New physiotherapy device for mounth opening in patients with Oral Submucous fibrosis

Completed

Conditions: Other general symptoms and signs,

Registration Number: CTRI/2024/06/068782

Lead Sponsor: Dr Ashish Bodhade

Brief Summary: Several studies have underlined the importance of physiotherapy in the management of Oral Submucous Fibrosis (OSMF). Traditionally used methods of physiotherapy such as using ice cream sticks, tapered screw, and the blowing of conch shells or balloons have been widely recommended due to their simplicity, accessibility, and cost-effectiveness.

Among these traditional techniques, the use of ice cream sticks has been a common endorsement. Patients were advised to stack and insert the sticks between their teeth to gradually increase mouth opening. Despite its widespread use, there is a notable lack of rigorous studies evaluating the effectiveness and patient compliance associated with the ice cream stick method.

The primary advantage of using ice cream sticks lies in their low cost and ease of access. However, the absence of systematic research leaves questions regarding their efficacy and patient adherence unanswered. As a result, there is a pressing need for the development of customized devices tailored specifically for OSMF patients. These new devices should aim to provide controlled and gradual stretching of the oral tissues, potentially incorporating advanced technology to enhance effectiveness and patient comfort.

Current literature lacks robust evaluations of both traditional methods and newer devices designed for mouth opening in OSMF patients. Some existing devices are not popular being either costly or for exerting excessive forces, highlighting the need for a balanced approach in device design.

Therefore, developing new, technologically advanced devices that meet the specific therapeutic needs of OSMF patients and conducting clinical studies to assess their effectiveness compared to traditional methods like the ice cream stick technique is essential. Such advancements could significantly improve treatment outcomes and patient quality of life, addressing a critical gap in the current management of OSMF.

This is a experimental study on OSMF patients. with restricted mouth opening. In this experimental study we are comparing new device which is affordable and handy than old method of using ice cream sticks for moth opening in these patients. Rest of the treatment is same in both groups which routinely prescribed in these patients for mouth opening and controlling burning and ulceration..

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 100

Inclusion Criteria

Kharra chewing with restricted mouth opening.
Clinically diagnosed cases of OSMF stage I, II, & III.
Patients willing to participate.

Exclusion Criteria

Patients less than 18 years and more than 75 years.
Any malignancy or any debilitating conditions.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Difference in Interincisal mouth opening (Distance between upper and lower incisors) in millimeter taken by vernier calipper at 3 visits will be compared difference will compared. 1. Base line Interincisal mouth opening 2. After 1month visit 3. After 3 months visit.	1. Base line Interincisal mouth opening 2. After 1month visit 3. After 3 months visit at three point time.

Secondary Outcome Measures

Name	Time	Method
3. Improvement in burning sensation an ulceration.	1. First at base line 2. After 1month 3. After 3 months

Trial Locations

Locations (1): Ranjeet Deshmukh Dental College & Research Centre (RDDC & RC)
🇮🇳
Nagpur, MAHARASHTRA, India
Ranjeet Deshmukh Dental College & Research Centre (RDDC & RC)
🇮🇳Nagpur, MAHARASHTRA, India
Dr Ashish Bodhade
Principal investigator
9422475735
ashishbodhade@gmail.com