COMPARING TWO DEVICES FOR PROVIDING JAW STRETCHING EXERCISES IN PEOPLE HAVING REDUCED MOUTH OPENING.

Phase 4

• Conditions: Health Condition 1: R252- Cramp and spasm

• Registration Number: CTRI/2021/05/033383
• Lead Sponsor: Dr Shambhavi Nadkarni

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.All patients above 21 years of age reporting with Trismus

2.Patients with Group 1 or Group 2 or Group 3 Oral Submucous Fibrosis(Khanna & Andrade clinical classification,1995)

3.Patients having trismus post normal or complicated tooth extraction or post traumatic needle injury

4. Patients with fascial space infections.

5.Patients who give consent to participate in the study.

Exclusion Criteria

1.Patients not giving consent for participation in the study

2.Patients having trismus post radiation therapy for cancer or TMJ ankylosis

3. Mentally challenged patients, pregnant (except 2nd trimester), those with severe systemic conditions (ASA IV), bone infections, osteomyelitis or osteoradionecrosis of jaw

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
a.Increase or decrease in pain during physiotherapy measured on a Visual Analogue Scale <br/ ><br>b.Amount of increase in Maximal Interincisal Opening (MIO) measured by Vernier caliper <br/ ><br>c.High or low level of Quality of life in patients based on Gothenburg Trismus Questionnaire (GTQ) scores <br/ ><br>Timepoint: All variables will be recorded on <br/ ><br>For Group A on 1st day. 3rd day. 5th day. 7th day. 15th day. 1st month. 2nd month. thereafter at the end of each month upto 6 months <br/ ><br>For Group B on 1st day. 3rd day. 5th day. 7th day and 15th day. <br/ ><br>For Group C on 1st day. 3rd day. 5th day. 7th day. 15th day and end of 1st month. <br/ ><br> <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
Pressure exerted by device on the jaws during physiotherapy recorded by Novel Jaw Stretching Device at <br/ ><br>0.5 cm stretch <br/ ><br>1cm stretch and at <br/ ><br>maximum tolerable stretch <br/ ><br>Timepoint: All variables will be recorded on <br/ ><br>For Group A on 1st day. 3rd day. 5th day. 7th day. 15th day. 1st month. 2nd month. thereafter at the end of each month upto 6 months <br/ ><br>For Group B on 1st day. 3rd day. 5th day. 7th day and 15th day. <br/ ><br>For Group C on 1st day. 3rd day. 5th day. 7th day. 15th day and end of 1st month.