se of ultrasound technique to increase reduced mouth opening due to habits like tobacco and gutka consumptio

Phase 3

Completed

• Conditions: Health Condition 1: K135- Oral submucous fibrosis

• Registration Number: CTRI/2023/08/056053
• Lead Sponsor: Dr Vijayalakshmi K R

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2024-03-31
• Last Update Posted: 1 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

1. Subjects between 18 to 60 years of age without gender bias.

2. Subjects with clinical stage 1, 2 or 3 and functional stage 2, 3, or 4 according to More et al (2012) classification

Exclusion Criteria

1. Pregnant and lactating subjects.

2. Subjects presenting open or infected wound, eczema in the region of masseter muscle where ultrasound has to be administered.

3. Subjects with dental implants or abscess in the area of ultrasound application.

•Subjects having vascular diseases, cardiac diseases, or cardiac pacemakers.

•Subjects undergoing treatment for OSMF or any other oral potentially malignant disorder (OPMD) or other systemic pre-cancerous or cancerous conditions.

•Subjects with decreased mouth opening for reasons other than OSMF like pericoronitis, post-extraction trismus.

•Subjects with missing maxillary and/ or mandibular incisors.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Increase in mouth openingTimepoint: 0, 4 weeks

Secondary Outcome Measures

Name	Time	Method
Tongue protrusion <br/ ><br>Cheek flexibility <br/ ><br>VAS scoreTimepoint: 0, 4 weeks