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

NCT04390750 | Completed Results DMC

• 2 other identifiers: 18-068-EU01DE027512
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Mild Dementia

Keywords

oral health; oral hygiene; dementia; care partner; periodontal disease

Outcome Measures

Primary Outcomes (4)

• 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.

  6 months

Secondary Outcomes (12)

• Frequency of Toothbrushing

  3 months

• Frequency of Toothbrushing

  6 months

• Duration of Toothbrushing

  3 months

• Duration of Toothbrushing

  6 months

• Frequency of Interdental Cleaning

  3 months

Study Arms (3)

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.

Behavioral: Care Partner-Assisted Intervention

Control Group

NO INTERVENTION

The Control group will receive a standard educational booklet and a clinical oral health evaluation with no instruction on oral hygiene technique. The dental hygienist will observe the participant's normal toothbrushing technique, interdental cleaning procedures and the cleaning of partial dentures. No instruction is provided.

Interventions

Care Partner-Assisted Intervention BEHAVIORAL

Tailored teaching and coaching

Treatment Group 2

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a diagnosis of mild dementia
• have at least 4 natural teeth
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (2)

New York City (Participants Homes)

New York, New York, 10010, United States

Location

North Carolina (Participants Homes)

Durham, North Carolina, 27708, United States

Location

Related Publications (1)

• 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.

  PMID: 35732396 DERIVED

MeSH Terms

Conditions

Dementia; Periodontal Diseases

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Mouth Diseases; Stomatognathic Diseases

Limitations and Caveats

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.

Results Point of Contact

• Title: Bei Wu
• Organization: New York University

bw75@nyu.edu

12129925951

Study Officials

• Bei Wu, PhD

  New York University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 3 Groups - 2 Treatment Groups, 1 Control Group

Study Record Dates

• First Submitted: May 14, 2020
• First Posted: May 18, 2020
• Study Start: October 22, 2021
• Primary Completion: March 25, 2024
• Study Completion: March 25, 2024
• Last Updated: December 9, 2025
• Results First Posted: November 28, 2025

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: 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).

Locations

US (2)