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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 weeks
Treatment ~ Varies
Follow Up ~28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment open to individuals aged 20 and above in this medical research?

"This research project is open to adults aged 18 years or older, with the upper age limit set at 65."

Answered by AI

Is eligibility for this research study open to me?

"This clinical trial has a stringent acceptance criterion, demanding that applicants have good oral hygiene and be within the age brackets of 18-65. At this time, approximately 12 participants are being admitted to the study."

Answered by AI

What is the limit of participants in this research project?

"Affirmative. The information on clinicaltrials.gov demonstrates that this research is presently enrolling subjects. This investigation was initially posted on March 27th 2023 and recently revised on May 8th 2023, with the objective of recruiting 12 patients from a single site."

Answered by AI

Is enrollment available to volunteers at this time for the research?

"Affirmative. Clinicaltrials.gov displays that this clinical investigation, which was initially advertised on March 27th 2023, is actively seeking participants. 12 individuals need to be recruited from 1 medical centre for the trial to move forward."

Answered by AI

Who else is applying?

What state do they live in?
Massachusetts
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Caregiver Assisted Oral Hygiene for Individuals With Disabilities: Initial Safety
2023. "Caregiver Assisted Oral Hygiene for Individuals With Disabilities: Initial Safety". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05852886.
~6 spots leftby Apr 2025
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