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

NCT ID: NCT07251543

Last Updated: 2025-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-02

Study Completion Date

2026-08-30

Brief Summary

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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.

Detailed Description

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Conditions

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Oral Health Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Seed personnel

Study Groups

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Salivary gland massage group

salivary gland massage

Group Type EXPERIMENTAL

Salivary gland massage

Intervention Type BEHAVIORAL

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.

General oral health education group

General oral health education group

Group Type OTHER

General Oral Health Education

Intervention Type BEHAVIORAL

Health Education Presentation and Leaflet, Massage Not Performed

Interventions

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Salivary 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.

Intervention Type BEHAVIORAL

General Oral Health Education

Health Education Presentation and Leaflet, Massage Not Performed

Intervention Type BEHAVIORAL

Eligibility Criteria

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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 informed consent form.

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 informed consent.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chiayi Christian Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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I-Chun Chen, AHN

Role: STUDY_DIRECTOR

Ditmanson Medical Foundation Chia-Yi Christian Hospital

Locations

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Ditmanson Medical Foundation Chiayi Christian Hospital

Chiayi City, Taiwan, Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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IRB2025071

Identifier Type: -

Identifier Source: org_study_id

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