| CTRI Number |
CTRI/2026/03/105155 [Registered on: 02/03/2026] Trial Registered Prospectively |
| Last Modified On: |
28/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluating Two Easy Treatments to Increase Saliva in Postmenopausal Women with Dry Mouth |
|
Scientific Title of Study
|
Comparison of TENS and Interferential Therapy in Salivary Stimulation in Post-Menopausal Women with Oral Dryness—A Clinical 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 |
Shalini prabha P |
| Designation |
post graduate |
| Affiliation |
SRM Dental college |
| Address |
Department of Oral Medicine and radiology, ramapuram, Bharathi Salai, 600089
Department of Oral Medicine and radiology, ramapuram, Bharathi Salai, 600089
Chennai
TAMIL NADU
600088
India |
| Phone |
9940702765 |
| Fax |
|
| Email |
shalinishallu40@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anuradha Ganesan |
| Designation |
Professor and Head of the department |
| Affiliation |
SRM Dental college |
| Address |
Department of Oral Medicine and radiology, ramapuram, Bharathi Salai, 600089
Department of Oral Medicine and radiology, ramapuram, Bharathi Salai, 600089
Chennai
TAMIL NADU
600088
India |
| Phone |
09940702765 |
| Fax |
|
| Email |
anug77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shalini prabha P |
| Designation |
post graduate |
| Affiliation |
SRM Dental college |
| Address |
Department of Oral Medicine and radiology, ramapuram, Bharathi Salai, 600089
Department of Oral Medicine and radiology, ramapuram, Bharathi Salai, 600089
Chennai
TAMIL NADU
600089
India |
| Phone |
9940702765 |
| Fax |
|
| Email |
shalinishallu40@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Oral Medicine and Radiology, SRM Dental College, Ramapuram, Bharathi Salai, 600089 |
|
|
Primary Sponsor
|
| Name |
SRM dental college |
| Address |
Department of Oral Medicine and radiology, ramapuram, Bharathi Salai, 600089 |
| Type of Sponsor |
Private medical college |
|
|
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 Shalini Prabha P |
SRM dental college |
Department of oral medicine and radiology , ramapuram , bharathi salai , 600089
Chennai
TAMIL NADU |
9940702765
shalinishallu40@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRMIRB |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
postmenopausal women with oral dryness |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Interferential therapy |
it is an electrotherapy device which is used to stimulate tissues , salivary glands
|
| Comparator Agent |
Transcutaneous electrical nerve stimulation (TENS) |
It is another electrotherapy device used for pain relief or stimulation of tissues |
|
|
Inclusion Criteria
|
| Age From |
45.00 Day(s) |
| Age To |
70.00 Day(s) |
| Gender |
Female |
| Details |
Females aged 45–70 years with history of menopause, Patients with no history of habits, patients with oral dryness,Patients willing for the study
|
|
| ExclusionCriteria |
| Details |
Patients with salivary gland disease/disorders
Patients with History of head and neck cancer and undergoing chemotherapy
Patients with xerostomia due to Sjogren’s syndrome
Patients under medications e.g. Antihypertensives, ACE-inhibitors, calcium channel blockers etc. which alters the salivary flow rate
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Interferential therapy showed better results compared to TENS |
baseline and 3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
20/11/2026 |
| 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="10" |
|
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- 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 [shalinishallu40@gmail.com].
- For how long will this data be available start date provided 08-11-2026 and end date provided 08-11-2034?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
this study is done to evaluate and compare the efficacy of interferential therapy in salivary stimulation in comparison with TENS...I chose post menopausal women from age 45 to 70 with oral dryness and will be randomly assigned to both groups and will receive treatment for 3 to 4 weeks twice a week for 15 minutes and the salivary flow rate post treatment will be collected and checked for which group yielded better results |