Oral Health CareNCT07251543
Effects of a Salivary Gland Massage Program on Salivary Flow , Xerostomia, Chewing, and Swallowing, and Oral Health Among Community- Dwelling Older Adults
A study testing Salivary gland massage and General Oral Health Education in people with Oral Health Care, run by Chiayi Christian Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Oral Health Care
- What is being tested?
- Salivary gland massage and General Oral Health Education
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteTaiwan
- Study dates
- 2 Sep 2025to 30 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Ditmanson Medical Foundation Chiayi Christian Hospital
Chiayi City, Taiwan
About this study
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.
Read more
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
- Being tested
- Salivary gland massage, General Oral Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salivary gland massageBehavioural
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 EducationBehavioural
Health Education Presentation and Leaflet, Massage Not Performed
| Study group | Role | What they receive |
|---|---|---|
| Salivary gland massage group | Experimental | salivary gland massage Receives: Behavioral: Salivary gland massage |
| General oral health education group | Other | General oral health education group Receives: Behavioral: General Oral Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 3 months
Oral health
Tongue coating index measurement, If Tongue coating index ≥ 50% or total score ≥ 9, oral hygiene is poor.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start2 Sep 2025
- Primary completion15 Dec 2025 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Health CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiayi Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- I-Chun Chen, AHN, Study director, Ditmanson Medical Foundation Chia-Yi Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07251543
- Sponsor's protocol ID
- IRB2025071
- Status last verified
- Sep 2025
- First submitted
- 11 Aug 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Salivary Gland Massage Program on Salivary Flow , Xerostomia, Chewing, and Swallowing, and Oral Health Among Community- Dwelling Older Adults
- ClinicalTrials.gov ID
- NCT07251543
- Acronym / sponsor ID
- IRB2025071
- Conditions
- Oral Health Care
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Chiayi Christian HospitalUniversity, hospital or other
- Study start
- 2 Sep 2025 (actual)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 26 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Salivary gland massage group | Experimental | Behavioral: Salivary gland massagesalivary gland massage |
| General oral health education group | Other | Behavioral: General Oral Health EducationGeneral oral health education group |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Salivary gland massageParticipants 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. | Behavioural | Salivary gland massage group |
| General Oral Health EducationHealth Education Presentation and Leaflet, Massage Not Performed | Behavioural | General oral health education group |
Primary outcome
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.
4 secondary outcomes
xerostomia
Time frame: 3 months
Oral mucosal moisture measurement
Time frame: 3 months
Swallowing assessment
Time frame: 3 months
Oral health
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
I-Chun Chen, AHN study director
Ditmanson Medical Foundation Chia-Yi Christian Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Salivary gland massage and General Oral Health Education in people with Oral Health Care, run by Chiayi Christian Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unstimulated Salivary Flow Rate (mL/min) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.