| CTRI Number |
CTRI/2024/06/068782 [Registered on: 12/06/2024] Trial Registered Prospectively |
| Last Modified On: |
26/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
New physiotherapy device for mounth opening in patients with Oral Submucous fibrosis |
|
Scientific Title of Study
|
Development of new physiotherapy device and assessment of its effectiveness compared to traditionally used method in treatment of Oral Submucous Fibrosis: A Randomized Controlled Experimental Study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashish S Bodhade |
| Designation |
Asso Prof |
| Affiliation |
VSPM DCRC, nagpur |
| Address |
Dept of Oral Pathology VSPM DCRC, Nagpur 440019
Digdoh Hills, Hingana Road, Nagpur.
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9422475735 |
| Fax |
|
| Email |
ashishbodhade@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Alka M Dive |
| Designation |
PhD Guide |
| Affiliation |
Ranjeet Deshmukh Dental College & Research Centre (RDDC & RC) |
| Address |
Dept of Oral Pathology, Ranjeet Deshmukh Dental College & Research Centre (RDDC & RC) , Nagpur 440019
Digdoh Hills, Hingana Road, Nagpur.
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9822992622 |
| Fax |
|
| Email |
dive_alka@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ashish S Bodhade |
| Designation |
Asso Prof |
| Affiliation |
VSPM DCRC, nagpur |
| Address |
Dept of Oral Pathology VSPM DCRC, Nagpur 440019
Digdoh Hills, Hingana Road, Nagpur.
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9422475735 |
| Fax |
|
| Email |
ashishbodhade@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ranjeet Deshmukh Dental College & Research Centre (RDDC & RC) Nagpur, MS, 440019, India |
|
|
Primary Sponsor
|
| Name |
Dr Ashish Bodhade |
| Address |
Ranjeet Deshmukh Dental College & Research Centre (RDDC & RC) Nagpur MS 440019 India |
| Type of Sponsor |
Other [Self ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ashish Bodhade |
Ranjeet Deshmukh Dental College & Research Centre (RDDC & RC) |
Department of Oral Pathology & Microbiology, Annex Building, Digdoh Hill Hingana Road Nagpur
Nagpur
MAHARASHTRA |
9422475735
ashishbodhade@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC RDDC & RC, Nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R688||Other general symptoms and signs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ice cream stick method used for physiotherapy exercises. |
Routinely used method of Ice cream stick method used for physiotherapy exercises. In this stack of ice cream stick were used for stretching mouth placed interincisally in upper and lower jaws. Duration will be twice daily follow up after one & Three months. Total Three months |
| Intervention |
Mouth opening device for physiotherapy along with combination medicine |
Mouth opening device for physiotherapy designed for OSMF patients which gives opening and stretching exercises. Duration will be twice daily follow up after one & Three months. Total Three months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Kharra chewing with restricted mouth opening.
2. Clinically diagnosed cases of OSMF stage I, II, & III.
3. Patients willing to participate
|
|
| ExclusionCriteria |
| Details |
Patients less than 18 years and more than 75 years.
Any malignancy or any debilitating conditions |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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
|
| Outcome |
TimePoints |
| 3. Improvement in burning sensation an ulceration. |
1. First at base line 2. After 1month 3. After 3 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/06/2024 |
| Date of Study Completion (India) |
27/09/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [ashishbodhade@gmail.com].
- For how long will this data be available start date provided 28-05-2024 and end date provided 18-01-2025?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
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. |