Mild DementiaNCT04390750

Care Partner Assisted Intervention to Improve Oral Health of Individuals With Mild Dementia

A study testing Care Partner-Assisted Intervention in people with Mild Dementia, run by New York University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 60 years and older
Conditions the study is for: Mild Dementia
What is being tested?: Care Partner-Assisted Intervention
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: 60 participants
Where: 2 sitesUnited States
Study dates: 22 Oct 2021to 25 Mar 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

a diagnosis of mild dementia
have at least 4 natural teeth
60 years and older
living with an informal caregiver (i.e. care partner) who is age 18 or older and is willing to participate in the intervention
community-dwelling and physically able to brush own teeth
We will use the following guidelines to identify those with mild dementia: a) a diagnosis of dementia by a physician with dementia expertise within the past year, b) from medical records, a recent Montreal Cognitive Assessment (MoCA) score > 14 or a Mini-Mental Status Examination (MMSE) score > 16, and c) can follow 2 to 3-step commands

Who cannot join

unable to have an oral health evaluation
prescribed antibiotics prior to a regular dental visit
has sensory or physical problems that prevent participation in the intervention
has a terminal illness or behavioral or psychiatric disorder that would interfere with participation in the intervention
has a medical condition such as serious congenital heart conditions, previous infective endocarditis, prosthetic cardiac valves, and cardiac transplantation with cardiac valvulopathy that places him/her at greater risk of infection from the manipulation of the gums to measure the gingival index
has a medical condition that suppresses the immune system
has had a total joint replacement and has had an infection in the replaced joint
is at increased risk of bleeding due to bleeding disorder such as hemophilia or the use of anti-platelet therapy

Trial locations and contacts

2 sites in 1 country.

United States2 sites

North Carolina (Participants Homes)
Durham, North Carolina, 27708
New York City (Participants Homes)
New York, New York, 10010

Other trials in United States

About this study

Care Partner Assisted Intervention to Improve Oral Health for Individuals with Mild Dementia is a randomized control trial (RCT) based in New York City and North Carolina. The intervention includes both a tailored oral care plan and a behavioral component using the Adaptive Leadership Framework for Chronic Illness that the team introduced to manage symptoms associated with chronic conditions, such as dementia. Objective 1 is to evaluate the efficacy of an intervention to improve oral hygiene clinical outcomes (i.e. plaque index and gingival index) by improving oral hygiene behavior (i.e., frequency and duration of toothbrushing) and oral health skills among individuals with mild dementia. Objective 2A is to determine whether effects of the intervention on oral hygiene behavioral outcomes, are mediated by the following variables from the care partners' perspective: 1) oral care self-efficacy; 2) care partner self-efficacy; 3) use of cueing methods; 4) and FOCUSED Communication. Objective 2B is to determine whether effects of the intervention on oral hygiene clinical outcomes, are mediated by the following variables from the care partner's perspective: 1) oral care self-efficacy; 2) care partner's self-efficacy; 3) use of cueing methods; 4) and FOCUSED Communication. Objective 3A is to determine whether effects of the intervention on oral hygiene clinical outcomes are mediated by oral hygiene behavioral outcomes. Objective 3B is to determine whether effects of the intervention on oral hygiene clinical outcomes are mediated by the care partner's factors, which then mediate the oral hygiene behavioral outcomes on oral hygiene clinical outcomes. This innovative care partner-assisted oral care behavior intervention will assist participants and care partners in implementing a cooperative oral hygiene care plan to prevent deterioration of oral health, which in turn, will help the targeted population maintain independence in completing daily activities and quality of life for an extended period of time.

Read the detailed description

Dyads that each consist of an individual with mild dementia and his/her care partner will be enrolled at two sites, Duke University in Durham, North Carolina and New York University in New York, New York. This is an unblinded, randomized trial to assess the acceptability and effectiveness of the oral health intervention among individuals with mild dementia (MD). The study will utilize qualitative and quantitative methods to learn about the oral health outcomes in individuals with mild dementia.

The study lasts 6 months. The first three months is the active intervention phase in which coaching and educational modules are delivered. The second three months is the maintenance period in which no coaching or educational modules are presented to participants. As a team, the study coordinator, the oral health evaluator (a dental hygienist), and the interventionist will conduct three visits with the participants and their care partners; baseline, 3-month (end of the active intervention phase), and 6-month (end of three-month maintenance phase).

The intervention protocol will include three groups; two treatment groups and one control group. All participants will receive oral health education material at the baseline visit. Treatment Group 1 and Treatment Group 2 will be given a smart electronic toothbrush. Only Treatment Group 2 will receive the in-home and telephone coaching throughout the duration of the study and will be instructed to record daily brushing habits. The coaching sessions include individualized instruction on oral hygiene technique, cueing strategy development, or oral hygiene monitoring and coaching. Treatment Group 1 and the Control Group will not receive the coaching sessions.

Conditions: Mild Dementia
Being tested: Care Partner-Assisted Intervention
Keywords: oral health, oral hygiene, dementia, care partner, periodontal disease
Medical subject headings: Dementia, Periodontal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Care Partner-Assisted InterventionBehavioural
Tailored teaching and coaching

Study groups in NCT04390750
Study group	Role	What they receive
Treatment Group 1	No intervention	Treatment Group 1 will receive a standard educational booklet, a clinical oral health evaluation and a smart electronic toothbrush with no instruction on oral hygiene technique. The study coordinator will download the toothbrush data for data collection. The dental hygienist will observe the participant's normal toothbrushing technique, interdental cleaning procedures and the cleaning of partial dentures. No instruction is provided. The hygienist will provide basic instruction on proper use of the smart electronic toothbrush.
Treatment Group 2	Experimental	Treatment Group 2 will receive a standard educational booklet, a smart electronic toothbrush, a clinical oral health evaluation with tailored instruction on oral hygiene technique and care partner coaching. The study coordinator will download the toothbrush data for data collection. The dental hygienist and interventionist will work together to fulfill the following intervention components: tailored instruction and coaching. Receives: Behavioral: Care Partner-Assisted Intervention
Control Group	No intervention	The Control group will receive a standard educational booklet and a clinical oral health evaluation with no instruction on oral hygiene technique. The dental hygienist will observe the participant's normal toothbrushing technique, interdental cleaning procedures and the cleaning of partial dentures. No instruction is provided.

What is being measured

The primary outcome is the main question the study is designed to answer.

Plaque Index
UNC Modified Green and Vermillion Oral Hygiene Index. Plaque was measured per tooth, 0 = No plaque, 1 = Plaque covers <1/3 tooth, 2 = Plaque covers >=1/3 but <2/3 tooth and 3 = Plaque covers >=2/3 tooth. The index values were calculated as the proportion of sites with plaque deposits on at least less than 1/3 of crown. The index value is the proportion of sites with plaque deposits. Higher index values indicate higher levels of plaque.
Measured: 3 months
Gingival Index
UNC Modified Loe and Silness Gingival Index Gingival inflammation is evaluated per tooth, classified as 0 = Normal gingiva, 1 = Mild inflammation, no bleeding on probing, 2 = Moderate inflammation, bleeding on probing, 3 = Severe inflammation, tendency to spontaneous bleeding. Index values were calculated as the proportion of sites with at least some mild inflammation. The index value is the proportion of sites with inflammation. Higher index values indicate greater gingival inflammation.
Measured: 3 months
Plaque Index
UNC Modified Green and Vermillion Oral Hygiene Index. Plaque was measured per tooth, 0 = No plaque, 1 = Plaque covers <1/3 tooth, 2 = Plaque covers >=1/3 but <2/3 tooth and 3 = Plaque covers >=2/3 tooth. The index values were calculated as the proportion of sites with plaque deposits on at least less than 1/3 of crown. The index value is the proportion of sites with plaque deposits. Higher index values indicate higher levels of plaque.
Measured: 6 months
Gingival Index
UNC Modified Loe and Silness Gingival Index Gingival inflammation is evaluated per tooth, classified as 0 = Normal gingiva, 1 = Mild inflammation, no bleeding on probing, 2 = Moderate inflammation, bleeding on probing, 3 = Severe inflammation, tendency to spontaneous bleeding. Index values were calculated as the proportion of sites with at least some mild inflammation. The index value is the proportion of sites with inflammation. Higher index values indicate greater gingival inflammation.
Measured: 6 months

Secondary outcomes (12)

Frequency of Toothbrushing
Participants' frequency toothbrushing Categorical variable with the following response types: 'Less than Twice a Day' or 'Twice a Day or more'.
Measured: 3 months
Frequency of Toothbrushing
Participants' frequency toothbrushing Categorical variable with the following response types: 'Less than Twice a Day' or 'Twice a Day or more'.
Measured: 6 months
Duration of Toothbrushing
Participants' duration of toothbrushing. Reported by the dental hygienist. Categorical variable consisting of 3 response types (< 1minute; > 1 minute \& < 2minute; > 2 minute per toothbrushing session).
Measured: 3 months
Duration of Toothbrushing
Participants' duration of toothbrushing. Reported by the dental hygienist. Categorical variable consisting of 3 response types (< 1minute; > 1 minute \& < 2minute; > 2 minute per toothbrushing session).
Measured: 6 months
Frequency of Interdental Cleaning
Participants' frequency of interdental cleaning Collected via self-report via care partner. Categorical variable ranging from 'Never' to 'Twice a Day or More'.
Measured: 3 months
Frequency of Interdental Cleaning
Participants' frequency of interdental cleaning. Collected via self-report via care partner. Categorical variable ranging from 'Never' to 'Twice a Day or More'.
Measured: 6 months
Interproximal Cleaning Technique
Participants' Interproximal Cleaning Technique Reported by the dental hygienist. Categorical variable, with the following response types: 'Less than Optimal' or 'Interproximal Surfaces Cleaned Using 'C' shape'.
Measured: 3 months
Interproximal Cleaning Technique
Participants' Interproximal Cleaning Technique. Reported by the dental hygienist. Categorical variable, with the following response types: 'Less than Optimal' or 'Interproximal Surfaces Cleaned Using 'C' shape'.
Measured: 6 months
Oral Health Hygiene Score
Participant Oral Hygiene Skills. Reported by the dental hygienist. Average score on the Oral Hygiene Assessment Sheet of Routine Care Questionnaire. Scores range from 1 to 3. Lower scores indicate higher oral health hygiene.
Measured: 3 months
Oral Health Hygiene Score
Participant Oral Hygiene Skills. Reported from dental hygienist. Average score on the Oral Hygiene Assessment Sheet of Routine Care Questionnaire. Scores on this scale range from 1 to 3. Lower scores indicate higher oral health hygiene.
Measured: 6 months
Oral Health Knowledge Score
Participant Oral Health Knowledge Score Scores were calculated as the proportion of correct responses on the Modified Oral Health Knowledge section of the Study Participant Questionnaire. Higher scores indicate greater oral health knowledge. Range is 0-1.
Measured: 3 months
Oral Health Knowledge Score
Participant Oral Health Knowledge Score Scores were calculated as the proportion of correct responses on the Modified Oral Health Knowledge section of the Study Participant Questionnaire. Higher scores indicate greater oral health knowledge. Range is 0-1.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Oct 202125 Mar 2024

First posted18 May 2020
Study start22 Oct 2021
Primary completion25 Mar 2024
Study completion25 Mar 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Mild DementiaStudies of the same condition, open and under way.
More trials run by New York UniversityThe sponsor's other registered studies.
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: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Model description: 3 Groups - 2 Treatment Groups, 1 Control Group
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04390750
Sponsor's protocol ID: 18-068-E
Other IDs: U01DE027512
Status last verified: Oct 2023
First submitted: 14 May 2020
Last updated: 9 Dec 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: The de-identified individual participant data collected during the trial will be shared between 9 months and 36 months following article publication or as required by a condition of awards and agreements supporting the research, for researchers who provide a methodologically sound proposal. Data will be made available at https://www.icpsr.umich.edu/web/pages (Note: a specific link will be provided after the study is published/when the DOI is obtained.) The protocol, statistical analysis plan, and analytic code will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Publications

Wu B, Plassman BL, Poole P, Siamdoust S, Bunn M, Burwell B, Pei Y, Downey C, Gomes D, Kamer A, Yu G, Leak Bryant A, Anderson RA. Study protocol for a randomised controlled trial of a care partner assisted intervention to improve oral health of individuals with mild dementia. BMJ Open. 2022 Jun 22;12(6):e057099. doi: 10.1136/bmjopen-2021-057099.
PubMed 35732396

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Community-based Screening for Alzheimer's Disease
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
RecruitingObservational study
InRAD Observational Study
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
Recruiting
Telehealth-Adapted Compensatory Training and Intervention for Cognition
MCI, Mild Cognitive Impairment
Not yet recruitingObservational study
Prospective Research on Identification of Dementia in Early Stages (P.R.I.D.E)
Mild Cognitive Impairment, Memory Disorders

All Mild Dementia trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Care Partner Assisted Intervention to Improve Oral Health of Individuals With Mild Dementia
ClinicalTrials.gov ID: NCT04390750
Acronym / sponsor ID: 18-068-E
Conditions: Mild Dementia
Keywords: oral health, oral hygiene, dementia, care partner, periodontal disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: New York UniversityUniversity, hospital or other
Collaborators: Duke University, University of North Carolina, Chapel Hill, NYU Langone Health, National Institute of Dental and Craniofacial Research (NIDCR)
Study start: 22 Oct 2021 (actual)
Primary completion: 25 Mar 2024 (actual)
Study completion: 25 Mar 2024 (actual)
First posted: 18 May 2020 (actual)
Results: Posted 28 Nov 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: 3 Groups - 2 Treatment Groups, 1 Control Group

Arm	Type	Receives
Treatment Group 1	No intervention	–Treatment Group 1 will receive a standard educational booklet, a clinical oral health evaluation and a smart electronic toothbrush with no instruction on oral hygiene technique. The study coordinator will download the toothbrush data for data collection. The dental hygienist will observe the participant's normal toothbrushing technique, interdental cleaning procedures and the cleaning of partial dentures. No instruction is provided. The hygienist will provide basic instruction on proper use of the smart electronic toothbrush.
Treatment Group 2	Experimental	Behavioral: Care Partner-Assisted InterventionTreatment Group 2 will receive a standard educational booklet, a smart electronic toothbrush, a clinical oral health evaluation with tailored instruction on oral hygiene technique and care partner coaching. The study coordinator will download the toothbrush data for data collection. The dental hygienist and interventionist will work together to fulfill the following intervention components: tailored instruction and coaching.
Control Group	No intervention	–The Control group will receive a standard educational booklet and a clinical oral health evaluation with no instruction on oral hygiene technique. The dental hygienist will observe the participant's normal toothbrushing technique, interdental cleaning procedures and the cleaning of partial dentures. No instruction is provided.

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

a diagnosis of mild dementia
have at least 4 natural teeth
60 years and older
living with an informal caregiver (i.e. care partner) who is age 18 or older and is willing to participate in the intervention
community-dwelling and physically able to brush own teeth

Key exclusion criteria (8 listed)

unable to have an oral health evaluation
prescribed antibiotics prior to a regular dental visit
has sensory or physical problems that prevent participation in the intervention
has a terminal illness or behavioral or psychiatric disorder that would interfere with participation in the intervention
has a medical condition such as serious congenital heart conditions, previous infective endocarditis, prosthetic cardiac valves, and cardiac transplantation with cardiac valvulopathy that places him/her at greater risk of infection from the manipulation of the gums to measure the gingival index

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
Care Partner-Assisted InterventionTailored teaching and coaching	Behavioural	Treatment Group 2

Primary outcome

Plaque Index
Time frame: 3 months
UNC Modified Green and Vermillion Oral Hygiene Index. Plaque was measured per tooth, 0 = No plaque, 1 = Plaque covers <1/3 tooth, 2 = Plaque covers >=1/3 but <2/3 tooth and 3 = Plaque covers >=2/3 tooth. The index values were calculated as the proportion of sites with plaque deposits on at least less than 1/3 of crown. The index value is the proportion of sites with plaque deposits. Higher index values indicate higher levels of plaque.
Gingival Index
Time frame: 3 months
UNC Modified Loe and Silness Gingival Index Gingival inflammation is evaluated per tooth, classified as 0 = Normal gingiva, 1 = Mild inflammation, no bleeding on probing, 2 = Moderate inflammation, bleeding on probing, 3 = Severe inflammation, tendency to spontaneous bleeding. Index values were calculated as the proportion of sites with at least some mild inflammation. The index value is the proportion of sites with inflammation. Higher index values indicate greater gingival inflammation.
Plaque Index
Time frame: 6 months
UNC Modified Green and Vermillion Oral Hygiene Index. Plaque was measured per tooth, 0 = No plaque, 1 = Plaque covers <1/3 tooth, 2 = Plaque covers >=1/3 but <2/3 tooth and 3 = Plaque covers >=2/3 tooth. The index values were calculated as the proportion of sites with plaque deposits on at least less than 1/3 of crown. The index value is the proportion of sites with plaque deposits. Higher index values indicate higher levels of plaque.
Gingival Index
Time frame: 6 months
UNC Modified Loe and Silness Gingival Index Gingival inflammation is evaluated per tooth, classified as 0 = Normal gingiva, 1 = Mild inflammation, no bleeding on probing, 2 = Moderate inflammation, bleeding on probing, 3 = Severe inflammation, tendency to spontaneous bleeding. Index values were calculated as the proportion of sites with at least some mild inflammation. The index value is the proportion of sites with inflammation. Higher index values indicate greater gingival inflammation.

12 secondary outcomes

Frequency of Toothbrushing
Time frame: 3 months
Frequency of Toothbrushing
Time frame: 6 months
Duration of Toothbrushing
Time frame: 3 months
Duration of Toothbrushing
Time frame: 6 months
Frequency of Interdental Cleaning
Time frame: 3 months
Frequency of Interdental Cleaning
Time frame: 6 months
Interproximal Cleaning Technique
Time frame: 3 months
Interproximal Cleaning Technique
Time frame: 6 months
Oral Health Hygiene Score
Time frame: 3 months
Oral Health Hygiene Score
Time frame: 6 months
Oral Health Knowledge Score
Time frame: 3 months
Oral Health Knowledge Score
Time frame: 6 months

Results and safety

Results posted to the registry on 28 Nov 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment Group 1	20	18
Treatment Group 2	20	17
Control Group	20	19

Primary outcome: Plaque Index

Time frame: 3 months. Mean (Standard Deviation). Unit: Proportion of sites with plaque deposits

Measure	Treatment Group 1 n = 18	Treatment Group 2 n = 17	Control Group n = 18
Value	0.55 (0.36)	0.41 (0.25)	0.48 (0.32)

Treatment Group 1 vs Control Group: Interaction coefficient: 0.00 (95% CI -0.11 to 0.11), p = 0.939, Linear mixed effects model
Treatment Group 2 vs Control Group: Interaction coefficient: -0.09 (95% CI -0.21 to 0.02), p = 0.103, Linear mixed effects model

Population analysed: 6 participants were withdrawn after the baseline visit, and 1 participant did not complete assessment at 3 months.

Primary outcome: Gingival Index

Time frame: 3 months. Mean (Standard Deviation). Unit: Proportion of sites with inflammation.

Measure	Treatment Group 1 n = 18	Treatment Group 2 n = 17	Control Group n = 18
Value	0.61 (0.39)	0.37 (0.39)	0.47 (0.42)

Treatment Group 1 vs Control Group: Interaction coefficient: 0.00 (95% CI -0.16 to 0.16), p = 0.995, Linear mixed effects model
Treatment Group 2 vs Control Group: Interaction coefficient: -0.12 (95% CI -0.28 to 0.04), p = 0.132, Linear mixed effects model

Population analysed: 6 participants were withdrawn after the baseline visit, and 1 participant did not complete assessment at 3 months.

Primary outcome: Plaque Index

Time frame: 6 months. Mean (Standard Deviation). Unit: Proportion of sites with plaque deposits

Measure	Treatment Group 1 n = 18	Treatment Group 2 n = 17	Control Group n = 19
Value	0.55 (0.35)	0.45 (0.28)	0.53 (0.30)

Treatment Group 1 vs Control Group: Interaction coefficient: -0.05 (95% CI -0.16 to 0.06), p = 0.402, Linear mixed effects model
Treatment Group 2 vs Control Group: Interaction coefficient: -0.10 (95% CI -0.21 to 0.01), p = 0.072, Linear mixed effects model

Population analysed: 6 participants were withdrawn after the baseline visit.

Primary outcome: Gingival Index

Time frame: 6 months. Mean (Standard Deviation). Unit: Proportion of sites with inflammation.

Measure	Treatment Group 1 n = 18	Treatment Group 2 n = 17	Control Group n = 19
Value	0.58 (0.39)	0.43 (0.35)	0.63 (0.41)

Treatment Group 1 vs Control Group: Interaction coefficient: -0.20 (95% CI -0.36 to -0.04), p = 0.014, Linear mixed effects model
Treatment Group 2 vs Control Group: Interaction coefficient: -0.23 (95% CI -0.39 to -0.07), p = 0.005, Linear mixed effects model.

Population analysed: 6 participants were withdrawn after the baseline visit.

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 6 months from Enrollment Date. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment Group 1	0 of 20 (0%)	1 of 20 (5%)	0 of 20
Treatment Group 2	0 of 20 (0%)	2 of 20 (10%)	0 of 20
Control Group	0 of 20 (0%)	0 of 20 (0%)	0 of 20

Limitations and caveats (from the sponsor): We were unable to meet target accrual which may have limited the ability to detect statistically significant differences across arms, primarily due to the following barriers: reduced frequency of patient visits to clinics during the COVID-19 pandemic, which limited in-person recruitment and establishing relationships with non-affiliated hospitals and organizations.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35732396Wu B, Plassman BL, Poole P, Siamdoust S, Bunn M, Burwell B, Pei Y, Downey C, Gomes D, Kamer A, Yu G, Leak Bryant A, Anderson RA. Study protocol for a randomised controlled trial of a care partner assisted intervention to improve oral health of individuals with mild dementia. BMJ Open. 2022 Jun 22;12(6):e057099. doi: 10.1136/bmjopen-2021-057099.
Individual participant dataSharing planned: Yes. The de-identified individual participant data collected during the trial will be shared between 9 months and 36 months following article publication or as required by a condition of awards and agreements supporting the research, for researchers who provide a methodologically sound proposal. Data will be made available at https://www.icpsr.umich.edu/web/pages (Note: a specific link will be provided after the study is published/when the DOI is obtained.) The protocol, statistical analysis plan, and analytic code will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Related trials for Mild Dementia

Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Community-based Screening for Alzheimer's Disease
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
RecruitingObservational study
InRAD Observational Study
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
Recruiting
Telehealth-Adapted Compensatory Training and Intervention for Cognition
MCI, Mild Cognitive Impairment
Not yet recruitingObservational study
Prospective Research on Identification of Dementia in Early Stages (P.R.I.D.E)
Mild Cognitive Impairment, Memory Disorders

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.

Bei Wu, PhD principal investigator

New York University

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Care Partner-Assisted Intervention in people with Mild Dementia, run by New York University at 2 sites in United States.

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 6 inclusion and 8 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 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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?

Yes. Results are posted in the registry (first posted 28 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Plaque Index (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04390750, which also lists 1 linked publication.

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 9 Dec 2025.