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Daily Mouth Care for Aging Residents

N/A

Recruiting

Led By Sheryl Zimmerman, PhD

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Are 18 years of age or older

Assisted living staff

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 8 months

Awards & highlights

Study Summary

This trial will help to reduce pneumonia among assisted living residents with dementia by providing daily mouth care and reducing bacteria in the mouth that can lead to aspiration pneumonia.

Who is the study for?

This trial is for staff in assisted living facilities who are at least 18 years old and fluent in English. They will be trained to provide daily mouth care aimed at reducing pneumonia risk among residents with dementia.Check my eligibility

What is being tested?

The intervention being tested is a program of daily mouth care for assisted living residents with dementia, taught to caregivers by dental hygienists, aiming to lower the incidence of aspiration pneumonia.See study design

What are the potential side effects?

There may not be direct side effects from the intervention as it involves oral hygiene practices; however, discomfort or resistance from some residents during mouth care could occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Select...

I live with assistance from staff.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 8 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 8 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 8 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

Change in Denture Plaque Index Score (DPI) over time

Change in Gingival Index Score for Long-Term Care (GI-LTC) over time

Change in Plaque Index Score for Long-Term Care (PI-LTC) over time

Secondary outcome measures

Interventional procedure

Average number of days mouth care was performed

Dental hygienists self-efficacy to train nursing assistants

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Daily Mouth CareExperimental Treatment1 Intervention

The intervention being tested is a standardized educational and skill-building program for use in assisted living communities, which highlights that mouth care is infection control (e.g., can reduce pneumonia); includes techniques and products to clean and protect the teeth, tongue, gums, and dentures (e.g., the jiggle-sweep approach to remove plaque, use of an interdental brush instead of floss); provides strategies for care provision in special situations (e.g., broken teeth); and includes a toolkit of dementia-sensitive approaches for people who are resistant (e.g., refuse to open the mouth). It also includes information about potential dental emergencies and issues that merit assessment.

Group II: Standard Mouth CareActive Control1 Intervention

Assisted living communities will continue to provide standard mouth care to all residents. Assisted living staff will not receive training or supplies in the control condition.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Daily Mouth Care

2013

N/A

~1420

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor

1,504 Previous Clinical Trials

4,185,882 Total Patients Enrolled

1 Trials studying Long Term Care

1,764 Patients Enrolled for Long Term Care

National Institute on Aging (NIA)NIH

1,669 Previous Clinical Trials

28,003,334 Total Patients Enrolled

1 Trials studying Long Term Care

1,764 Patients Enrolled for Long Term Care

Sheryl Zimmerman, PhDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill

3 Previous Clinical Trials

3,570 Total Patients Enrolled

1 Trials studying Long Term Care

1,764 Patients Enrolled for Long Term Care

Media Library

Long Term Care Clinical Trial 2023: Daily Mouth Care Highlights & Side Effects. Trial Name: NCT03892200 — N/A

Frequently Asked Questions

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

What is the intention of this experiment?

"As the primary outcome, researchers will track changes in Denture Plaque Index Score (DPI) over a period of roughly 8 months. As secondary objectives, they are measuring Staff Self-Efficacy to provide mouth care using a 35 category questionnaire that is ranked from 1 (strongly disagree) to 4 (strongly agree). Additionally, Texas Christian University Workshop Evaluation and Intervention Appropriateness Measure scores will be calculated for all participants at baseline and 8 month intervals respectively."

Answered by AI

What is the magnitude of participation in this clinical trial?

"Accurately, clinicaltrials.gov highlights that the recruitment for this medical study is ongoing. It first appeared on October 1st 2019 and was last revised on May 24th 2022, with a total of 1780 patients being sought from one location."

Answered by AI

Is this clinical experiment currently recruiting participants?

"Evident from the listings on clinicaltrials.gov, this trial is currently recruiting participants as of May 24th 2022. Initially posted October 1st 2019, it has been updated regularly ever since."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Oral Hygiene in Assisted Living

2019. "Oral Hygiene in Assisted Living". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03892200.