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To determine the benefits of rebamipide in combination with intralesional injection of hyaluronidase and dexamethasone in reducing the burning sensation in patients with oral submucous fibrosis

Compare the efficacy of rebamipide as an adjuvant versus intralesional injection of hyaluronidase and dexamethasone alone in improving mouth opening and burning sensation in grade IIand grade III oral submucous fibrosis.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/03/024382
Enrollment
40
Registered
2020-03-31
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: D103- Benign neoplasm of other and unspecified parts of mouth Health Condition 2: K135- Oral submucous fibrosis

Interventions

Intervention1: Intralesional injection of hyaluronidase and dexamethasone and oral rebamipide: Biweekly intralesional injection of hyaluronidase 1500IU and dexamethasone 4mg and oral rebamipide 100mg

Sponsors

NGMOGESHVAAR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with vertical fibrous bands in the oral cavity and histopathologically proven oral submucous fibrosis. Grade 2 and grade 3 oral submucous fibrosis

Exclusion criteria

Exclusion criteria: Grade 1 and grade 4 oral submucous fibrosis Patients who refuse to quit the tobacco chewing habit Uncooperative patients

Design outcomes

Primary

MeasureTime frame
Reduction in burning sensation assessed using VAS Scale (0 to 10)Timepoint: At baseline and at end of 4th week.—

Secondary

MeasureTime frame
Improvement in mouth opening assessed by measuring the interincisal distance.Timepoint: At baseline and at end of 4th week—

Countries

India

Contacts

Public ContactNGMOGESHVAAR

Rajah muthiah dental college and hospital

vgnsrs71@gmail.com09443124179

Outcome results

None listed

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