A Clinical trial to study effectiveness of newly designed appliance for Oral submucous fibrosis.

Phase 2

Conditions: Health Condition 1: K135- Oral submucous fibrosis

Registration Number: CTRI/2021/06/034307

Lead Sponsor: DBT ATGC PROGRAM

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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

40 years.

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the impact of Novel physiotherapeutic appliance in the treatment of OSMF in terms of change in maximal mouth openingTimepoint: Each patients treatment will last 8 weeks, with patients being seen twice a week and followed up on twice a month for 3 months. Thus total duration for assessment is for 5 months. Each patient will be evaluated at the baseline, every 8-week care session, and every 15 days for the next three months. Thus a total of 22 progressive assessments at each visit.

Secondary Outcome Measures

Name	Time	Method
To assess change in Quality of life (QOL) by improvement in Inter-Incisal Distance (IID) by physiotherapyTimepoint: For qualitative assessment, regarding Quality of Life, a standardized questionnaire will be evaluated between the comparative A and B group by the Research associate at pretreatment, after 8 weeks of treatment and at the end of the treatment for the individual patients. <br/ ><br>Five points â??Likert rating scaleâ?? has been added in the questionnaire to get the quantitative assessment. The patient will give a score of his/ her condition at initial and subsequent follow up, which will be noted.