ClinicalTrials.gg
Enrolling by invitationNCT07251543Updated Nov 26, 2025

Effects of a Salivary Gland Massage Program on Salivary Flow , Xerostomia, Chewing, and Swallowing, and Oral Health Among Community- Dwelling Older Adults

An interventional study of Salivary gland massage and General Oral Health Education in Oral Health Care, sponsored by Chiayi Christian Hospital. Enrolling by invitation at 1 site in Taiwan. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-11-26.

Sponsored by Chiayi Christian Hospital · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as enrolling by invitation.
Phase
Not applicable
Study type
Interventional
Enrollment
108
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study summary

Purpose: This study aims to evaluate the effectiveness of salivary gland massage on saliva flow, xerostomia, chewing and swallowing, and oral health among community-dwelling elderly.

Design: A double-blind, randomized controlled trial, in which both participants and interventionists were unaware of group assignments.

Sample and setting: Community-dwelling older adults were recruited from community centers in Minxiong Township and were randomly assigned by center to either the intervention group (n = 54) or the control group (n = 54) using simple randomization.

Methods: the investigators conducted a randomized controlled trial with 108 older adults aged 65 and above from community centers in Chiayi County, Taiwan. Participants were randomly assigned to either an intervention group (n=54), who received guided salivary gland massage, or a control group (n=54), who received a health education leaflet on oral care. Before and after the intervention, the investigators assessed dry mouth symptoms, oral mucosal moisture, The Modified Water Swallowing Test, and Tongue Coating Index. Data were analyzed using SPSS version 22, applying chi-square tests, paired t-tests, independent t-tests, and generalized estimating equations to determine whether the massage intervention could improve saliva production, ease dry mouth, enhance chewing and swallowing functions, and promote better oral health.

Expected Research Benefits: Salivary gland massage is a simple, safe, and self-administered health promotion method. The findings of this study may serve as an intervention strategy for health promotion programs, aiming to enhance oral health and quality of life among community-dwelling older adults, while reducing the healthcare burden associated with oral health problems. Additionally, this approach may strengthen older adults' engagement in preventive health management and increase their willingness to actively manage their own health.

02

Conditions studied

  • Oral Health Care
03

In context

Lead sponsor

Chiayi Christian Hospital is the lead sponsor of 27 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age ≥ 65 years.
  2. Mentally aware and able to express themselves in Mandarin or Taiwanese.
  3. Able to follow instructions and participate in activities.
  4. After the researcher explains the purpose and procedures of the study, they voluntarily participate in the study and sign the form.

Exclusion criteria

Exclusion Criteria:

  1. Elderly individuals with Sjögren's disease, head and neck cancer, tongue disease, or those undergoing radiation therapy or chemotherapy.
  2. Those with cognitive impairment or unable to safely participate in exercise training.
  3. Those unable to provide written .
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
108 participants (estimated)

Study arms

  • Experimental
    Salivary gland massage group

    salivary gland massage

    Behavioral: Salivary gland massage

  • Other
    General oral health education group

    General oral health education group

    Behavioral: General Oral Health Education

Interventions

  • BehavioralSalivary gland massage

    Participants will perform a salivary gland massage before each of their three meals, 10 times per gland, for three cycles, approximately 2 minutes each, for three months.

  • BehavioralGeneral Oral Health Education

    Health Education Presentation and Leaflet, Massage Not Performed

06

What researchers measure

Primary outcomes

  1. Unstimulated Salivary Flow Rate (mL/min)

    Use 4\*4 cm gauze to measure saliva. First, put the gauze into the subject's mouth and ask the subject to chew for two minutes. After two minutes, the gauze is placed in a bag, and any remaining saliva is spat into the bag and weighed. The total collected volume is recorded and converted to a flow rate per minute (mL/min). A normal baseline saliva flow rate is approximately 0.3-0.5 mL/min; a flow rate below 0.1 mL/min may indicate a risk of dry mouth.

    Time frame: 3 months

Secondary outcomes

  1. xerostomia

    The dry mouth condition was measured using the short dry mouth questionnaire, The dry mouth questionnaire consists of 5 questions. The higher the score, the more severe the dry mouth condition.

    Time frame: 3 months

  2. Oral mucosal moisture measurement

    Use an oral moisture meter to measure the wetness of the tongue dorsum mucosa. Ask the subject to stick out his tongue and measure the tongue surface 10 mm away from the tip of the tongue. Perform the measurement three times and calculate the average value.The lower the score, the more severe the dry mouth.

    Time frame: 3 months

  3. Swallowing assessment

    Using a modified water swallowing test, the subject is asked to sit on a chair and swallow 5cc of water. If they can swallow smoothly, they are asked to repeat the swallowing twice and the lowest score is used as the evaluation result.A score of ≤3 indicates a failed test, signifying poor swallowing ability.

    Time frame: 3 months

  4. Oral health

    Tongue coating index measurement, If Tongue coating index ≥ 50% or total score ≥ 9, oral hygiene is poor.

    Time frame: 3 months

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07251543
Lead sponsor
Chiayi Christian Hospital
Responsible party
Sponsor
First posted
Nov 26, 2025
Start date
Sep 2, 2025
Primary completion
Dec 15, 2025 (estimated)
Completion
Aug 30, 2026 (estimated)
Last update
Nov 26, 2025

Study contacts

I-Chun Chen, AHN
study director · Ditmanson Medical Foundation Chia-Yi Christian Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion