N/A N=60 Randomized Supportive Care

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

Mild Dementia

Bottom Line

View on ClinicalTrials.gov: NCT04390750 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2025

Primary outcome: Primary: Plaque Index — 0.55; 0.41; 0.48 Proportion of sites with plaque deposits — p=0.939

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Care Partner-Assisted Intervention (Behavioral)
Age: Adult, Older Adult · 60+ yrs
Sex: All
Sponsor: New York University
Primary completion: Mar 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Plaque Index	0.55; 0.45; 0.53	0.402
PRIMARY Gingival Index	0.58; 0.43; 0.63	0.014 sig
PRIMARY Plaque Index	0.55; 0.45; 0.53	0.402
PRIMARY Gingival Index	0.58; 0.43; 0.63	0.014 sig
SECONDARY Frequency of Toothbrushing	3; 4; 4; 15; 13; 15	—
SECONDARY Frequency of Toothbrushing	3; 4; 4; 15; 13; 15	—
SECONDARY Duration of Toothbrushing	5; 8; 6; 10; 7; 9	—
SECONDARY Duration of Toothbrushing	5; 8; 6; 10; 7; 9	—
SECONDARY Frequency of Interdental Cleaning	4; 4; 5; 4; 4; 7	—
SECONDARY Frequency of Interdental Cleaning	4; 4; 5; 4; 4; 7	—
SECONDARY Interproximal Cleaning Technique	13; 9; 11; 5; 8; 8	—
SECONDARY Interproximal Cleaning Technique	13; 9; 11; 5; 8; 8	—
SECONDARY Oral Health Hygiene Score	1.85; 1.58; 1.85	—
SECONDARY Oral Health Hygiene Score	1.85; 1.58; 1.85	—
SECONDARY Oral Health Knowledge Score	0.65; 0.76; 0.68	—
SECONDARY Oral Health Knowledge Score	0.65; 0.76; 0.68	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04390750). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.