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| ID | Type | Description | Link |
|---|---|---|---|
| U01DE027512 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Duke University | OTHER |
| University of North Carolina, Chapel Hill | OTHER |
| NYU Langone Health | OTHER |
| National Institute of Dental and Craniofacial Research (NIDCR) |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Care Partner-Assisted Intervention | Behavioral | Tailored teaching and coaching |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Toothbrushing | Participants' frequency toothbrushing Categorical variable with the following response types: 'Less than Twice a Day' or 'Twice a Day or more'. | 3 months |
| Frequency of Toothbrushing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bei Wu, PhD | New York University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York City (Participants Homes) | New York | New York | 10010 | United States | ||
| North Carolina (Participants Homes) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35732396 | Derived | 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. |
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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.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Data will be made available at Clinicaltrials.gov and ICPSR (a specific link will be provided after the study is published/when the DOI is obtained).
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 6 participants were withdrawn after the baseline visit, and 1 participant did not complete assessment at 3 months. | Posted | Mean | Standard Deviation | Proportion of sites with plaque deposits | 3 months |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gum Soreness | Skin and subcutaneous tissue disorders | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bei Wu | New York University | 12129925951 | bw75@nyu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 25, 2024 | Aug 21, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003704 | Dementia |
| D010510 | Periodontal Diseases |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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| NIH |
3 Groups - 2 Treatment Groups, 1 Control Group
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| 6 months |
Participants' frequency toothbrushing Categorical variable with the following response types: 'Less than Twice a Day' or 'Twice a Day or more'.
| 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). | 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). | 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'. | 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'. | 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'. | 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'. | 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. | 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. | 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. | 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. | 6 months |
| Durham |
| North Carolina |
| 27708 |
| United States |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Plaque Index | UNC Modified Green and Vermillion Oral Hygiene Index. The index value is the proportion of sites with plaque deposits. | Mean | Standard Deviation | Proportion of sites with plaque deposits |
|
| Gingival Index | UNC Modified Loe and Silness Gingival Index. The index value is the proportion of sites with inflammation. | Mean | Standard Deviation | Proportion of sites with inflammation |
|
| Frequency of Toothbrushing | Count of Participants | Participants |
|
| Duration of Toothbrushing | Count of Participants | Participants |
|
| Frequency of interdental cleaning | Count of Participants | Participants |
|
| Interproximal cleaning technique | Count of Participants | Participants |
|
| Oral health knowledge score | Mean | Standard Deviation | Scores on a scale |
|
| Oral health hygiene score | Mean | Standard Deviation | Scores on a scale |
|
| OG001 | 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. |
| OG002 | 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. |
|
|
|
| Primary | 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. | 6 participants were withdrawn after the baseline visit, and 1 participant did not complete assessment at 3 months. | Posted | Mean | Standard Deviation | Proportion of sites with inflammation. | 3 months |
|
|
|
|
| Primary | 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. | 6 participants were withdrawn after the baseline visit. | Posted | Mean | Standard Deviation | Proportion of sites with plaque deposits | 6 months |
|
|
|
|
| Primary | 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. | 6 participants were withdrawn after the baseline visit. | Posted | Mean | Standard Deviation | Proportion of sites with inflammation. | 6 months |
|
|
|
|
| Secondary | Frequency of Toothbrushing | Participants' frequency toothbrushing Categorical variable with the following response types: 'Less than Twice a Day' or 'Twice a Day or more'. | 6 participants were withdrawn after the baseline visit, and 1 participant did not complete assessment at 3 months. | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Secondary | Frequency of Toothbrushing | Participants' frequency toothbrushing Categorical variable with the following response types: 'Less than Twice a Day' or 'Twice a Day or more'. | 6 participants were withdrawn after the baseline visit. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | 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). | 6 participants were withdrawn after the baseline visit, and 1 participant did not complete assessment at 3 months. | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Secondary | 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). | 6 participants were withdrawn after the baseline visit. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | 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'. | 6 participants were withdrawn after the baseline visit, and 1 participant did not complete assessment at 3 months. | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Secondary | 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'. | 6 participants were withdrawn after the baseline visit. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | 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'. | 6 participants were withdrawn after the baseline visit, and 1 participant did not complete assessment at 3 months. | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Secondary | 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'. | 6 participants were withdrawn after the baseline visit. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | 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. | 6 participants were withdrawn after the baseline visit, and 1 participant did not complete assessment at 3 months. | Posted | Mean | Standard Deviation | Scores on a scale | 3 months |
|
|
|
| Secondary | 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. | 6 participants were withdrawn after the baseline visit. | Posted | Mean | Standard Deviation | Scores on a scale | 6 months |
|
|
|
| Secondary | 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. | 6 participants were withdrawn after the baseline visit, and 1 participant did not complete assessment at 3 months. | Posted | Mean | Standard Deviation | Scores on a scale | 3 months |
|
|
|
| Secondary | 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. | 6 participants were withdrawn after the baseline visit. | Posted | Mean | Standard Deviation | Scores on a scale | 6 months |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 1 |
| 20 |
| EG001 | 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. | 0 | 20 | 0 | 20 | 2 | 20 |
| EG002 | 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. | 0 | 20 | 0 | 20 | 0 | 20 |
| Tissue Trauma | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
Not provided
Not provided
| D001523 | Mental Disorders |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| A linear mixed effects model including an arm-by-time interaction was used to estimate between-arm differences in change in gingival inflammation at the primary endpoint of 3 months. | Linear mixed effects model | Linear mixed effects model with arm-by-time interaction. | 0.132 | Interaction coefficient | -0.12 | 95 | -0.28 | 0.04 | Other | The effect estimate reflects the adjusted difference in change from baseline on gingival inflammation between Treatment Group 2 and Control at 3 months. |
| A linear mixed effects model including an arm-by-time interaction was used to estimate between-arm differences in change in plaque levels at the secondary endpoint of 6 months. | Linear mixed effects model | Linear mixed effects model with arm-by-time interaction. | 0.072 | Interaction coefficient | -0.10 | 2-Sided | 95 | -0.21 | 0.01 | Other | The effect estimate reflects the adjusted difference in change from baseline on plaque levels between Treatment Group 2 and Control at 6 months. |
| A linear mixed effects model including an arm-by-time interaction was used to estimate between-arm differences in change in gingival inflammation at the secondary endpoint of 6 months. | Linear mixed effects model. | Linear mixed effects model with arm-by-time interaction. | 0.005 | Interaction coefficient | -0.23 | 2-Sided | 95 | -0.39 | -0.07 | Other | The effect estimate reflects the adjusted difference in change from baseline on gingival inflammation between Treatment Group 2 and Control at 6 months. |
| < 1min |
|
| Unknown |
|
| < 1min |
|
| Unknown |
|
| Several times a week |
|
| Once or less than once a week |
|
| Hardly ever |
|
| Never |
|
| Several times a week |
|
| Once or less than once a week |
|
| Hardly ever |
|
| Never |
|