Mild Dementia
Conditions
Keywords
oral health, oral hygiene, dementia, care partner, periodontal disease
Brief summary
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.
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.
Interventions
BEHAVIORALCare Partner-Assisted Intervention
Tailored teaching and coaching
Sponsors
Duke University
University of North Carolina, Chapel Hill
NYU Langone Health
National Institute of Dental and Craniofacial Research (NIDCR)
New York University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
3 Groups - 2 Treatment Groups, 1 Control Group
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plaque Index | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Interdental Cleaning | 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'. |
| Interproximal Cleaning Technique | 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'. |
| Frequency of Toothbrushing | 3 months | Participants' frequency toothbrushing Categorical variable with the following response types: 'Less than Twice a Day' or 'Twice a Day or more'. |
| Oral Health Knowledge Score | 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. |
| Oral Health Hygiene Score | 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. |
| Duration of Toothbrushing | 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). |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| 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. | 20 |
| 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. | 20 |
| Total | 60 |
Baseline characteristics
| Characteristic | Treatment Group 1 | Treatment Group 2 | Control Group | Total |
|---|---|---|---|---|
| Age, Continuous | 75.05 Years STANDARD_DEVIATION 6.61 | 74.65 Years STANDARD_DEVIATION 6.43 | 76.35 Years STANDARD_DEVIATION 6.77 | 75.35 Years STANDARD_DEVIATION 6.53 |
| Duration of Toothbrushing >= 1 min & < 2 minutes | 8 Participants | 11 Participants | 7 Participants | 26 Participants |
| Duration of Toothbrushing < 1 minute | 7 Participants | 3 Participants | 6 Participants | 16 Participants |
| Duration of Toothbrushing >= 2 minutes | 5 Participants | 6 Participants | 7 Participants | 18 Participants |
| Frequency of interdental cleaning Hardly ever | 1 Participants | 3 Participants | 4 Participants | 8 Participants |
| Frequency of interdental cleaning Never | 4 Participants | 3 Participants | 2 Participants | 9 Participants |
| Frequency of interdental cleaning Once a day | 4 Participants | 4 Participants | 4 Participants | 12 Participants |
| Frequency of interdental cleaning Once or less than once a week | 1 Participants | 4 Participants | 2 Participants | 7 Participants |
| Frequency of interdental cleaning Several times a week | 2 Participants | 2 Participants | 3 Participants | 7 Participants |
| Frequency of interdental cleaning Twice a day or more | 7 Participants | 4 Participants | 5 Participants | 16 Participants |
| Frequency of interdental cleaning Unknown | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Frequency of Toothbrushing < Twice a day | 7 Participants | 8 Participants | 7 Participants | 22 Participants |
| Frequency of Toothbrushing >= Twice a day | 13 Participants | 12 Participants | 13 Participants | 38 Participants |
| Gingival Index | 0.68 Proportion of sites with inflammation STANDARD_DEVIATION 0.34 | 0.59 Proportion of sites with inflammation STANDARD_DEVIATION 0.38 | 0.52 Proportion of sites with inflammation STANDARD_DEVIATION 0.37 | 0.60 Proportion of sites with inflammation STANDARD_DEVIATION 0.36 |
| Interproximal cleaning technique Less than optimal | 18 Participants | 15 Participants | 12 Participants | 45 Participants |
| Interproximal cleaning technique Optimal | 2 Participants | 5 Participants | 8 Participants | 15 Participants |
| Oral health hygiene score | 2.18 Scores on a scale STANDARD_DEVIATION 0.41 | 1.88 Scores on a scale STANDARD_DEVIATION 0.43 | 1.82 Scores on a scale STANDARD_DEVIATION 0.53 | 1.96 Scores on a scale STANDARD_DEVIATION 0.46 |
| Oral health knowledge score | 0.66 Scores on a scale STANDARD_DEVIATION 0.19 | 0.65 Scores on a scale STANDARD_DEVIATION 0.18 | 0.68 Scores on a scale STANDARD_DEVIATION 0.15 | 0.66 Scores on a scale STANDARD_DEVIATION 0.18 |
| Plaque Index | 0.62 Proportion of sites with plaque deposits STANDARD_DEVIATION 0.32 | 0.60 Proportion of sites with plaque deposits STANDARD_DEVIATION 0.25 | 0.54 Proportion of sites with plaque deposits STANDARD_DEVIATION 0.32 | 0.59 Proportion of sites with plaque deposits STANDARD_DEVIATION 0.31 |
| Race/Ethnicity, Customized Race/ethnicity Hispanic | 2 Participants | 1 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized Race/ethnicity Non-Hispanic Black | 3 Participants | 4 Participants | 4 Participants | 11 Participants |
| Race/Ethnicity, Customized Race/ethnicity Non-Hispanic White | 15 Participants | 15 Participants | 15 Participants | 45 Participants |
| Sex: Female, Male Female | 9 Participants | 8 Participants | 10 Participants | 27 Participants |
| Sex: Female, Male Male | 11 Participants | 12 Participants | 10 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 1 / 20 | 2 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 | 0 / 20 |
Outcome results
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.
Time frame: 3 months
Population: 6 participants were withdrawn after the baseline visit, and 1 participant did not complete assessment at 3 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group 1 | Gingival Index | 0.61 Proportion of sites with inflammation. | Standard Deviation 0.39 |
| Treatment Group 2 | Gingival Index | 0.37 Proportion of sites with inflammation. | Standard Deviation 0.39 |
| Control Group | Gingival Index | 0.47 Proportion of sites with inflammation. | Standard Deviation 0.42 |
Comparison: 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.p-value: 0.99595% CI: [-0.16, 0.16]Linear mixed effects model
Comparison: 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.p-value: 0.13295% CI: [-0.28, 0.04]Linear mixed effects model
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.
Time frame: 6 months
Population: 6 participants were withdrawn after the baseline visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group 1 | Gingival Index | 0.58 Proportion of sites with inflammation. | Standard Deviation 0.39 |
| Treatment Group 2 | Gingival Index | 0.43 Proportion of sites with inflammation. | Standard Deviation 0.35 |
| Control Group | Gingival Index | 0.63 Proportion of sites with inflammation. | Standard Deviation 0.41 |
Comparison: 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.p-value: 0.01495% CI: [-0.36, -0.04]Linear mixed effects model
Comparison: 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.p-value: 0.00595% CI: [-0.39, -0.07]Linear mixed effects model.
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.
Time frame: 6 months
Population: 6 participants were withdrawn after the baseline visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group 1 | Plaque Index | 0.55 Proportion of sites with plaque deposits | Standard Deviation 0.35 |
| Treatment Group 2 | Plaque Index | 0.45 Proportion of sites with plaque deposits | Standard Deviation 0.28 |
| Control Group | Plaque Index | 0.53 Proportion of sites with plaque deposits | Standard Deviation 0.3 |
Comparison: 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.p-value: 0.40295% CI: [-0.16, 0.06]Linear mixed effects model
Comparison: 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.p-value: 0.07295% CI: [-0.21, 0.01]Linear mixed effects model
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.
Time frame: 3 months
Population: 6 participants were withdrawn after the baseline visit, and 1 participant did not complete assessment at 3 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group 1 | Plaque Index | 0.55 Proportion of sites with plaque deposits | Standard Deviation 0.36 |
| Treatment Group 2 | Plaque Index | 0.41 Proportion of sites with plaque deposits | Standard Deviation 0.25 |
| Control Group | Plaque Index | 0.48 Proportion of sites with plaque deposits | Standard Deviation 0.32 |
Comparison: 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 primary endpoint of 3 months.p-value: 0.93995% CI: [-0.11, 0.11]Linear mixed effects model
Comparison: 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 primary endpoint of 3 months.p-value: 0.10395% CI: [-0.21, 0.02]Linear mixed effects model
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).
Time frame: 3 months
Population: 6 participants were withdrawn after the baseline visit, and 1 participant did not complete assessment at 3 months.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment Group 1 | Duration of Toothbrushing | >= 2 min | 10 Participants |
| Treatment Group 1 | Duration of Toothbrushing | >= 1 min & < 2 min | 5 Participants |
| Treatment Group 1 | Duration of Toothbrushing | < 1min | 3 Participants |
| Treatment Group 1 | Duration of Toothbrushing | Unknown | 0 Participants |
| Treatment Group 2 | Duration of Toothbrushing | Unknown | 1 Participants |
| Treatment Group 2 | Duration of Toothbrushing | >= 2 min | 9 Participants |
| Treatment Group 2 | Duration of Toothbrushing | < 1min | 1 Participants |
| Treatment Group 2 | Duration of Toothbrushing | >= 1 min & < 2 min | 6 Participants |
| Control Group | Duration of Toothbrushing | Unknown | 0 Participants |
| Control Group | Duration of Toothbrushing | >= 1 min & < 2 min | 8 Participants |
| Control Group | Duration of Toothbrushing | < 1min | 6 Participants |
| Control Group | Duration of Toothbrushing | >= 2 min | 4 Participants |
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).
Time frame: 6 months
Population: 6 participants were withdrawn after the baseline visit.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment Group 1 | Duration of Toothbrushing | >= 2 min | 5 Participants |
| Treatment Group 1 | Duration of Toothbrushing | >= 1 min & < 2 min | 10 Participants |
| Treatment Group 1 | Duration of Toothbrushing | < 1min | 3 Participants |
| Treatment Group 1 | Duration of Toothbrushing | Unknown | 0 Participants |
| Treatment Group 2 | Duration of Toothbrushing | Unknown | 0 Participants |
| Treatment Group 2 | Duration of Toothbrushing | >= 2 min | 8 Participants |
| Treatment Group 2 | Duration of Toothbrushing | < 1min | 2 Participants |
| Treatment Group 2 | Duration of Toothbrushing | >= 1 min & < 2 min | 7 Participants |
| Control Group | Duration of Toothbrushing | Unknown | 0 Participants |
| Control Group | Duration of Toothbrushing | >= 1 min & < 2 min | 9 Participants |
| Control Group | Duration of Toothbrushing | < 1min | 4 Participants |
| Control Group | Duration of Toothbrushing | >= 2 min | 6 Participants |
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'.
Time frame: 3 months
Population: 6 participants were withdrawn after the baseline visit, and 1 participant did not complete assessment at 3 months.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment Group 1 | Frequency of Interdental Cleaning | Twice a day or more | 4 Participants |
| Treatment Group 1 | Frequency of Interdental Cleaning | Once a day | 6 Participants |
| Treatment Group 1 | Frequency of Interdental Cleaning | Several times a week | 3 Participants |
| Treatment Group 1 | Frequency of Interdental Cleaning | Once or less than once a week | 1 Participants |
| Treatment Group 1 | Frequency of Interdental Cleaning | Hardly ever | 0 Participants |
| Treatment Group 1 | Frequency of Interdental Cleaning | Never | 4 Participants |
| Treatment Group 2 | Frequency of Interdental Cleaning | Never | 1 Participants |
| Treatment Group 2 | Frequency of Interdental Cleaning | Twice a day or more | 4 Participants |
| Treatment Group 2 | Frequency of Interdental Cleaning | Once or less than once a week | 5 Participants |
| Treatment Group 2 | Frequency of Interdental Cleaning | Hardly ever | 1 Participants |
| Treatment Group 2 | Frequency of Interdental Cleaning | Once a day | 4 Participants |
| Treatment Group 2 | Frequency of Interdental Cleaning | Several times a week | 2 Participants |
| Control Group | Frequency of Interdental Cleaning | Once a day | 3 Participants |
| Control Group | Frequency of Interdental Cleaning | Several times a week | 3 Participants |
| Control Group | Frequency of Interdental Cleaning | Never | 2 Participants |
| Control Group | Frequency of Interdental Cleaning | Once or less than once a week | 4 Participants |
| Control Group | Frequency of Interdental Cleaning | Twice a day or more | 5 Participants |
| Control Group | Frequency of Interdental Cleaning | Hardly ever | 1 Participants |
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'.
Time frame: 6 months
Population: 6 participants were withdrawn after the baseline visit.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment Group 1 | Frequency of Interdental Cleaning | Twice a day or more | 4 Participants |
| Treatment Group 1 | Frequency of Interdental Cleaning | Once a day | 4 Participants |
| Treatment Group 1 | Frequency of Interdental Cleaning | Several times a week | 5 Participants |
| Treatment Group 1 | Frequency of Interdental Cleaning | Once or less than once a week | 0 Participants |
| Treatment Group 1 | Frequency of Interdental Cleaning | Hardly ever | 3 Participants |
| Treatment Group 1 | Frequency of Interdental Cleaning | Never | 2 Participants |
| Treatment Group 2 | Frequency of Interdental Cleaning | Never | 2 Participants |
| Treatment Group 2 | Frequency of Interdental Cleaning | Twice a day or more | 4 Participants |
| Treatment Group 2 | Frequency of Interdental Cleaning | Once or less than once a week | 3 Participants |
| Treatment Group 2 | Frequency of Interdental Cleaning | Hardly ever | 2 Participants |
| Treatment Group 2 | Frequency of Interdental Cleaning | Once a day | 4 Participants |
| Treatment Group 2 | Frequency of Interdental Cleaning | Several times a week | 2 Participants |
| Control Group | Frequency of Interdental Cleaning | Once a day | 7 Participants |
| Control Group | Frequency of Interdental Cleaning | Several times a week | 1 Participants |
| Control Group | Frequency of Interdental Cleaning | Never | 3 Participants |
| Control Group | Frequency of Interdental Cleaning | Once or less than once a week | 1 Participants |
| Control Group | Frequency of Interdental Cleaning | Twice a day or more | 5 Participants |
| Control Group | Frequency of Interdental Cleaning | Hardly ever | 2 Participants |
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'.
Time frame: 3 months
Population: 6 participants were withdrawn after the baseline visit, and 1 participant did not complete assessment at 3 months.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment Group 1 | Frequency of Toothbrushing | < Twice a week | 2 Participants |
| Treatment Group 1 | Frequency of Toothbrushing | >= Twice a week | 16 Participants |
| Treatment Group 2 | Frequency of Toothbrushing | < Twice a week | 4 Participants |
| Treatment Group 2 | Frequency of Toothbrushing | >= Twice a week | 13 Participants |
| Control Group | Frequency of Toothbrushing | < Twice a week | 6 Participants |
| Control Group | Frequency of Toothbrushing | >= Twice a week | 12 Participants |
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'.
Time frame: 6 months
Population: 6 participants were withdrawn after the baseline visit.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment Group 1 | Frequency of Toothbrushing | < Twice a week | 3 Participants |
| Treatment Group 1 | Frequency of Toothbrushing | >= Twice a week | 15 Participants |
| Treatment Group 2 | Frequency of Toothbrushing | < Twice a week | 4 Participants |
| Treatment Group 2 | Frequency of Toothbrushing | >= Twice a week | 13 Participants |
| Control Group | Frequency of Toothbrushing | < Twice a week | 4 Participants |
| Control Group | Frequency of Toothbrushing | >= Twice a week | 15 Participants |
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'.
Time frame: 3 months
Population: 6 participants were withdrawn after the baseline visit, and 1 participant did not complete assessment at 3 months.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment Group 1 | Interproximal Cleaning Technique | Less than optimal | 14 Participants |
| Treatment Group 1 | Interproximal Cleaning Technique | Optimal | 4 Participants |
| Treatment Group 2 | Interproximal Cleaning Technique | Less than optimal | 11 Participants |
| Treatment Group 2 | Interproximal Cleaning Technique | Optimal | 6 Participants |
| Control Group | Interproximal Cleaning Technique | Less than optimal | 10 Participants |
| Control Group | Interproximal Cleaning Technique | Optimal | 8 Participants |
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'.
Time frame: 6 months
Population: 6 participants were withdrawn after the baseline visit.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment Group 1 | Interproximal Cleaning Technique | Less than optimal | 13 Participants |
| Treatment Group 1 | Interproximal Cleaning Technique | Optimal | 5 Participants |
| Treatment Group 2 | Interproximal Cleaning Technique | Less than optimal | 9 Participants |
| Treatment Group 2 | Interproximal Cleaning Technique | Optimal | 8 Participants |
| Control Group | Interproximal Cleaning Technique | Less than optimal | 11 Participants |
| Control Group | Interproximal Cleaning Technique | Optimal | 8 Participants |
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.
Time frame: 3 months
Population: 6 participants were withdrawn after the baseline visit, and 1 participant did not complete assessment at 3 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group 1 | Oral Health Hygiene Score | 1.83 Scores on a scale | Standard Deviation 0.67 |
| Treatment Group 2 | Oral Health Hygiene Score | 1.64 Scores on a scale | Standard Deviation 0.44 |
| Control Group | Oral Health Hygiene Score | 1.78 Scores on a scale | Standard Deviation 0.45 |
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.
Time frame: 6 months
Population: 6 participants were withdrawn after the baseline visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group 1 | Oral Health Hygiene Score | 1.85 Scores on a scale | Standard Deviation 0.53 |
| Treatment Group 2 | Oral Health Hygiene Score | 1.58 Scores on a scale | Standard Deviation 0.46 |
| Control Group | Oral Health Hygiene Score | 1.85 Scores on a scale | Standard Deviation 0.43 |
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.
Time frame: 3 months
Population: 6 participants were withdrawn after the baseline visit, and 1 participant did not complete assessment at 3 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group 1 | Oral Health Knowledge Score | 0.71 Scores on a scale | Standard Deviation 0.2 |
| Treatment Group 2 | Oral Health Knowledge Score | 0.81 Scores on a scale | Standard Deviation 0.12 |
| Control Group | Oral Health Knowledge Score | 0.73 Scores on a scale | Standard Deviation 0.17 |
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.
Time frame: 6 months
Population: 6 participants were withdrawn after the baseline visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group 1 | Oral Health Knowledge Score | 0.65 Scores on a scale | Standard Deviation 0.24 |
| Treatment Group 2 | Oral Health Knowledge Score | 0.76 Scores on a scale | Standard Deviation 0.19 |
| Control Group | Oral Health Knowledge Score | 0.68 Scores on a scale | Standard Deviation 0.15 |