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Behavioural Intervention
Toothbrush for Oral Hygiene
N/A
Waitlist Available
Led By Adam Lowenstein, MS, DMD
Research Sponsored by Center for Disability Services, New York
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights
Study Summary
This trial evaluates the safety of a manual toothbrush for caregivers to use to help clean the teeth of people with disabilities, assessing device failure and Adverse Device Effects (ADEs) over 28 days. Up to 12 subjects will be enrolled.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events related to toothbrush use.
Incidence of device failure.
Secondary outcome measures
Perception of cleanliness following use of the experimental toothbrush based on a Likert scale.
Trial Design
1Treatment groups
Experimental Treatment
Group I: ToothbrushExperimental Treatment1 Intervention
Use of experimental toothbrush for 28 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enable Oral Hygiene System (EOHS)
2023
N/A
~20
Find a Location
Who is running the clinical trial?
Center for Disability Services, New YorkLead Sponsor
1 Previous Clinical Trials
130 Total Patients Enrolled
Tufts University School of Dental MedicineOTHER
6 Previous Clinical Trials
580 Total Patients Enrolled
Adam Lowenstein, MS, DMDPrincipal InvestigatorTufts University School of Dental Medicine
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