| CTRI Number |
CTRI/2025/05/086826 [Registered on: 13/05/2025] Trial Registered Prospectively |
| Last Modified On: |
12/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Different Modes of mouth exercise in OSMF |
|
Scientific Title of Study
|
Comparing Different Modes of Mouth Exercise in OSMF Grade II Patients– A Randomised Control Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Achom Uma Devi |
| Designation |
PG Student |
| Affiliation |
ITS Dental College, Muradnagar |
| Address |
Department of Oral Medicine and Radiology,
Room No.1
ITS Dental College, Muradnagar
ITS Dental College, Muradnagar, Uttar Pradesh
Ghaziabad
UTTAR PRADESH
201206
India |
| Phone |
9315480087 |
| Fax |
|
| Email |
umaachom80@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Akshay Rathore |
| Designation |
Professor |
| Affiliation |
ITS Dental College, Muradnagar |
| Address |
Department of Oral Medicine and Radiology,
Room No.1
ITS Dental College, Muradnagar
ITS Dental College, Muradnagar
Ghaziabad
UTTAR PRADESH
201206
India |
| Phone |
9999674543 |
| Fax |
|
| Email |
drrathoreakshay@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Achom Uma Devi |
| Designation |
Post Graduate fellow |
| Affiliation |
ITS Dental College, Muradnagar |
| Address |
Department of Oral Medicine and Radiology,
Room No.1
ITS Dental College, Muradnagar
Department of Oral Medicine and Radiology,
Room No.1
ITS Dental College,Muradnagar
Ghaziabad
UTTAR PRADESH
201206
India |
| Phone |
9315480087 |
| Fax |
|
| Email |
umaachom80@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Achom Uma Devi |
| Address |
ITS Dental College, Muradnagar, Uttar Pradesh,
District- Ghaziabad
Pin code- 201206
|
| 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 |
| Achom Uma Devi |
ITS Dental College, Muradnagar |
Department of Oral Medicine and Radiology,
Room no.1,
Muradnagar,
Uttar Pradesh, Pin code- 201206
Ghaziabad
UTTAR PRADESH |
09315480087
umaachom80@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ITS INSTITUITIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K135||Oral submucous fibrosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
balloon exercise EXERCISE FOR 8 WEEKS (2MONTHS) |
Ballooning exercises were taught to the patient. Instructions were given to blow the balloon 4-5 times a day for 8 weeks (2 MONTHS) |
| Comparator Agent |
ice cream stick- EXERCISE FOR 8 WEEKS (2MONTHS) |
Ice-cream-stick exercise were taught to the patient. Instructions were given and asked to undertake jaw exercise five times a day for 8 weeks, in which ice cream stick were positioned passively between anterior teeth, number determined by comfortable maximal oral opening. The jaws were opened five times in each session, and held in position with the teeth resting on the stick for 1 minute on each occasion- FOR 2 MONTHS |
| Intervention |
mouth opener device EXERCISE FOR 8 WEEKS (2MONTHS) |
Mouth opener device exercise were taught to the patient. Patient were instructed to place the mouth opener device between the incisor teeth and rotate in clockwise direction manually ten times twice a day for 8 weeks(2 MONTHS) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
clinical signs and symptoms of OSMF grade II with an inter-incisal distance 26-35mm |
|
| ExclusionCriteria |
| Details |
malignant lesions, patients with smoking history, presence of any oral or systemic inflammatory conditions |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The management of OSMF patients should primarily be focused towards improving the MO and increasing flexibility of the oral mucosa to halt the possibility of malignant changes and thus mouth exercise physical therapy independently or in combination with other modalities may be useful to improve mouth opening (MO) in OSMF. |
2 MONTHS |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/05/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
For this clinical study, detailed case history will be taken for all the patients reporting to the OPD of Oral medicine and radiology with complaint of reduced mouth opening with history of tobacco chewing habits. All the clinical signs and symptoms of Oral submucous fibrosis were assessed and recorded in a study proforma. All the patients matching the inclusion and exclusion criteria, diagnosed clinically and histopathologically with Oral submucous fibrosis with all age ranges and both genders are included in the study sample. Study was explained to all the patients and Informed consent was taken from all, diligently following the Helsinki declaration. The sample size consisted of 45 patients which were divided into 3 groups, 15 patients in each group. First group is subjected to balloon blow exercise and interincisal distance will be measured using vernier caliper before and after the treatment at 2 weeks, 4 weeks 6 weeks and 8 weeks. Second group is subjected to ice- cream exercise and interincisal distance will be measured using vernier caliper before and after the treatment at 2 weeks, 4 weeks 6 weeks and 8 weeks.Third group is subjected to mouth opener device and interincisal distance will be measured using vernier caliper before and after the treatment at 2 weeks, 4 weeks 6 weeks and 8 weeks.The principal investigator carried out the initial as well as periodic evaluations every week of all the participants. |