| CTRI Number |
CTRI/2025/07/090858 [Registered on: 14/07/2025] Trial Registered Prospectively |
| Last Modified On: |
11/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
EVALUATION AND COMPARISON OF THE EFFECTIVENESS OF SUGAR FREE
CHEWING GUM V/S TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION
(TENS) IN PATIENTS WITH
ORAL SUBMUCOUS FIBROSIS FOR INCREASING MOUTH OPENING AND SALIVARY FLOW RATE |
|
Scientific Title of Study
|
EVALUATION AND COMPARISON OF THE EFFECTIVENESS OF SUGAR FREE
CHEWING GUM V/S TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION
(TENS) IN MOUTH OPENING AND SALIVARY FLOW RATE IN PATIENTS WITH
OSMF – A RANDOMIZED CONTROLLED 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 |
Dr Ajita Mehendale |
| Designation |
Post Graduate Student |
| Affiliation |
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Hingna , Nagpur |
| Address |
Room No.03, Department of Oral Medicine and Radiology, Ground floor,Swargiya DadaSaheb Smruti Dental College and Hospital, Hingna, Nagpur, Maharashtra
Nagpur
MAHARASHTRA
441110
India |
| Phone |
07028432297 |
| Fax |
|
| Email |
ajita.mehendale004@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashish Lanjekar |
| Designation |
Professor and Head of the Department |
| Affiliation |
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Hingna , Nagpur |
| Address |
03, Department of Oral Medicine and Radiology, Ground floor,Swargiya DadaSaheb Smruti Dental College and Hospital, Hingna, Nagpur, Maharashtra
Nagpur
MAHARASHTRA
441110
India |
| Phone |
9595052481 |
| Fax |
|
| Email |
ashish.lanjekar@sdk-dentalcollege.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajita Mehendale |
| Designation |
Post Graduate Student |
| Affiliation |
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Hingna , Nagpur |
| Address |
03, Department of Oral Medicine and Radiology, Ground floor,Swargiya DadaSaheb Smruti Dental College and Hospital, Hingna, Nagpur, Maharashtra
Nagpur
MAHARASHTRA
441110
India |
| Phone |
07028432297 |
| Fax |
|
| Email |
ajita.mehendale004@gmail.com |
|
|
Source of Monetary or Material Support
|
| Swargiya DadaSaheb Kalmegh Smruti Dental College and Hospital, Hingna, Nagpur-441110, Maharashtra,India |
|
|
Primary Sponsor
|
| Name |
Dr Ajita Mehendale |
| Address |
Swargiya DadaSaheb Kalmegh Smruti Dental College and Hospital, Hingna, Nagpur-441110, Maharashtra,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 Ajita Mehendale |
Swargiya DadaSaheb Kalmegh Smruti Dental College and Hospital, Hingna, Nagpur |
03, Department of Oral Medicine and Radiology, Ground Floor,Swargiya DadaSaheb Kalmegh Smruti Dental College and Hospital ,Hingna , Nagpur,Maharashtra
Nagpur
MAHARASHTRA |
07028432297
ajita.mehendale004@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Swargiya DadaSaheb Kalmegh Smruti Dental College and Hospital, Hingna ,Nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services, (2) ICD-10 Condition: K135||Oral submucous fibrosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Sugar free chewing gum |
Sugar free chewing gum includes Xylitol. Xylitol is a natural sweetener found in some berries, fruits, vegetables.Chewing sugar free gums after eating or drinking can increase the flow of saliva and helps reducing the symptoms of dry mouth and bad breath also helps in prevention of caries as xylitol is caries inhibitory, that is, it has anti-cariogenic effect. Also, while chewing chewing gum there will be exercise of the muscles leading to breakdown of fibrous bands in buccal mucosa which will in turn increase the mouth opening and will also induce secretion of saliva leading to increase in salivary flow rate. |
| Comparator Agent |
TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION (TENS) |
Transcutaneous Electrical Nerve Stimulation (TENS) is an established physical therapy useful for relieving pain and induces salivary secretions. this stimulation will lead to increase in salivary flow rate and also can help in increasing mouth opening in patients with OSMF. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Oral submucous fibrosis stage II according to Chandramani More et al 2011 Classification
Patients those are willing to participate |
|
| ExclusionCriteria |
| Details |
Patients with Oral submucous fibrosis stage I,III,IV
Patients with History of systemic disease and taking medications for the same.
Patients less than 18 years of age.
Patients having oral submucous fibrosis without oral burning sensation and altered taste perception. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the increase in mouth opening and salivary flow rate in patients with Submucous Fibrosis also to check the burning mouth and altered taste sensation. |
baseline, after 1 month, after 2 months, after 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the increase in mouth opening and salivary flow rate in patients with Submucous Fibrosis also to check the burning mouth and altered taste sensation with Sugar free chewing gum and transcutaneous electrical nerve stimulation |
baseline, after 1 month, after 2 months, after 3 months |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
22/07/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Introduction - The most common chronic condition and potentially malignant disorder of oral mucosa is Oral sub mucous fibrosis (OSMF). The signs and symptoms of OSMF include blanching of the oral mucosa, burning sensation of the oral mucosa, reduced mouth opening, palpable fibrous bands which involves buccal mucosa, labial mucosa, tongue, floor of mouth and soft palate. A fibrous band that restricts mouth opening (trismus) is a characteristic feature.
Sugar free chewing gum can increase mouth opening and salivary flow rate when compared with trans cutaneous electrical nerve stimulation.
A randomized controlled trial will evaluate and compare sugar free chewing gum and transcutaneous nerve stimulation for increasing mouth opening and salivary flow rate.
Primary objective - | To evaluate the effectiveness of Sugar Free Chewing Gum vs TENS in patients with Oral Submucous Fibrosis with reduced mouth opening, decrease in salivary flow rate, burning mouth and altered taste sensation. Secondary objective - To compare the effectiveness of Sugar Free Chewing Gum vs TENS in patients with Oral Submucous Fibrosis with reduced mouth opening, decrease in salivary flow rate, burning mouth and altered taste sensation.
Methodology - Group A (32 patients) will be given intralesional therapy along with Sugar Free Chewing Gum and mouth opening exercises for a period of 3 months. Group B (32 patients) will be given Intralesional therapy giving Inj. Dexamethasone 4mg/ml, Hyaluronidase 1500 IU and 2%Lignocaine 2ml along with TENS and mouth opening exercises for a period of 3 months.
Evaluation will be done at baseline , after 1 month , after 2 months and after 3 months of follow up.
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