| CTRI Number |
CTRI/2025/12/099260 [Registered on: 16/12/2025] Trial Registered Prospectively |
| Last Modified On: |
15/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Investigating salivary gland Massage as a Treatment for Dry Mouth and Its Effects of oral comfort and oral health related quality of life among elderly |
|
Scientific Title of Study
|
Assessing the effectiveness of salivary gland massage
on oral dryness and its impact on oral frailty and OHRQoL – 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 |
Saranya J Prakash |
| Designation |
Postgraduate |
| Affiliation |
Chettinad dental college and research institute |
| Address |
room-3, 1st floor, department of public health dentistry, Chettinad health city, Rajivgandhi express highway , old Mahaballipuram road
Chennai
TAMIL NADU
603103
India |
| Phone |
8807686745 |
| Fax |
|
| Email |
saranyajp1411@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jagannatha G V |
| Designation |
professor and head |
| Affiliation |
Chettinad dental college and research institute |
| Address |
room-3, 1st floor, department of public health dentistry, Chettinad health city, Rajivgandhi express highway , old Mahaballipuram road
Chennai
TAMIL NADU
603103
India |
| Phone |
9900219977 |
| Fax |
|
| Email |
drjagannathmds@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jagannatha G V |
| Designation |
professor and head |
| Affiliation |
Chettinad dental college and research institute |
| Address |
room-3, 1st floor, department of public health dentistry, Chettinad health city, Rajivgandhi express highway , old Mahaballipuram road
Chennai
TAMIL NADU
603103
India |
| Phone |
9900219977 |
| Fax |
|
| Email |
drjagannathmds@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Saranya J Prakash |
| Address |
room-3, 1st floor, department of public health dentistry, Chettinad dental college college and research institute, Rajiv Gandhi salai, old Mahabalipuram road, kelambakkam - 603103 |
| 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 |
| Rani krishnan |
Annai fathima welfare center |
No: 48, Old Mahabalipuram Road, Karapakkam, Chennai, Tamil Nadu 600097
Chennai
TAMIL NADU |
9444444874
ranikrishnan06@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee Chettinad Dental College and Research Institute (IHEC-CDCRI) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K117||Disturbances of salivary secretion, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
salivary gland massage |
participants were taught with the salivary gland massage. poster with salivary gland massage instructions will be given to them. patients will be instructed to do the massage everyday before each meal |
| Comparator Agent |
standard care and oral hygiene instructions |
Standard care consisted of lifestyle modifications, including frequent hydration, nocturnal humidification, and the use of water-based lip moisturizers. Patients were counseled to avoid dehydrating or irritating substances (caffeine, alcohol, tobacco, spicy foods) and received education on the causes and complications of xerostomia. oral hygiene instructions given |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Elderly Participants of aged 60 years and above (both males and females) with self reported oral dryness and who are able to understand the study procedures and able to tolerate gentle massage of facial and jaw region were included. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| salivary flow rate, oral health related quality of life and oral frailty |
salivary flow rate |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| oral health related quality of life and oral frailty |
base line, after 15 days and after 30 days |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
Final Enrollment numbers achieved (Total)= "66"
Final Enrollment numbers achieved (India)="66" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
19/01/2026 |
| Date of Study Completion (India) |
24/03/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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 - NO
|
|
Brief Summary
|
This parallel randomized controlled trial aims to evaluate the efficacy of daily salivary gland massage in mitigating oral dryness and its subsequent impact on oral frailty and oral health-related quality of life among institutionalized elderly individuals. The study addresses the high prevalence of xerostomia in the geriatric population, which contributes to functional decline and nutritional issues, by proposing a low-cost, non-pharmacological intervention. the research will involve aged 60 and above institutionalized individuals who have self-reported oral dryness. These participants will be randomly allocated into two groups: an intervention group performing daily salivary gland massage alongside oral hygiene instructions, and a control group receiving only oral hygiene instructions. Over a one-month duration, the study will track the primary outcome of salivary flow rate using the Oral Schirmer’s test, alongside secondary outcomes including oral frailty (OFI-8), and oral health related quality of life (GOHAI), with data collected at baseline, 15 days, and 30 days. |