DementiaNCT07401693
The Effect of Oral Health Care Program on Oral Hygiene and Oral Function for the Elderly Patient With Dementia in Day Care Center
A study testing Oral Health Care Program in people with Dementia and Oral Health Care, run by Shiou-fang Lu at 1 site in Taiwan.
Trial summary
This study evaluated the effects of an oral health care program on oral hygiene and oral function in older adults with dementia attending a day care center. Participants received a structured oral health care intervention, and changes in oral hygiene and oral function were assessed over a 4-week follow-up period. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Dementia, Oral Health Care, Oral Hygiene
- What is being tested?
- Oral Health Care Program
- 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
- 64 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Jul 2023to 21 Oct 2023
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 60 years or older.
- Diagnosed with dementia by a physician.
- Attending a day care center.
- Able to participate in the oral health care program and assessments.
- Provided informed consent from the participant or a legally authorized representative
Who cannot join
- Presence of acute medical conditions that would interfere with participation.
- Severe physical or mental conditions that prevent completion of the intervention or outcome assessments.
- Refusal or inability to provide informed consent.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Mennonite Christian Hospital Shoufeng Branch Day Care Center
Hualien City, Hualien County, 974
About this study
This study evaluated the effects of an oral health care program on oral hygiene and oral function in older adults with dementia attending a day care center. Participants received a structured oral health care intervention, and changes in oral hygiene and oral function were assessed over a 4-week follow-up period. The goal of this study was to explore whether a structured oral health care program could help improve oral health outcomes in older adults with dementia in a day care setting.
Read the detailed description
This study employed a quasi-experimental design to examine the effects of an oral health care program on oral hygiene and oral function among older adults with dementia attending a day care center. Participants received a structured oral health care intervention designed to promote oral hygiene practices and oral functional ability. Outcome measures related to oral hygiene and oral function were assessed at baseline and at 4 weeks after the intervention. This study aimed to provide evidence on the effectiveness of an oral health care program for improving oral health outcomes in older adults with dementia in a day care setting.
- Conditions
- Dementia, Oral Health Care, Oral Hygiene
- Being tested
- Oral Health Care Program
- Keywords
- Dementia, Oral hygiene, Day care center, Older adults, oral care intervention, oral function
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Health Care ProgramBehavioural
A structured oral health care program designed to improve oral hygiene and oral function among older adults with dementia attending a day care center. The program included guided oral exercises and daily oral hygiene practices delivered over a 4-week period.
| Study group | Role | What they receive |
|---|---|---|
| Oral Health Care Program | Experimental | Participants assigned to the intervention group received a structured oral health care program designed to improve oral hygiene and oral function. Outcome measures were assessed at baseline and at 4 weeks after the intervention. Receives: Behavioral: Oral Health Care Program |
| Usual Care (Waiting-list Control) | No intervention | Participants assigned to the control (waiting-list) group did not receive the oral health care intervention during the study period and continued with usual care. Outcome measures were assessed at baseline and at 4 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral hygiene
Oral hygiene was assessed using the Oral Health Assessment Tool (OHAT) as the primary outcome measure. OHAT is a validated composite scale with a total score ranging from 0 to 16, with higher total scores indicating poorer oral health status.
Measured: From baseline to 4 weeks after intervention
Oral function
Oral function was assessed using standardized functional assessments to evaluate changes in oral motor and swallowing function following the oral care intervention. Higher scores or values indicate better oral or swallowing function.
Measured: From baseline to 4 weeks after intervention
Secondary outcomes (6)
Plaque index
Dental plaque accumulation was assessed using the Plaque Index, which evaluates the thickness of dental plaque at the gingival area. Scores range from 0 to 3, with higher scores indicating greater plaque accumulation and poorer oral hygiene.
Measured: From baseline to 4 weeks after intervention
Tongue coating index
Tongue coating was assessed using the Tongue Coating Index, with scores ranging from 0 to 2. A lower score indicates less tongue coating and better oral hygiene.
Measured: From baseline to 4 weeks after intervention.
Puff cheeks
The ability to puff the cheeks was assessed using a functional scoring scale ranging from 0 to 5, where 0 indicates inability to puff the cheeks, 3 indicates barely able to puff the cheeks, and 5 indicates the ability to puff both cheeks. Higher scores indicate better oral function.
Measured: From baseline to 4 weeks after intervention.
Choke
Swallowing ability was assessed using a choking frequency scale ranging from 0 to 5, where 0 indicates tube feeding, 1 indicates frequent choking, 3 indicates occasional choking, and 5 indicates almost no choking. Higher scores indicate better swallowing function.
Measured: From baseline to 4 weeks after intervention.
Repetitive Saliva Swallowing Test (RSST)
Have the subject sit. The examiner gently places their fingertip on the subject's Adam's apple or hyoid bone and instructs the subject to swallow saliva. The examiner can feel the Adam's apple rise and then return to its original position. If the subject experiences dry mouth, about 1 cc of water can be given. Observe this action for 30 seconds and record the number of swallows obtained through palpation.The Repetitive Saliva Swallowing Test (RSST) was used to assess swallowing function by counting the number of saliva swallows within 30 seconds. Higher values indicate better swallowing ability.
Measured: From baseline to 4 weeks after intervention.
Oral DDK rate(times/10')
Oral diadochokinetic (DDK) rate was assessed by counting the number of syllable repetitions produced within 10 seconds. Higher values indicate better oral motor function.
Measured: From baseline to 4 weeks after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start20 Jul 2023
- Primary completion21 Oct 2023
- Study completion21 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were assigned to either an intervention group or a control (waiting-list) group. The intervention group received the oral health care program, while the control group did not receive the intervention during the study period. Outcomes were assessed at baseline and at 4 weeks after the intervention.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shiou-fang Lu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shiou-fang Lu, Tzu Chi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07401693
- Sponsor's protocol ID
- IRB23-01-003
- Status last verified
- Feb 2026
- First submitted
- 26 Jan 2026
- Last updated
- 10 Feb 2026
- 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 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oral Health Care Program on Oral Hygiene and Oral Function for the Elderly Patient With Dementia in Day Care Center
- ClinicalTrials.gov ID
- NCT07401693
- Acronym / sponsor ID
- IRB23-01-003
- Conditions
- Dementia, Oral Health Care, Oral Hygiene
- Keywords
- Dementia, Oral hygiene, Day care center, Older adults, oral care intervention, oral function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Shiou-fang LuUniversity, hospital or other
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- 21 Oct 2023 (actual)
- Study completion
- 21 Oct 2023 (actual)
- First posted
- 10 Feb 2026 (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.
This study evaluated the effects of an oral health care program on oral hygiene and oral function in older adults with dementia attending a day care center. Participants received a structured oral health care intervention, and changes in oral hygiene and oral function were assessed over a 4-week follow-up period. The goal of this study was to explore whether a structured oral health care program could help improve oral health outcomes in older adults with dementia in a day care setting.
Detailed description
This study employed a quasi-experimental design to examine the effects of an oral health care program on oral hygiene and oral function among older adults with dementia attending a day care center. Participants received a structured oral health care intervention designed to promote oral hygiene practices and oral functional ability. Outcome measures related to oral hygiene and oral function were assessed at baseline and at 4 weeks after the intervention. This study aimed to provide evidence on the effectiveness of an oral health care program for improving oral health outcomes in older adults with dementia in a day care setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were assigned to either an intervention group or a control (waiting-list) group. The intervention group received the oral health care program, while the control group did not receive the intervention during the study period. Outcomes were assessed at baseline and at 4 weeks after the intervention.
| Arm | Type | Receives |
|---|---|---|
| Oral Health Care Program | Experimental | Behavioral: Oral Health Care ProgramParticipants assigned to the intervention group received a structured oral health care program designed to improve oral hygiene and oral function. Outcome measures were assessed at baseline and at 4 weeks after the intervention. |
| Usual Care (Waiting-list Control) | No intervention | –Participants assigned to the control (waiting-list) group did not receive the oral health care intervention during the study period and continued with usual care. Outcome measures were assessed at baseline and at 4 weeks. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 60 years or older.
- Diagnosed with dementia by a physician.
- Attending a day care center.
- Able to participate in the oral health care program and assessments.
- Provided informed consent from the participant or a legally authorized representative
Key exclusion criteria (3 listed)
- Presence of acute medical conditions that would interfere with participation.
- Severe physical or mental conditions that prevent completion of the intervention or outcome assessments.
- Refusal or inability to provide 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 |
|---|---|---|
| Oral Health Care ProgramA structured oral health care program designed to improve oral hygiene and oral function among older adults with dementia attending a day care center. The program included guided oral exercises and daily oral hygiene practices delivered over a 4-week period. | Behavioural | Oral Health Care Program |
Primary outcome
Oral hygiene
Time frame: From baseline to 4 weeks after intervention
Oral hygiene was assessed using the Oral Health Assessment Tool (OHAT) as the primary outcome measure. OHAT is a validated composite scale with a total score ranging from 0 to 16, with higher total scores indicating poorer oral health status.
Oral function
Time frame: From baseline to 4 weeks after intervention
Oral function was assessed using standardized functional assessments to evaluate changes in oral motor and swallowing function following the oral care intervention. Higher scores or values indicate better oral or swallowing function.
6 secondary outcomes
Plaque index
Time frame: From baseline to 4 weeks after intervention
Tongue coating index
Time frame: From baseline to 4 weeks after intervention.
Puff cheeks
Time frame: From baseline to 4 weeks after intervention.
Choke
Time frame: From baseline to 4 weeks after intervention.
Repetitive Saliva Swallowing Test (RSST)
Time frame: From baseline to 4 weeks after intervention.
Oral DDK rate(times/10')
Time frame: From baseline to 4 weeks after intervention.
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 10 Feb 2026.
- 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. 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 Health Care Program in people with Dementia and Oral Health Care, run by Shiou-fang Lu 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 5 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 10 Feb 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 hygiene (time frame: From baseline to 4 weeks after intervention). The study lists 2 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 10 Feb 2026.