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NCT Number: NCT07251543

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.

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Key information

Conditions

Oral Health Care

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ditmanson Medical Foundation Chiayi Christian Hospital

Chiayi City, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

General Oral Health Education

Behavioral

Health Education Presentation and Leaflet, Massage Not Performed

Primary outcomes

  1. Unstimulated Salivary Flow Rate (mL/min)

    Time frame: 3 months

    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.

Secondary outcomes

  1. xerostomia

    Time frame: 3 months

    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.

  2. Oral mucosal moisture measurement

    Time frame: 3 months

    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. Swallowing assessment

    Time frame: 3 months

    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.

  4. Oral health

    Time frame: 3 months

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

Sponsors and collaborators

Lead sponsor

Chiayi Christian Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Nov 26, 2025
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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