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Completed

NCT Number: NCT04390750

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

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.

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Key information

Conditions

Mild Dementia Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Mouth Diseases Nervous System Diseases Neurocognitive Disorders Periodontal Diseases Stomatognathic Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York City (Participants Homes), New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Care Partner-Assisted Intervention

Behavioral

Tailored teaching and coaching

Primary outcomes

  1. Plaque Index

    Time frame: 3 months

    UNC Modified Green and Vermillion Oral Hygiene Index. Plaque was measured per tooth, 0 = No plaque, 1 = Plaque covers <1/3 tooth, 2 = Plaque covers >=1/3 but <2/3 tooth and 3 = Plaque covers >=2/3 tooth. The index values were calculated as the proportion of sites with plaque deposits on at least less than 1/3 of crown. The index value is the proportion of sites with plaque deposits. Higher index values indicate higher levels of plaque.

  2. Gingival Index

    Time frame: 3 months

    UNC Modified Loe and Silness Gingival Index Gingival inflammation is evaluated per tooth, classified as 0 = Normal gingiva, 1 = Mild inflammation, no bleeding on probing, 2 = Moderate inflammation, bleeding on probing, 3 = Severe inflammation, tendency to spontaneous bleeding. Index values were calculated as the proportion of sites with at least some mild inflammation. The index value is the proportion of sites with inflammation. Higher index values indicate greater gingival inflammation.

  3. Plaque Index

    Time frame: 6 months

    UNC Modified Green and Vermillion Oral Hygiene Index. Plaque was measured per tooth, 0 = No plaque, 1 = Plaque covers <1/3 tooth, 2 = Plaque covers >=1/3 but <2/3 tooth and 3 = Plaque covers >=2/3 tooth. The index values were calculated as the proportion of sites with plaque deposits on at least less than 1/3 of crown. The index value is the proportion of sites with plaque deposits. Higher index values indicate higher levels of plaque.

  4. Gingival Index

    Time frame: 6 months

    UNC Modified Loe and Silness Gingival Index Gingival inflammation is evaluated per tooth, classified as 0 = Normal gingiva, 1 = Mild inflammation, no bleeding on probing, 2 = Moderate inflammation, bleeding on probing, 3 = Severe inflammation, tendency to spontaneous bleeding. Index values were calculated as the proportion of sites with at least some mild inflammation. The index value is the proportion of sites with inflammation. Higher index values indicate greater gingival inflammation.

Secondary outcomes

  1. Frequency of Toothbrushing

    Time frame: 3 months

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

  2. Frequency of Toothbrushing

    Time frame: 6 months

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

  3. Duration of Toothbrushing

    Time frame: 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).

  4. Duration of Toothbrushing

    Time frame: 6 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).

  5. Frequency of Interdental Cleaning

    Time frame: 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'.

  6. Frequency of Interdental Cleaning

    Time frame: 6 months

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

  7. Interproximal Cleaning Technique

    Time frame: 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'.

  8. Interproximal Cleaning Technique

    Time frame: 6 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'.

  9. Oral Health Hygiene Score

    Time frame: 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.

  10. Oral Health Hygiene Score

    Time frame: 6 months

    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.

  11. Oral Health Knowledge Score

    Time frame: 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.

  12. Oral Health Knowledge Score

    Time frame: 6 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.

Sponsors and collaborators

Lead sponsor

New York University

Other

Collaborators

  • Duke University
  • NYU Langone Health
  • National Institute of Dental and Craniofacial Research (NIDCR)
  • University of North Carolina, Chapel Hill

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
May 18, 2020
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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