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临床试验/NCT06397079
NCT06397079已完成不适用

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

National Taipei University of Nursing and Health Sciences1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年9月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Tongue Coating Index

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

结局指标

主要结局

Tongue Coating Index

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

En-Chi Chiu

Associate Professor

National Taipei University of Nursing and Health Sciences

研究点 (1)

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