing to take oral Rebamipide tablets Patients willing to abstain from smoking/betel nut chewing (if addicted)

Exclusion criteria

Exclusion criteria: Patients not willing for follow up Patients with diagnosed oral malignancy Patients with grade 3 trismus or above

Design outcomes

Primary

Measure	Time frame
Reduction of trismus to grade 1 or 0 Resolution of stomatopyrosisTimepoint: 4 weeks after starting intervention	—

Secondary

Measure	Time frame
Increased patient compliance to treatmentTimepoint: 28 days	—

Countries

India

Contacts

Public ContactDr T Shankar

Osmania Medical College

drshankar_ms@yahoo.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026