Oral HealthNCT06529900
The Effects of Technological Oral Health Management
A study testing oral mastication training and texture and diet education in people with Oral Health and Malnutrition, run by Chang Gung University of Science and Technology at 1 site in Taiwan.
Trial summary
The goal of interventional study is to for the elderly who have poor chewing and eating ability after installing removable dentures through the intervention of oral mastication training and texture and diet education, the effects on oral health, eating ability, nutrition, and physical function changes are confirmed in… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Oral Health, Malnutrition, Dysphagia
- What is being tested?
- oral mastication training and texture and diet 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
- 61 participants
- Where
- 1 siteTaiwan
- Study dates
- 13 Sep 2024to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- residing in Chiayi County who are 65 years of age or older
- capable of self-care, conscious
- able to communicate in Mandarin and Taiwanese.
Who cannot join
- non-residents of Chiayi County
- unable to take care of themselves or are unconscious
- demented or mentally challenged and are unable to cooperate
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Chang Gung University of Science and Technology, Chiayi Campus
Chiayi City
About this study
Official title: The Effects of Technological Oral Health Management on Improving Oral Health, Eating Ability, Nutritional Status, and Physical Function of the Elderly in the Community After Wearing Removable Dentures: An Example of the Agricultural County
The goal of interventional study is to for the elderly who have poor chewing and eating ability after installing removable dentures through the intervention of oral mastication training and texture and diet education, the effects on oral health, eating ability, nutrition, and physical function changes are confirmed in Elderly individuals residing in Chiayi County who are 65 years of age or older, capable of self-care, conscious, and able to communicate in Mandarin and Taiwanese. The main question it aims to answer is:
•Are there significant benefits to oral health, eating ability, nutrition, and physical function through the intervention of oral mastication training and texture and diet education? Researchers will compare changes in oral health, eating ability, nutrition, and physical functioning results to see if oral mastication training is effective.
Read more
Participants will:
- Experimental group: oral mastication training and texture and diet education.
- Control group: only texture and diet education.
- Cases were tracked in month 1 and will be tracked again in month 6.
Read the detailed description
Expected Results：
- To establish an oral mastication training and texture and diet education program for the elderly who have poor chewing and eating ability after dentures are installed.
- Provide teaching programs tailored to the evidence-based and individualized needs of the elderly.
- Through the implementation of evidence-based oral mastication training and a texture and diet education program, the experimental group and the control group are expected to show variations in oral health, eating ability, nutrition, and physical function over time.
- Conditions
- Oral Health, Malnutrition, Dysphagia, Sarcopenia
- Being tested
- oral mastication training, texture and diet education
- Keywords
- the elderly in the community, oral health, nutrition, eating ability, physical function, technological oral health management, dentures
- Medical subject headings
- Malnutrition, Deglutition Disorders, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral mastication trainingBehavioural
Through specific exercises and techniques aimed at enhancing masticatory function and overall oral health.
texture and diet educationBehavioural
Teach the knowledge and techniques of softening food textures.
| Study group | Role | What they receive |
|---|---|---|
| Oral Mastication Training and Texture and Diet Education | Experimental | Participants in this arm will receive oral mastication training combined with texture and diet education. Receives: Behavioral: oral mastication training; Behavioral: texture and diet education |
| Texture and Diet Education | Active comparator | Participants in this arm will receive texture and diet education without the oral mastication training component. Receives: Behavioral: texture and diet education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral Frailty Index-8
The total score was 11 points. 0-2 points: low risk, 3 points: medium risk, and 4 points or above: high risk.
Measured: Baseline, 1 month, 6 months.
Iowa Oral Performance Instrument
It is considered abnormal for values below the 5th percentile.
Measured: Baseline, 1 month, 6 months.
Food Intake Questionnaire
A subject with four or more 'difficult-to-eat' responses to the 14-food group questionnaire would be classified as abnormal.
Measured: Baseline, 1 month, 6 months.
Comfort Eating Scale
On a scale of 1 to 10, where 1 represents very good (no impact, no pain) and 10 represents very bad (impact, pain).
Measured: Baseline, 1 month, 6 months.
Mini Nutritional Assessment-Short Form
0 - 7 points: malnourished; 8 - 11 points: at risk of malnutrition; or 12 - 14 points: well-nourished.
Measured: Baseline, 1 month, 6 months.
Study of Osteoporotic Fracture
One component was considered to be in a pre-frailty state, while two or more components indicated frailty.
Measured: Baseline, 1 month, 6 months.
Handgrip strength
Weak hand grip strength was defined as < 26 kg for men and < 18 kg for women.
Measured: Baseline, 1 month, 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start13 Sep 2024
- Primary completion31 Jul 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral HealthStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kuo Ya-Wen, Chang Gung University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06529900
- Sponsor's protocol ID
- 111-670
- Status last verified
- Oct 2026
- First submitted
- 22 Jul 2024
- Last updated
- 22 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Technological Oral Health Management on Improving Oral Health, Eating Ability, Nutritional Status, and Physical Function of the Elderly in the Community After Wearing Removable Dentures: An Example of the Agricultural County
- ClinicalTrials.gov ID
- NCT06529900
- Acronym / sponsor ID
- 111-670
- Conditions
- Oral Health, Malnutrition, Dysphagia, Sarcopenia
- Keywords
- the elderly in the community, oral health, nutrition, eating ability, physical function, technological oral health management, dentures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Chang Gung University of Science and TechnologyUniversity, hospital or other
- Study start
- 13 Sep 2024 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 31 Jul 2024 (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.
The goal of interventional study is to for the elderly who have poor chewing and eating ability after installing removable dentures through the intervention of oral mastication training and texture and diet education, the effects on oral health, eating ability, nutrition, and physical function changes are confirmed in Elderly individuals residing in Chiayi County who are 65 years of age or older, capable of self-care, conscious, and able to communicate in Mandarin and Taiwanese. The main question it aims to answer is:
•Are there significant benefits to oral health, eating ability, nutrition, and physical function through the intervention of oral mastication training and texture and diet education? Researchers will compare changes in oral health, eating ability, nutrition, and physical functioning results to see if oral mastication training is effective.
Participants will:
- Experimental group: oral mastication training and texture and diet education.
- Control group: only texture and diet education.
- Cases were tracked in month 1 and will be tracked again in month 6.
Detailed description
Expected Results：
- To establish an oral mastication training and texture and diet education program for the elderly who have poor chewing and eating ability after dentures are installed.
- Provide teaching programs tailored to the evidence-based and individualized needs of the elderly.
- Through the implementation of evidence-based oral mastication training and a texture and diet education program, the experimental group and the control group are expected to show variations in oral health, eating ability, nutrition, and physical function over time.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Mastication Training and Texture and Diet Education | Experimental | Behavioral: oral mastication training, Behavioral: texture and diet educationParticipants in this arm will receive oral mastication training combined with texture and diet education. |
| Texture and Diet Education | Active comparator | Behavioral: texture and diet educationParticipants in this arm will receive texture and diet education without the oral mastication training component. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- residing in Chiayi County who are 65 years of age or older
- capable of self-care, conscious
- able to communicate in Mandarin and Taiwanese.
Key exclusion criteria (3 listed)
- non-residents of Chiayi County
- unable to take care of themselves or are unconscious
- demented or mentally challenged and are unable to cooperate
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 |
|---|---|---|
| oral mastication trainingThrough specific exercises and techniques aimed at enhancing masticatory function and overall oral health. | Behavioural | Oral Mastication Training and Texture and Diet Education |
| texture and diet educationTeach the knowledge and techniques of softening food textures. | Behavioural | Oral Mastication Training and Texture and Diet Education, Texture and Diet Education |
Primary outcome
Oral Frailty Index-8
Time frame: Baseline, 1 month, 6 months.
The total score was 11 points. 0-2 points: low risk, 3 points: medium risk, and 4 points or above: high risk.
Iowa Oral Performance Instrument
Time frame: Baseline, 1 month, 6 months.
It is considered abnormal for values below the 5th percentile.
Food Intake Questionnaire
Time frame: Baseline, 1 month, 6 months.
A subject with four or more 'difficult-to-eat' responses to the 14-food group questionnaire would be classified as abnormal.
Comfort Eating Scale
Time frame: Baseline, 1 month, 6 months.
On a scale of 1 to 10, where 1 represents very good (no impact, no pain) and 10 represents very bad (impact, pain).
Mini Nutritional Assessment-Short Form
Time frame: Baseline, 1 month, 6 months.
0 - 7 points: malnourished; 8 - 11 points: at risk of malnutrition; or 12 - 14 points: well-nourished.
Study of Osteoporotic Fracture
Time frame: Baseline, 1 month, 6 months.
One component was considered to be in a pre-frailty state, while two or more components indicated frailty.
Handgrip strength
Time frame: Baseline, 1 month, 6 months.
Weak hand grip strength was defined as < 26 kg for men and < 18 kg for women.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral mastication training and texture and diet education in people with Oral Health and Malnutrition, run by Chang Gung University of Science and Technology 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 3 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: finished, as of the sponsor's last update on 22 Oct 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Oral Frailty Index-8 (time frame: Baseline, 1 month, 6 months.). The study lists 7 primary outcomes in all. 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 22 Oct 2026.