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Care Partner-Assisted Oral Health Intervention for Dementia
N/A
Waitlist Available
Led By Bei Wu, PhD
Research Sponsored by New York University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of mild dementia
60 years and older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial is testing whether an intervention that includes a tailored oral care plan and a behavioral component can improve oral hygiene clinical outcomes for people with mild dementia.
Who is the study for?
This trial is for individuals aged 60 and older with mild dementia, who can brush their own teeth, have at least four natural teeth, and live with a care partner willing to participate. They must be able to follow simple commands and not have any conditions that would risk infection or interfere with the intervention.Check my eligibility
What is being tested?
The study tests a Care Partner-Assisted Intervention in New York City and North Carolina aimed at improving oral health in those with mild dementia. It includes a tailored oral care plan plus training using the Adaptive Leadership Framework to enhance daily oral hygiene practices.See study design
What are the potential side effects?
Since this trial focuses on non-invasive behavioral interventions for oral health, there are no direct medical side effects like you'd expect from medication. However, participants may experience discomfort or resistance to changes in their routine.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with mild dementia.
Select...
I am 60 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Gingival Index
Plaque Index
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Treatment Group 2Experimental Treatment1 Intervention
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.
Group II: Treatment Group 1Active Control1 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.
Group III: Control GroupActive Control1 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Care Partner-Assisted Intervention
2021
N/A
~70
Find a Location
Who is running the clinical trial?
National Institutes of Health (NIH)NIH
2,714 Previous Clinical Trials
7,511,271 Total Patients Enrolled
University of North Carolina, Chapel HillOTHER
1,513 Previous Clinical Trials
4,194,118 Total Patients Enrolled
Duke UniversityOTHER
2,375 Previous Clinical Trials
3,426,861 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My immune system is weakened due to a medical condition.I have a bleeding disorder or am on medication that increases my risk of bleeding.I have a heart condition that increases my risk of infection from dental procedures.You have been diagnosed with dementia by a specialist in the past year, and your recent cognitive assessment scores show mild dementia. You can follow simple instructions.I take antibiotics before dental visits.I am 60 years old or older.I have physical or sensory issues that stop me from joining the study.You live in a community, not in a hospital or care facility.I have been diagnosed with mild dementia.I have at least 4 natural teeth.You cannot have a dental check-up.I live with a caregiver who is 18 or older and willing to join the study with me.I can brush my teeth by myself.I had a joint replacement and it got infected.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Group 1
- Group 2: Treatment Group 2
- Group 3: Control Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the enrollment of test participants still open for this experiment?
"As per the details on clinicaltrials.gov, this trial is currently open for enrollment with an initial posting date of October 22nd 2021 and most recent update occurring April 1st 2022."
Answered by AI
To what extent is the scope of this research endeavor?
"Affirmative. Clinicaltrials.gov reveals that this clinical investigation is still enrolling patients - the trial was first published on October 22nd 2021 and has seen its most recent update on April 1st 2022. The investigators are looking for 120 participants to be recruited from 2 medical centres."
Answered by AI
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