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Effectiveness of a mouth opening device in improving mouth opening in Oral Submucous Fibrosis Patients A Randomized Clinical Trial

Effectiveness of Mouth Opening Device (MOD) as an adjunct to intralesional corticosteroid injection in the management of Oral Submucous Fibrosis A Single-Blinded Randomized Clinical Trial - Nil

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/095192
Enrollment
28
Registered
2025-09-22
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

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 Dexamethasone 4 mg with Hyaluronidase 1500 with Mouth opening device: Administer intralesional injection of Dexamethasone 4mg with Hyaluronidase 1500 IU weekl

Sponsors

Dr Pavithra G
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Clinical diagnosis of OSMF 2. Mouth opening between 20 30 mm (according to Lydner s classification group C) 3. No prior treatment for OSMF in the last 6 months

Exclusion criteria

Exclusion criteria: 1. Patients not willing to participate in study 2. OSMF patients with acute dental infection or associated with other lesions like leukoplakia, stomatitis nicotina, carcinoma, etc 3. Patients with reduced mouth opening due to trauma, radiation, surgery, developmental disorders, TMDs or any other disease that mimics OSMF such as systemic sclerosis, tetany (screened by medical history/ questionnaire), etc 4. Patients with early stage of OSMF 5. Patients previously treated with intralesional injection and/or ultrasound therapy for OSMF 6. Patients with any systemic disease such as uncontrolled diabetes, hepatic, respiratory, renal, cardiac, hematological disease, tuberculosis, or immunocompromised states where steroid administration is contraindicated

Design outcomes

Primary

MeasureTime frame
Increase in interincisal mouth opening (mm).Timepoint: 3rd week, 6th week

Secondary

MeasureTime frame
1. Reduction in burning sensation (VAS score) 2. Improvement in oral health-related quality of life (OHIP-14 score)Timepoint: 3rd week, 6th week

Countries

India

Contacts

Public ContactDr Zameera Naik

KLE Vishwanath Katti Institute of Dental Sciences

paviviji75@gmail.com9677533351

Outcome results

None listed

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