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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Oral Health Care
• Intervention / Treatment: Behavioral: Salivary gland massage; Behavioral: General Oral Health Education

• Study Type: Interventional
• Enrollment (Estimated): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taiwan
    • Chiayi City, Taiwan, Taiwan
      • Ditmanson Medical Foundation Chiayi Christian Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Salivary gland massage group; salivary gland massage	Behavioral: 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.
Other: General oral health education group	Behavioral: General Oral Health Education; Health Education Presentation and Leaflet, Massage Not Performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months
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.	3 months
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.	3 months
Oral health	Tongue coating index measurement, If Tongue coating index ≥ 50% or total score ≥ 9, oral hygiene is poor.	3 months

Collaborators and Investigators

• Sponsor: Chiayi Christian Hospital
• Investigators: Study Director: I-Chun Chen, AHN, Ditmanson Medical Foundation Chia-Yi Christian Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2025
• Primary Completion (Estimated): December 15, 2025
• Study Completion (Estimated): August 30, 2026

Study Registration Dates

• First Submitted: August 11, 2025
• First Submitted That Met QC Criteria: November 19, 2025
• First Posted (Actual): November 26, 2025

Study Record Updates

• Last Update Posted (Actual): November 26, 2025
• Last Update Submitted That Met QC Criteria: November 19, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: IRB2025071

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No