Oral Care Program for Residients in Long-term Care Facility

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Oral Hygiene; Elder
• Intervention / Treatment: Behavioral: Electric toothbrush; Behavioral: Soft bristle toothbrush

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).

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: En-Chi Chiu, PhD; Phone Number: 1291 +886-2-28227101; Email: enchichiu@ntunhs.edu.tw

Study Locations

• Taiwan
  • Xindian Dist
    • New Taipei City, Xindian Dist, Taiwan, 231403
      • Cardinal Tien Hospital
      • Contact: En-Chi Chiu, PhD; Phone Number: 1291 +886-2-28227101; Email: enchichiu@ntunhs.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Eating by mouth
2. Able to express fluently in Chinese after correcting vision and hearing
3. Normal hand functions
4. Able to follow instructions
5. Willing to participate in the study and sign the informed consent

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Electric toothbrush; Teach Bass brushing technique and use electric toothbrush	Behavioral: Electric toothbrush; Teach Bass brushing technique and bursh teeth using electric toothbrush dental hygiene three times a day.
Active Comparator: Soft bristle toothbrush; Teach Bass brushing technique and use soft bristle toothbrush	Behavioral: Soft bristle toothbrush; Teach Bass brushing technique and bursh teeth using soft bristle toothbrush dental hygiene three times a day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral Health Impact Profile	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.	Baseline to 4 weeks
Oral Health Assessment Tool	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.	Baseline to 4 weeks
Geriatric Oral Health Assessment Index	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.	Baseline to 4 weeks
Tongue Coating Index	The Tongue Coating Index assesses tongue cleanliness. The score ranges is 0 to 18. A higher core indicates lower cleanliness of the tongue.	Baseline to 4 weeks
Plaque Index	Plaque Index assesses amount of dental plaque. The score ranges is 0 to 3. A higher score indicates lower amount of dental plaque.	Baseline to 4 weeks
Gingival Index	The Gingival Index assesses gingival health. The score ranges is 0 to 3. A higher score indicates poorer gingival health.	Baseline to 4 weeks
Gingival Bleeding Index	The Gingival Bleeding Index assesses gingival health. The score ranges is 0 to 1. A higher score indicates poorer gingival health.	Baseline to 4 weeks
Eating Assessment Tool	The Eating Assessment Tool evaluates the degree of swallowing status. The score ranges is 0 to 40. A higher score indicates lower swallowing ability.	Baseline to 4 weeks
Function Oral lntake Scale	The Functional Oral Intake Scale assesses swallowing ability. The score ranges is 1 to 7. A higher score indicates greater swallowing ability.	Baseline to 4 weeks
International Dysphagia Diet Standardisation Initiative	The International Dysphagia Diet Standardisation Initiative assesses swallowing ability. The score ranges is 0 to 7. A higher score indicates greater swallowing ability.	Baseline to 4 weeks

Collaborators and Investigators

• Sponsor: National Taipei University of Nursing and Health Sciences
• Investigators: Study Director: En-Chi Chiu, PhD, National Taipei University of Nursing and Health Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): May 10, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: April 29, 2024
• First Submitted That Met QC Criteria: April 29, 2024
• First Posted (Actual): May 2, 2024

Study Record Updates

• Last Update Posted (Actual): May 6, 2024
• Last Update Submitted That Met QC Criteria: May 2, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: oral hygiene; long-term care facility; elder
• Other Study ID Numbers: CTH-113-3-5-004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No