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Exercise device to increase mouth opening in reduced mouth opening conditions

Evaluation of clinical efficacy of a new mouth-exercising device in association with local ointment application, intra-lesional drug administration and surgical treatment for oral submucous fibrosis - MEDCT

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/05/003609
Enrollment
225
Registered
2013-05-03
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- Oral submucous fibrosis

Interventions

Intervention1: Mouth Exercising Device (MED) group: Duration of therapy: 6 months 1. Oral antioxidant: once in a day + local steroid ointments twice a day and ice-cream-stick regime for mouth exercise

Sponsors

Government Dental College and Hospital Nagpur
Lead Sponsor
Lady Tata Memorial Trust Mumbai
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Oral submucous fibrosis patients who agrees to participate in the clinical trial and assures to cooperate to undergo the intervention and ready to come for the follow up visits.

Exclusion criteria

Exclusion criteria: 1. Patients with istory of systemic disease with hepatic, respiratory, renal, cardiac or haematological disease. 2. Patients with presence of any malignancy associated. 3. Patient with persistent infection or severe infection in the last 3 months. 4. Patient who cannot be relied upon to comply or who are unwilling to sign informed consent. 5. Patients requiring treatment during the study period with drugs not permitted by the study protocol.

Design outcomes

Primary

MeasureTime frame
1. Interincisal distance on maximum mouth opening in mm 2. Visual Analogue Scale in percentage for burning sensationTimepoint: 1. 6 months 2. 6 months

Secondary

MeasureTime frame
Difficulty in eating and swallowingTimepoint: 6 months

Countries

India

Contacts

Public ContactDr Pravinkumar G Patil

Government Dental College and Hospital, Nagpur

pravinandsmita@yahoo.co.in09923294699

Outcome results

None listed

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