Oral Care Program for Residients in Long-term Care Facility

Oral Hygiene Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06397079
• Other study ID #: CTH-113-3-5-004
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 10, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: National Taipei University of Nursing and Health Sciences
• Contact: En-Chi Chiu, PhD
• Phone: +886-2-28227101
• Email: enchichiu[@]ntunhs.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Oral Hygiene

Intervention

Behavioral:
• Electric toothbrush
Teach Bass brushing technique and bursh teeth using electric toothbrush dental hygiene three times a day.
• Soft bristle toothbrush
Teach Bass brushing technique and bursh teeth using soft bristle toothbrush dental hygiene three times a day.

Locations

Country	Name	City	State
Taiwan	Cardinal Tien Hospital	New Taipei City	Xindian Dist

Sponsors (1)

Lead Sponsor	Collaborator
National Taipei University of Nursing and Health Sciences

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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