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Clinical Trials/NCT06397079
NCT06397079
Completed
Not Applicable

Investigation of Effect on Oral Care Program for Residents in Long-term Care Facility

National Taipei University of Nursing and Health Sciences1 site in 1 country30 target enrollmentSeptember 16, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Elder
Sponsor
National Taipei University of Nursing and Health Sciences
Enrollment
30
Locations
1
Primary Endpoint
Tongue Coating Index
Status
Completed
Last Updated
3 months ago

Overview

Brief Summary

The aim of this study is to investigate the effectiveness of an oral care program on the oral hygiene for residents in long-term care facility.

Detailed Description

The study adopts a randomized clinical trial design and utilizes a cross-over design. The main outcomes include assessments of oral health (Oral Health Assessment Tool, Oral Health Impact Profile, Geriatric Oral Health Assessment Index), tongue coating cleanliness (Tongue Coating Index), dental plaque and gum cleanliness (Plaque Index, Gingival Index, Gingival Bleeding Index), and swallowing ability (Eating Assessment Tool, Function Oral Intake Scale, International Dysphagia Diet Standardisation Initiative).

Registry
clinicaltrials.gov
Start Date
September 16, 2024
End Date
December 16, 2024
Last Updated
3 months ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

En-Chi Chiu

Associate Professor

National Taipei University of Nursing and Health Sciences

Eligibility Criteria

Inclusion Criteria

  • Eating by mouth
  • Able to express fluently in Chinese after correcting vision and hearing
  • Normal hand functions
  • Able to follow instructions
  • Willing to participate in the study and sign the informed consent

Exclusion Criteria

  • Unconsicous
  • Diagnosis of dementia and inability to communicate
  • Having a tracheostomy tube and nasogastric tube
  • Unable to move both upper limbs
  • Vulnerable populations (e.g., political, economic, or socially disadvantaged groups)

Outcomes

Primary Outcomes

Tongue Coating Index

Time Frame: Baseline to 4 weeks

The Tongue Coating Index assesses tongue cleanliness. The score ranges is 0 to 18. A higher core indicates lower cleanliness of the tongue.

Gingival Index

Time Frame: Baseline to 4 weeks

The Gingival Index assesses gingival health. The score ranges is 0 to 3. A higher score indicates poorer gingival health.

Function Oral lntake Scale

Time Frame: Baseline to 4 weeks

The Functional Oral Intake Scale assesses swallowing ability. The score ranges is 1 to 7. A higher score indicates greater swallowing ability.

Oral Health Impact Profile

Time Frame: Baseline to 4 weeks

The Oral Health Impact Profile assesses the quality of oral health-related life. The score ranges is 0 to 56. A higher score indicates poorer oral health-related quality of life.

Geriatric Oral Health Assessment Index

Time Frame: Baseline to 4 weeks

The Geriatric Oral Health Assessment Index evaluates oral health for older people. The score ranges is 12 to 60. A higher score indicates better oral health.

Plaque Index

Time Frame: Baseline to 4 weeks

Plaque Index assesses amount of dental plaque. The score ranges is 0 to 3. A higher score indicates lower amount of dental plaque.

Oral Health Assessment Tool

Time Frame: Baseline to 4 weeks

The Oral Health Assessment Tool is a scale for evaluating oral health. The score ranges is 0 to 16. A higher score indicates a poorer oral health condition.

Eating Assessment Tool

Time Frame: Baseline to 4 weeks

The Eating Assessment Tool evaluates the degree of swallowing status. The score ranges is 0 to 40. A higher score indicates lower swallowing ability.

International Dysphagia Diet Standardisation Initiative

Time Frame: Baseline to 4 weeks

The International Dysphagia Diet Standardisation Initiative assesses swallowing ability. The score ranges is 0 to 7. A higher score indicates greater swallowing ability.

Gingival Bleeding Index

Time Frame: Baseline to 4 weeks

The Gingival Bleeding Index assesses gingival health. The score ranges is 0 to 1. A higher score indicates poorer gingival health.

Study Sites (1)

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