CTRI/2021/06/034307Not yet recruitingPhase 2
Comparative efficacy a newly designed physio-therapeuticappliance for the treatment of Oral Sub-Mucous Fibrosis
DBT ATGC PROGRAM0 sites0 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •1. Adverse history of chronic chewing habits of areca nut, tobacco, or both for more than 2 years.
- •2. The patients with reduced mouth opening having a maximal mouth opening range of 20-34mm.
- •3. Patients of age group between 18-40 years will be enrolled. Both adult males and females will be recruited. In the adults above the age of 40 years pathological periodontal diseases are observed, hence age will be limited up to
- •4. Teeth present central incisor to the second molar in all quadrants with good periodontal health.
Exclusion Criteria
- •1.Trismus owing to diseases other than OSMF such as
- •a. Systemic diseases like sclerosis, tetany,
- •b. Odontogenic causes like pericoronitis, third molar removal,
- •c. TMJ disorder or masticatory apparatus dysfunction,
- •d. Non-odontogenic infection- Meningitis, Tetanus, Peritonsillar / Parotid abscess
- •2. Presence of other mucosal diseases (oral cancer, lichen planus, and leukoplakia),
- •3. Any active odontogenic infection causing swelling/pain or trismus.
- •4. Subjects having periodontal diseases like pyorrhea will not be included.
- •5. Patients should not have taken any prior treatment for the OSMF.
- •6. Presence of any deleterious habit (e.g., bruxism),
- •7. Patient with partial edentulism.
- •8. Patients with psychotic behavior or not willing to comply with the treatment
- •protocol & follow-up will be excluded.
Investigators
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