Trial Outcomes & Findings for Care Partner Assisted Intervention to Improve Oral Health of Individuals With Mild Dementia (NCT NCT04390750)

Last Updated: 2025-12-09

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

60 participants

Primary outcome timeframe

3 months

Results posted on

2025-12-09

Participant Flow

Participants were recruited through the NYU ADRC, Duke Memory Disorders Clinic, and Montefiore CEAD. At NYU and CEAD, potential participants were identified from upcoming appointments, informed about the study by staff, and screened by phone. CEAD collaborators also partnered with community organizations to reach diverse populations. At Duke, participants were identified via electronic medical records, sent a letter, and contacted by a coordinator for phone screening.

Participant milestones

Participant milestones
Measure	Treatment Group 1 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 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.	Control Group 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.
Overall Study STARTED	20	20	20
Overall Study COMPLETED	18	17	19
Overall Study NOT COMPLETED	2	3	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Group 1 n=20 Participants 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 n=20 Participants 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.	Control Group n=20 Participants 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.	Total n=60 Participants Total of all reporting groups
Frequency of Toothbrushing >= Twice a day	13 Participants n=4 Participants	12 Participants n=50 Participants	13 Participants n=518 Participants	38 Participants n=175 Participants
Age, Continuous	75.05 Years STANDARD_DEVIATION 6.61 • n=4 Participants	74.65 Years STANDARD_DEVIATION 6.43 • n=50 Participants	76.35 Years STANDARD_DEVIATION 6.77 • n=518 Participants	75.35 Years STANDARD_DEVIATION 6.53 • n=175 Participants
Sex: Female, Male Female	9 Participants n=4 Participants	8 Participants n=50 Participants	10 Participants n=518 Participants	27 Participants n=175 Participants
Sex: Female, Male Male	11 Participants n=4 Participants	12 Participants n=50 Participants	10 Participants n=518 Participants	33 Participants n=175 Participants
Race/Ethnicity, Customized Race/ethnicity · Hispanic	2 Participants n=4 Participants	1 Participants n=50 Participants	1 Participants n=518 Participants	4 Participants n=175 Participants
Race/Ethnicity, Customized Race/ethnicity · Non-Hispanic Black	3 Participants n=4 Participants	4 Participants n=50 Participants	4 Participants n=518 Participants	11 Participants n=175 Participants
Race/Ethnicity, Customized Race/ethnicity · Non-Hispanic White	15 Participants n=4 Participants	15 Participants n=50 Participants	15 Participants n=518 Participants	45 Participants n=175 Participants
Plaque Index	0.62 Proportion of sites with plaque deposits STANDARD_DEVIATION 0.32 • n=4 Participants	0.60 Proportion of sites with plaque deposits STANDARD_DEVIATION 0.25 • n=50 Participants	0.54 Proportion of sites with plaque deposits STANDARD_DEVIATION 0.32 • n=518 Participants	0.59 Proportion of sites with plaque deposits STANDARD_DEVIATION 0.31 • n=175 Participants
Gingival Index	0.68 Proportion of sites with inflammation STANDARD_DEVIATION 0.34 • n=4 Participants	0.59 Proportion of sites with inflammation STANDARD_DEVIATION 0.38 • n=50 Participants	0.52 Proportion of sites with inflammation STANDARD_DEVIATION 0.37 • n=518 Participants	0.60 Proportion of sites with inflammation STANDARD_DEVIATION 0.36 • n=175 Participants
Frequency of Toothbrushing < Twice a day	7 Participants n=4 Participants	8 Participants n=50 Participants	7 Participants n=518 Participants	22 Participants n=175 Participants
Duration of Toothbrushing >= 2 minutes	5 Participants n=4 Participants	6 Participants n=50 Participants	7 Participants n=518 Participants	18 Participants n=175 Participants
Duration of Toothbrushing >= 1 min & < 2 minutes	8 Participants n=4 Participants	11 Participants n=50 Participants	7 Participants n=518 Participants	26 Participants n=175 Participants
Duration of Toothbrushing < 1 minute	7 Participants n=4 Participants	3 Participants n=50 Participants	6 Participants n=518 Participants	16 Participants n=175 Participants
Frequency of interdental cleaning Twice a day or more	7 Participants n=4 Participants	4 Participants n=50 Participants	5 Participants n=518 Participants	16 Participants n=175 Participants
Frequency of interdental cleaning Once a day	4 Participants n=4 Participants	4 Participants n=50 Participants	4 Participants n=518 Participants	12 Participants n=175 Participants
Frequency of interdental cleaning Several times a week	2 Participants n=4 Participants	2 Participants n=50 Participants	3 Participants n=518 Participants	7 Participants n=175 Participants
Frequency of interdental cleaning Once or less than once a week	1 Participants n=4 Participants	4 Participants n=50 Participants	2 Participants n=518 Participants	7 Participants n=175 Participants
Frequency of interdental cleaning Hardly ever	1 Participants n=4 Participants	3 Participants n=50 Participants	4 Participants n=518 Participants	8 Participants n=175 Participants
Frequency of interdental cleaning Never	4 Participants n=4 Participants	3 Participants n=50 Participants	2 Participants n=518 Participants	9 Participants n=175 Participants
Frequency of interdental cleaning Unknown	1 Participants n=4 Participants	0 Participants n=50 Participants	0 Participants n=518 Participants	1 Participants n=175 Participants
Interproximal cleaning technique Less than optimal	18 Participants n=4 Participants	15 Participants n=50 Participants	12 Participants n=518 Participants	45 Participants n=175 Participants
Interproximal cleaning technique Optimal	2 Participants n=4 Participants	5 Participants n=50 Participants	8 Participants n=518 Participants	15 Participants n=175 Participants
Oral health knowledge score	0.66 Scores on a scale STANDARD_DEVIATION 0.19 • n=4 Participants	0.65 Scores on a scale STANDARD_DEVIATION 0.18 • n=50 Participants	0.68 Scores on a scale STANDARD_DEVIATION 0.15 • n=518 Participants	0.66 Scores on a scale STANDARD_DEVIATION 0.18 • n=175 Participants
Oral health hygiene score	2.18 Scores on a scale STANDARD_DEVIATION 0.41 • n=4 Participants	1.88 Scores on a scale STANDARD_DEVIATION 0.43 • n=50 Participants	1.82 Scores on a scale STANDARD_DEVIATION 0.53 • n=518 Participants	1.96 Scores on a scale STANDARD_DEVIATION 0.46 • n=175 Participants

PRIMARY outcome

Timeframe: 3 months

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

Outcome measures

Outcome measures
Measure	Treatment Group 1 n=18 Participants 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 n=17 Participants 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.	Control Group n=18 Participants 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.
Plaque Index	0.55 Proportion of sites with plaque deposits Standard Deviation 0.36	0.41 Proportion of sites with plaque deposits Standard Deviation 0.25	0.48 Proportion of sites with plaque deposits Standard Deviation 0.32

PRIMARY outcome

Timeframe: 3 months

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

Outcome measures

Outcome measures
Measure	Treatment Group 1 n=18 Participants 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 n=17 Participants 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.	Control Group n=18 Participants 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.
Gingival Index	0.61 Proportion of sites with inflammation. Standard Deviation 0.39	0.37 Proportion of sites with inflammation. Standard Deviation 0.39	0.47 Proportion of sites with inflammation. Standard Deviation 0.42

PRIMARY outcome

Timeframe: 6 months

Population: 6 participants were withdrawn after the baseline visit.

Outcome measures

Outcome measures
Measure	Treatment Group 1 n=18 Participants 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 n=17 Participants 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.	Control Group n=19 Participants 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.
Plaque Index	0.55 Proportion of sites with plaque deposits Standard Deviation 0.35	0.45 Proportion of sites with plaque deposits Standard Deviation 0.28	0.53 Proportion of sites with plaque deposits Standard Deviation 0.30

PRIMARY outcome

Timeframe: 6 months

Population: 6 participants were withdrawn after the baseline visit.

Outcome measures

Outcome measures
Measure	Treatment Group 1 n=18 Participants 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 n=17 Participants 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.	Control Group n=19 Participants 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.
Gingival Index	0.58 Proportion of sites with inflammation. Standard Deviation 0.39	0.43 Proportion of sites with inflammation. Standard Deviation 0.35	0.63 Proportion of sites with inflammation. Standard Deviation 0.41

SECONDARY outcome

Timeframe: 3 months

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

Participants' frequency toothbrushing Categorical variable with the following response types: 'Less than Twice a Day' or 'Twice a Day or more'.

Outcome measures

Outcome measures
Measure	Treatment Group 1 n=18 Participants 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 n=17 Participants 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.	Control Group n=18 Participants 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.
Frequency of Toothbrushing >= Twice a week	16 Participants	13 Participants	12 Participants
Frequency of Toothbrushing < Twice a week	2 Participants	4 Participants	6 Participants

SECONDARY outcome

Timeframe: 6 months

Population: 6 participants were withdrawn after the baseline visit.

Participants' frequency toothbrushing Categorical variable with the following response types: 'Less than Twice a Day' or 'Twice a Day or more'.

Outcome measures

Outcome measures
Measure	Treatment Group 1 n=18 Participants 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 n=17 Participants 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.	Control Group n=19 Participants 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.
Frequency of Toothbrushing >= Twice a week	15 Participants	13 Participants	15 Participants
Frequency of Toothbrushing < Twice a week	3 Participants	4 Participants	4 Participants

SECONDARY outcome

Timeframe: 3 months

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

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).

Outcome measures

Outcome measures
Measure	Treatment Group 1 n=18 Participants 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 n=17 Participants 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.	Control Group n=18 Participants 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.
Duration of Toothbrushing >= 2 min	10 Participants	9 Participants	4 Participants
Duration of Toothbrushing >= 1 min & < 2 min	5 Participants	6 Participants	8 Participants
Duration of Toothbrushing < 1min	3 Participants	1 Participants	6 Participants
Duration of Toothbrushing Unknown	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 6 months

Population: 6 participants were withdrawn after the baseline visit.

Outcome measures

Outcome measures
Measure	Treatment Group 1 n=18 Participants 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 n=17 Participants 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.	Control Group n=19 Participants 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.
Duration of Toothbrushing >= 2 min	5 Participants	8 Participants	6 Participants
Duration of Toothbrushing >= 1 min & < 2 min	10 Participants	7 Participants	9 Participants
Duration of Toothbrushing < 1min	3 Participants	2 Participants	4 Participants
Duration of Toothbrushing Unknown	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 3 months

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

Participants' frequency of interdental cleaning Collected via self-report via care partner. Categorical variable ranging from 'Never' to 'Twice a Day or More'.

Outcome measures

Outcome measures
Measure	Treatment Group 1 n=18 Participants 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 n=17 Participants 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.	Control Group n=18 Participants 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.
Frequency of Interdental Cleaning Twice a day or more	4 Participants	4 Participants	5 Participants
Frequency of Interdental Cleaning Once a day	6 Participants	4 Participants	3 Participants
Frequency of Interdental Cleaning Several times a week	3 Participants	2 Participants	3 Participants
Frequency of Interdental Cleaning Once or less than once a week	1 Participants	5 Participants	4 Participants
Frequency of Interdental Cleaning Hardly ever	0 Participants	1 Participants	1 Participants
Frequency of Interdental Cleaning Never	4 Participants	1 Participants	2 Participants

SECONDARY outcome

Timeframe: 6 months

Population: 6 participants were withdrawn after the baseline visit.

Participants' frequency of interdental cleaning. Collected via self-report via care partner. Categorical variable ranging from 'Never' to 'Twice a Day or More'.

Outcome measures

Outcome measures
Measure	Treatment Group 1 n=18 Participants 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 n=17 Participants 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.	Control Group n=19 Participants 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.
Frequency of Interdental Cleaning Twice a day or more	4 Participants	4 Participants	5 Participants
Frequency of Interdental Cleaning Once a day	4 Participants	4 Participants	7 Participants
Frequency of Interdental Cleaning Several times a week	5 Participants	2 Participants	1 Participants
Frequency of Interdental Cleaning Once or less than once a week	0 Participants	3 Participants	1 Participants
Frequency of Interdental Cleaning Hardly ever	3 Participants	2 Participants	2 Participants
Frequency of Interdental Cleaning Never	2 Participants	2 Participants	3 Participants

SECONDARY outcome

Timeframe: 3 months

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

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'.

Outcome measures

Outcome measures
Measure	Treatment Group 1 n=18 Participants 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 n=17 Participants 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.	Control Group n=18 Participants 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.
Interproximal Cleaning Technique Less than optimal	14 Participants	11 Participants	10 Participants
Interproximal Cleaning Technique Optimal	4 Participants	6 Participants	8 Participants

SECONDARY outcome

Timeframe: 6 months

Population: 6 participants were withdrawn after the baseline visit.

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'.

Outcome measures

Outcome measures
Measure	Treatment Group 1 n=18 Participants 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 n=17 Participants 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.	Control Group n=19 Participants 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.
Interproximal Cleaning Technique Less than optimal	13 Participants	9 Participants	11 Participants
Interproximal Cleaning Technique Optimal	5 Participants	8 Participants	8 Participants

SECONDARY outcome

Timeframe: 3 months

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

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.

Outcome measures

Outcome measures
Measure	Treatment Group 1 n=18 Participants 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 n=17 Participants 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.	Control Group n=18 Participants 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.
Oral Health Hygiene Score	1.83 Scores on a scale Standard Deviation 0.67	1.64 Scores on a scale Standard Deviation 0.44	1.78 Scores on a scale Standard Deviation 0.45

SECONDARY outcome

Timeframe: 6 months

Population: 6 participants were withdrawn after the baseline visit.

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.

Outcome measures

Outcome measures
Measure	Treatment Group 1 n=18 Participants 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 n=17 Participants 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.	Control Group n=19 Participants 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.
Oral Health Hygiene Score	1.85 Scores on a scale Standard Deviation 0.53	1.58 Scores on a scale Standard Deviation 0.46	1.85 Scores on a scale Standard Deviation 0.43

SECONDARY outcome

Timeframe: 3 months

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

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.

Outcome measures

Outcome measures
Measure	Treatment Group 1 n=18 Participants 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 n=17 Participants 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.	Control Group n=18 Participants 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.
Oral Health Knowledge Score	0.71 Scores on a scale Standard Deviation 0.20	0.81 Scores on a scale Standard Deviation 0.12	0.73 Scores on a scale Standard Deviation 0.17

SECONDARY outcome

Timeframe: 6 months

Population: 6 participants were withdrawn after the baseline visit.

Outcome measures

Outcome measures
Measure	Treatment Group 1 n=18 Participants 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 n=17 Participants 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.	Control Group n=19 Participants 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.
Oral Health Knowledge Score	0.65 Scores on a scale Standard Deviation 0.24	0.76 Scores on a scale Standard Deviation 0.19	0.68 Scores on a scale Standard Deviation 0.15

Adverse Events

Treatment Group 1

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Treatment Group 2

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment Group 1 n=20 participants at risk 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 n=20 participants at risk 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.	Control Group n=20 participants at risk 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.
Skin and subcutaneous tissue disorders Tissue Trauma	5.0% 1/20 • Number of events 1 • Up to 6 months from Enrollment Date Subjects were monitored for adverse events over a 6-month period, beginning at enrollment and continuing through the last study visit.	0.00% 0/20 • Up to 6 months from Enrollment Date Subjects were monitored for adverse events over a 6-month period, beginning at enrollment and continuing through the last study visit.	0.00% 0/20 • Up to 6 months from Enrollment Date Subjects were monitored for adverse events over a 6-month period, beginning at enrollment and continuing through the last study visit.
Skin and subcutaneous tissue disorders Gum Soreness	0.00% 0/20 • Up to 6 months from Enrollment Date Subjects were monitored for adverse events over a 6-month period, beginning at enrollment and continuing through the last study visit.	10.0% 2/20 • Number of events 2 • Up to 6 months from Enrollment Date Subjects were monitored for adverse events over a 6-month period, beginning at enrollment and continuing through the last study visit.	0.00% 0/20 • Up to 6 months from Enrollment Date Subjects were monitored for adverse events over a 6-month period, beginning at enrollment and continuing through the last study visit.

Additional Information

Bei Wu

New York University

Phone: 12129925951

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place