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

NCT07251543 | Enrolling By Invitation

• 1 other identifier: IRB2025071
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Oral Health Care

Outcome Measures

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.

  3 months

Secondary Outcomes (4)

• xerostomia

  3 months

• Oral mucosal moisture measurement

  3 months

• Swallowing assessment

  3 months

• Oral health

  3 months

Study Arms (2)

Salivary gland massage group

EXPERIMENTAL

salivary gland massage

Behavioral: Salivary gland massage

General oral health education group

OTHER

General oral health education group

Behavioral: General Oral Health Education

Interventions

Salivary gland massage 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.

Salivary gland massage group

General Oral Health Education BEHAVIORAL

Health Education Presentation and Leaflet, Massage Not Performed

General oral health education group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Elderly individuals with Sjögren's disease, head and neck cancer, tongue disease, or those undergoing radiation therapy or chemotherapy.
• Those with cognitive impairment or unable to safely participate in exercise training.
• Those unable to provide written informed consent.

Sponsors & Collaborators

• Chiayi Christian Hospital: lead

Study Sites (1)

Ditmanson Medical Foundation Chiayi Christian Hospital

Chiayi City, Taiwan, Taiwan

Location

Study Officials

• I-Chun Chen, AHN

  Ditmanson Medical Foundation Chia-Yi Christian Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Seed personnel
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: November 26, 2025
• Study Start: September 2, 2025
• Primary Completion: December 15, 2025
• Study Completion (Estimated): August 30, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)