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Oral health promotion strategy for Oral Hygiene (OHPROM Trial)

N/A
Waitlist Available
Research Sponsored by University of Louisville
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 12 months
Awards & highlights

OHPROM Trial Summary

This trial will test whether the OHPROM intervention can reduce psychiatric symptoms and improve functioning for people with IDD.

Eligible Conditions
  • Oral Hygiene

OHPROM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The of this study is change in the oral health status of persons with IDD at 4 months and 12 months in comparison to the control group, after controlling for oral health status at baseline as measured by the Community Periodontal Index.
The of this study is the change in the oral health status of persons with IDD at 4 months and 12 months in comparison to the control group, after controlling for oral health status at baseline as measured by the Modified Gingival Index.
Secondary outcome measures
Change in Oral hygiene practices of persons with IDD will be measured by a dental oral examination guided by the Simplified Oral Hygiene Index (OHI-S) from baseline to 4 months and 12 months in the experimental group compared to the control group.
Change in caregiver behavioral capability from baseline to 4 months and 12 months in the experimental group compared to the control group of caregivers.
Change in caregiver outcome expectancies from baseline to 4 months and 12 months in the experimental group compared to the control group of caregivers.
+3 more

OHPROM Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
Homes where participants with intellectual/developmental disabilities reside will be randomly assigned to the intervention arm. Caregivers working in that home will receive the oral health promotion strategy/intervention over the course of a year.
Group II: ControlActive Control1 Intervention
Homes where participants with intellectual/developmental disabilities reside will be randomly assigned to the control arm. Caregivers in that home will not receive the oral health promotion strategy/intervention over the course of a year but will be offered a compressed intervention after a year.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oral health promotion strategy
2018
N/A
~420

Find a Location

Who is running the clinical trial?

University of LouisvilleLead Sponsor
338 Previous Clinical Trials
75,568 Total Patients Enrolled
National Institute of Dental and Craniofacial Research (NIDCR)NIH
300 Previous Clinical Trials
847,932 Total Patients Enrolled
2 Trials studying Oral Hygiene
1,265 Patients Enrolled for Oral Hygiene

Frequently Asked Questions

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

Are there still volunteer opportunities available for those wishing to partake in this experiment?

"The details on clinicaltrials.gov indicate that this trial, which was first posted in June 2018 and last updated in June 2022, is not presently looking for individuals to enroll. Nevertheless, 40 alternative studies are actively recruiting patients now."

Answered by AI

Does this research project accept applicants over the age of 25?

"This specific trial is restricted to those aged between 18 and 75. However, there are 28 trials that accept minors and 15 studies open to seniors."

Answered by AI

What are the research objectives of this investigation?

"This 12-month study seeks to evaluate the impacts of a specific intervention on oral health outcomes in individuals with intellectual and developmental disabilities (IDD). The primary measure for success is the changes observed in Modified Gingival Index scores between baseline, 4 months, and 12 months. Secondary objectives are gauging caregiver self-efficacy using an adapted version of the General Self-Efficacy Scale as well as quantifying environmental influences and Oral hygiene practices through specific assessments such as Simplified Oral Hygiene Index."

Answered by AI

Who is likely to gain the most benefit from involvement in this research project?

"This research endeavour is asking for 500 volunteers aged 18 to 75 who possess oral health, and meet other specific requirements. Those hoping to participate must be direct care staff members at a group/family home; willing and able to follow the protocol of this trial until its conclusion; residents in one of six partner organisations associated with these homes; and diagnosed with mild, moderate, severe or profound intellectual or developmental disability."

Answered by AI
~60 spots leftby Apr 2025