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Comparison of steroid releasing patch and steroid injections for oral submucous fibrosis

Comparison of the efficacy of topically applied mucosal patch with betamethasone and intralesional betamethasone in oral submucous fibrosis - A clinical study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/02/002437
Enrollment
24
Registered
2012-02-22
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: null- Patients with any stage of Oral submucous fibrosis and are willing to stop the habit of chewing betel quid/ Gutkha

Interventions

Intervention1: Betamethasone mucoadhesive buccal patch: A patch of Mucoadhesive buccal film with Betamethasone sodium phosphate, Hydroxy propyl methyl cellulose (HPMC) E5 LV and carbopol (CP) 940P as

Sponsors

DrUjjwal Joshi
Lead Sponsor
DrSumanth KN
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: a. Patient with any stage of oral submucous fibrosis b. Willing to stop the habit of chewing betel quid/ Gutkha c. No systemic disorders like diabetes mellitus, AIDS or Hypertension

Exclusion criteria

Exclusion criteria: a. Patients not stoping the chewing habit b. Patients not willing to get intralesional injections c. Patients who cannot come repeatedly for the treatment/ assessment

Design outcomes

Primary

MeasureTime frame
1. Mouth opening measured as inter incisal distance in millimeters 2. Burning sensation measured as 0 to 100 Visual analogue scaleTimepoint: Both outcomes are recorded after every week after treatment.

Secondary

MeasureTime frame
Discomfort level during the treatment procedure was recorded in patients own words as descriptive dataTimepoint: Once in a week after the treatment recieved

Countries

India

Contacts

Public ContactSumanth Kumbargere Nagraj

Manipal College of Dental Sciences,Mangalore

drujjwaljoshi@gmail.com08242428716

Outcome results

None listed

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