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

COMPARISON OF A NOVEL JAW STRETCHING DEVICE WITH HEISTER JAW OPENER FOR PROVIDING PHYSIOTHERAPY IN PATIENTS WITH TRISMUS- A RANDOMIZED CONTROLLED TRIAL.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/05/033383

Enrollment

Registered

2021-05-05

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: R252- Cramp and spasm

Interventions

Intervention1: Novel Jaw Stretching Device: The Novel Jaw stretching Device is a original invention designed to provide physiotherapy in patients with trismus for rehabilitation of jaw function. Maxim

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
a.Increase or decrease in pain during physiotherapy measured on a Visual Analogue Scale b.Amount of increase in Maximal Interincisal Opening (MIO) measured by Vernier caliper c.High or low level of Quality of life in patients based on Gothenburg Trismus Questionnaire (GTQ) scores Timepoint: All variables will be recorded on 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 For Group B on 1st day. 3rd day. 5th day. 7th day and 15th day. For Group C on 1st day. 3rd day. 5th day. 7th day. 15th day and end of 1st month.	—

Measure

Time frame

a.Increase or decrease in pain during physiotherapy measured on a Visual Analogue Scale b.Amount of increase in Maximal Interincisal Opening (MIO) measured by Vernier caliper c.High or low level of Quality of life in patients based on Gothenburg Trismus Questionnaire (GTQ) scores Timepoint: All variables will be recorded on 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 For Group B on 1st day. 3rd day. 5th day. 7th day and 15th day. For Group C on 1st day. 3rd day. 5th day. 7th day. 15th day and end of 1st month.

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Secondary

Measure	Time frame
Pressure exerted by device on the jaws during physiotherapy recorded by Novel Jaw Stretching Device at 0.5 cm stretch 1cm stretch and at maximum tolerable stretch Timepoint: All variables will be recorded on 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 For Group B on 1st day. 3rd day. 5th day. 7th day and 15th day. For Group C on 1st day. 3rd day. 5th day. 7th day. 15th day and end of 1st month.	—

Measure

Time frame

Pressure exerted by device on the jaws during physiotherapy recorded by Novel Jaw Stretching Device at 0.5 cm stretch 1cm stretch and at maximum tolerable stretch Timepoint: All variables will be recorded on 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 For Group B on 1st day. 3rd day. 5th day. 7th day and 15th day. For Group C on 1st day. 3rd day. 5th day. 7th day. 15th day and end of 1st month.

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Countries

India

Contacts

Public ContactDr Shambhavi Nadkarni

Government Dental College and Hospital, Mumbai

prajwalitkende1979@gmail.com9324715824

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026