ElderNCT06397079
Oral Care Program for Residients in Long-term Care Facility
A study testing Electric toothbrush and Soft bristle toothbrush in people with Elder and Oral Hygiene, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
Trial summary
The aim of this study is to investigate the effectiveness of an oral care program on the oral hygiene for residents in long-term care facility. Read more about this study
- Who is it for?
- Ages 20 to 99 years
- Conditions the study is for
- Elder, Oral Hygiene
- What is being tested?
- Electric toothbrush and Soft bristle toothbrush
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 16 Sep 2024to 16 Dec 2024
- 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 20 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eating by mouth
- Able to express fluently in Chinese after correcting vision and hearing
- Normal hand functions
- Able to follow instructions
- Willing to participate in the study and sign the informed consent
Who cannot join
- Unconsicous
- Diagnosis of dementia and inability to communicate
- Having a tracheostomy tube and nasogastric tube
- Unable to move both upper limbs
- Bedridden
- Vulnerable populations (e.g., political, economic, or socially disadvantaged groups)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Effect on Oral Care Program for Residents in Long-term Care Facility
The aim of this study is to investigate the effectiveness of an oral care program on the oral hygiene for residents in long-term care facility.
Read the detailed description
The study adopts a randomized clinical trial design and utilizes a cross-over design. The main outcomes include assessments of oral health (Oral Health Assessment Tool, Oral Health Impact Profile, Geriatric Oral Health Assessment Index), tongue coating cleanliness (Tongue Coating Index), dental plaque and gum cleanliness (Plaque Index, Gingival Index, Gingival Bleeding Index), and swallowing ability (Eating Assessment Tool, Function Oral Intake Scale, International Dysphagia Diet Standardisation Initiative).
- Conditions
- Elder, Oral Hygiene
- Being tested
- Electric toothbrush, Soft bristle toothbrush
- Keywords
- elder, oral hygiene, long-term care facility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electric toothbrushBehavioural
Teach Bass brushing technique and bursh teeth using electric toothbrush dental hygiene three times a day.
Soft bristle toothbrushBehavioural
Teach Bass brushing technique and bursh teeth using soft bristle toothbrush dental hygiene three times a day.
| Study group | Role | What they receive |
|---|---|---|
| Electric toothbrush | Experimental | Teach Bass brushing technique and use electric toothbrush Receives: Behavioral: Electric toothbrush |
| Soft bristle toothbrush | Active comparator | Teach Bass brushing technique and use soft bristle toothbrush Receives: Behavioral: Soft bristle toothbrush |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral Health Assessment Tool
The Oral Health Assessment Tool is a scale for evaluating oral health. The score ranges is 0 to 16. A higher score indicates a poorer oral health condition.
Measured: Baseline to 4 weeks
Oral Health Impact Profile
The Oral Health Impact Profile assesses the quality of oral health-related life. The score ranges is 0 to 56. A higher score indicates poorer oral health-related quality of life.
Measured: Baseline to 4 weeks
Geriatric Oral Health Assessment Index
The Geriatric Oral Health Assessment Index evaluates oral health for older people. The score ranges is 12 to 60. A higher score indicates better oral health.
Measured: Baseline to 4 weeks
Tongue Coating Index
The Tongue Coating Index assesses tongue cleanliness. The score ranges is 0 to 18. A higher core indicates lower cleanliness of the tongue.
Measured: Baseline to 4 weeks
Plaque Index
Plaque Index assesses amount of dental plaque. The score ranges is 0 to 3. A higher score indicates lower amount of dental plaque.
Measured: Baseline to 4 weeks
Gingival Index
The Gingival Index assesses gingival health. The score ranges is 0 to 3. A higher score indicates poorer gingival health.
Measured: Baseline to 4 weeks
Gingival Bleeding Index
The Gingival Bleeding Index assesses gingival health. The score ranges is 0 to 1. A higher score indicates poorer gingival health.
Measured: Baseline to 4 weeks
Eating Assessment Tool
The Eating Assessment Tool evaluates the degree of swallowing status. The score ranges is 0 to 40. A higher score indicates lower swallowing ability.
Measured: Baseline to 4 weeks
Function Oral lntake Scale
The Functional Oral Intake Scale assesses swallowing ability. The score ranges is 1 to 7. A higher score indicates greater swallowing ability.
Measured: Baseline to 4 weeks
International Dysphagia Diet Standardisation Initiative
The International Dysphagia Diet Standardisation Initiative assesses swallowing ability. The score ranges is 0 to 7. A higher score indicates greater swallowing ability.
Measured: Baseline to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start16 Sep 2024
- Primary completion16 Dec 2024
- Study completion16 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taipei University of Nursing and Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, En-Chi Chiu, National Taipei University of Nursing and Health Sciences
- Investigators
- En-Chi Chiu, PhD, Study director, National Taipei University of Nursing and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06397079
- Sponsor's protocol ID
- CTH-113-3-5-004
- Status last verified
- Sep 2024
- First submitted
- 29 Apr 2024
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Effect on Oral Care Program for Residents in Long-term Care Facility
- ClinicalTrials.gov ID
- NCT06397079
- Acronym / sponsor ID
- CTH-113-3-5-004
- Conditions
- Elder, Oral Hygiene
- Keywords
- elder, oral hygiene, long-term care facility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Taipei University of Nursing and Health SciencesUniversity, hospital or other
- Study start
- 16 Sep 2024 (actual)
- Primary completion
- 16 Dec 2024 (actual)
- Study completion
- 16 Dec 2024 (actual)
- First posted
- 2 May 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 aim of this study is to investigate the effectiveness of an oral care program on the oral hygiene for residents in long-term care facility.
Detailed description
The study adopts a randomized clinical trial design and utilizes a cross-over design. The main outcomes include assessments of oral health (Oral Health Assessment Tool, Oral Health Impact Profile, Geriatric Oral Health Assessment Index), tongue coating cleanliness (Tongue Coating Index), dental plaque and gum cleanliness (Plaque Index, Gingival Index, Gingival Bleeding Index), and swallowing ability (Eating Assessment Tool, Function Oral Intake Scale, International Dysphagia Diet Standardisation Initiative).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electric toothbrush | Experimental | Behavioral: Electric toothbrushTeach Bass brushing technique and use electric toothbrush |
| Soft bristle toothbrush | Active comparator | Behavioral: Soft bristle toothbrushTeach Bass brushing technique and use soft bristle toothbrush |
Who may qualify
- Ages
- 20 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Eating by mouth
- Able to express fluently in Chinese after correcting vision and hearing
- Normal hand functions
- Able to follow instructions
- Willing to participate in the study and sign the informed consent
Key exclusion criteria (6 listed)
- Unconsicous
- Diagnosis of dementia and inability to communicate
- Having a tracheostomy tube and nasogastric tube
- Unable to move both upper limbs
- Bedridden
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 |
|---|---|---|
| Electric toothbrushTeach Bass brushing technique and bursh teeth using electric toothbrush dental hygiene three times a day. | Behavioural | Electric toothbrush |
| Soft bristle toothbrushTeach Bass brushing technique and bursh teeth using soft bristle toothbrush dental hygiene three times a day. | Behavioural | Soft bristle toothbrush |
Primary outcome
Oral Health Assessment Tool
Time frame: Baseline to 4 weeks
The Oral Health Assessment Tool is a scale for evaluating oral health. The score ranges is 0 to 16. A higher score indicates a poorer oral health condition.
Oral Health Impact Profile
Time frame: Baseline to 4 weeks
The Oral Health Impact Profile assesses the quality of oral health-related life. The score ranges is 0 to 56. A higher score indicates poorer oral health-related quality of life.
Geriatric Oral Health Assessment Index
Time frame: Baseline to 4 weeks
The Geriatric Oral Health Assessment Index evaluates oral health for older people. The score ranges is 12 to 60. A higher score indicates better oral health.
Tongue Coating Index
Time frame: Baseline to 4 weeks
The Tongue Coating Index assesses tongue cleanliness. The score ranges is 0 to 18. A higher core indicates lower cleanliness of the tongue.
Plaque Index
Time frame: Baseline to 4 weeks
Plaque Index assesses amount of dental plaque. The score ranges is 0 to 3. A higher score indicates lower amount of dental plaque.
Gingival Index
Time frame: Baseline to 4 weeks
The Gingival Index assesses gingival health. The score ranges is 0 to 3. A higher score indicates poorer gingival health.
Gingival Bleeding Index
Time frame: Baseline to 4 weeks
The Gingival Bleeding Index assesses gingival health. The score ranges is 0 to 1. A higher score indicates poorer gingival health.
Eating Assessment Tool
Time frame: Baseline to 4 weeks
The Eating Assessment Tool evaluates the degree of swallowing status. The score ranges is 0 to 40. A higher score indicates lower swallowing ability.
Function Oral lntake Scale
Time frame: Baseline to 4 weeks
The Functional Oral Intake Scale assesses swallowing ability. The score ranges is 1 to 7. A higher score indicates greater swallowing ability.
International Dysphagia Diet Standardisation Initiative
Time frame: Baseline to 4 weeks
The International Dysphagia Diet Standardisation Initiative assesses swallowing ability. The score ranges is 0 to 7. A higher score indicates greater swallowing ability.
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 5 Jan 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.
En-Chi Chiu, PhD study director
National Taipei University of Nursing and Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electric toothbrush and Soft bristle toothbrush in people with Elder and Oral Hygiene, run by National Taipei University of Nursing and Health Sciences 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 6 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 5 Jan 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 Health Assessment Tool (time frame: Baseline to 4 weeks). The study lists 10 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 5 Jan 2026.