Oral Health Intervention Pilot Study for Individuals With Memory Problems

NCT01808235 | Completed

• 1 other identifier: Pro00039035
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to pilot test an intervention to improve oral health for individuals with memory problems. The results from this study will assist in developing prevention and intervention programs aimed at maintaining good oral health, or at least slowing its deterioration.

Conditions

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• Change in oral health

  A licensed dental hygienist will perform an oral health examination at the beginning, mid-point, and end of the intervention, to assess any changes in the subject's teeth and gums.

  Day 1, 3 months, and 6 months

Secondary Outcomes (1)

• Changes in subjects' self-efficacy

  Day 1, 3 months, and 6 months

Other Outcomes (1)

• Changes in oral hygiene recorded using a brief questionnaire

  Every two weeks for six months

Study Arms (1)

Oral health intervention

EXPERIMENTAL

The dental hygienist will assess the IMD's tooth brushing technique and will provide specific feedback on the tooth brushing technique, including areas of the dentition missed in brushing. The IMDs will be given a powered toothbrush that records time, date and duration of toothbrushing activity, along with the direction and extent of motion of the toothbrushing activity. In addition, use of interdental cleaning aids will be recommended. The dental hygienist will review the findings from the oral health evaluation with the IMDs and caregivers, and provide detailed feedback on treatment and prevention of the oral health conditions and symptoms. The dental hygienist or study coordinator will call subjects by telephone biweekly to monitor oral hygiene practices and to provide coaching, if needed. Oral hygiene technique assessments will be conducted again three months after the first visit, and once more three months later, at the end of the intervention.

Behavioral: Oral Health Intervention

Interventions

Oral Health Intervention BEHAVIORAL

The dental hygienist will assess the IMD's tooth brushing technique and will provide specific feedback on the tooth brushing technique, including areas of the dentition missed in brushing. The IMDs will be given a powered toothbrush that records time, date and duration of toothbrushing activity, along with the direction and extent of motion of the toothbrushing activity. In addition, use of interdental cleaning aids will be recommended. The dental hygienist will review the findings from the oral health evaluation with the IMDs and caregivers, and provide detailed feedback on treatment and prevention of the oral health conditions and symptoms. The dental hygienist or study coordinator will call subjects by telephone biweekly to monitor oral hygiene practices and to provide coaching, if needed. Oral hygiene technique assessments will be conducted again three months after the first visit, and once more three months later, at the end of the intervention.

Oral health intervention

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A diagnosis of mild dementia within the past year.
• Have at least four natural teeth.
• years and older.
• Living with an informal caregiver who is willing to participate.
• Community-dwelling
• Physically able to brush own teeth.

You may not qualify if:

• Edentulism
• Unable to have an oral health evaluation done.
• Sensory or physical problems that prevent participation in the intervention.
• Terminal illness or hospitalization for a psychiatric disorder in the prior year.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Bei Wu, Ph.D.

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2013
• First Posted: March 11, 2013
• Study Start: July 1, 2012
• Primary Completion: February 3, 2017
• Study Completion: February 3, 2017
• Last Updated: March 30, 2017

Record last verified: 2017-03

Locations

US (1)