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Clinical Trials/CTRI/2021/06/034307
CTRI/2021/06/034307
Not Yet Recruiting
Phase 2

Comparative efficacy a newly designed physio-therapeuticappliance for the treatment of Oral Sub-Mucous Fibrosis

DBT ATGC PROGRAM0 sites0 target enrollmentTBD
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ConditionsHealth Condition 1: K135- Oral submucous fibrosis

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Health Condition 1: K135- Oral submucous fibrosis
Sponsor
DBT ATGC PROGRAM
Status
Not Yet Recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
DBT ATGC PROGRAM

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),

Outcomes

Primary Outcomes

Not specified

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