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A study to test the Effectiveness of Chewy Tubes R alongwith intralesional steroids in improving the Mouth Opening in Patients Suffering from Oral Submucous Fibrosis

Effectiveness of Chewy Tubes R in enhancing Mouth Opening in Patients Suffering from Oral Submucous Fibrosis; A Randomized Controlled Trial - Nil

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/03/081918
Enrollment
38
Registered
2025-03-07
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Health Condition 1: L00-L99- Diseases of the skin and subcutaneous tissue

Interventions

Intervention1: CHEWY TUBES R: Chewy Tubes ® have been invented as an aid for managing speech pathologies in children. These “Silicon devices ? are easy to handle and motivates the user to chew on it.

Sponsors

Speech Pathology Associates LLC
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients suffering from stages II and III OSMF will be included (as per Khanna and Andrade Classification).

Exclusion criteria

Exclusion criteria: Patients suffering from Stage I and Stage IV OSMF with mouth opening of less than 18 mm will not be included. 2) Patients who are not willing to participate in the study. 3) Patients allergic to Chewy Tubes®.

Design outcomes

Primary

MeasureTime frame
1.To evaluate the interincisal distance in patients undergoing intralesional steroid injections versus those undergoing a combination of intralesional steroid injections and chewy tubes at the end of one month of treatment.Timepoint: once a week for four weeks

Secondary

MeasureTime frame
2. To evaluate burning sensation in both the groupsTimepoint: once a week for four weeks

Countries

India

Contacts

Public ContactDr. Jasmine Jophy

Manipal College of Dental Sciences,Mangalore.

ravikiran.ongole@manipal.edu8921873248

Outcome results

None listed

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