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临床试验/NCT07401693
NCT07401693
已完成
不适用

The Effect of Oral Health Care Program on Oral Hygiene and Oral Function for the Elderly Patient With Dementia in Day Care Center

Shiou-fang Lu1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2023年7月20日最近更新:

概览

阶段
不适用
状态
已完成
发起方
Shiou-fang Lu
入组人数
64
试验地点
1
主要终点
Oral hygiene

概览

简要总结

This study evaluated the effects of an oral health care program on oral hygiene and oral function in older adults with dementia attending a day care center. Participants received a structured oral health care intervention, and changes in oral hygiene and oral function were assessed over a 4-week follow-up period. The goal of this study was to explore whether a structured oral health care program could help improve oral health outcomes in older adults with dementia in a day care setting.

详细描述

This study employed a quasi-experimental design to examine the effects of an oral health care program on oral hygiene and oral function among older adults with dementia attending a day care center. Participants received a structured oral health care intervention designed to promote oral hygiene practices and oral functional ability. Outcome measures related to oral hygiene and oral function were assessed at baseline and at 4 weeks after the intervention. This study aimed to provide evidence on the effectiveness of an oral health care program for improving oral health outcomes in older adults with dementia in a day care setting.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

Outcome assessors were blinded to group assignment

入排标准

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

入选标准

  • Adults aged 60 years or older.
  • Diagnosed with dementia by a physician.
  • Attending a day care center.
  • Able to participate in the oral health care program and assessments.
  • Provided informed consent from the participant or a legally authorized representative

排除标准

  • Presence of acute medical conditions that would interfere with participation.
  • Severe physical or mental conditions that prevent completion of the intervention or outcome assessments.
  • Refusal or inability to provide informed consent.

研究组 & 干预措施

Oral Health Care Program

Experimental

Participants assigned to the intervention group received a structured oral health care program designed to improve oral hygiene and oral function. Outcome measures were assessed at baseline and at 4 weeks after the intervention.

干预措施: Oral Health Care Program (Behavioral)

Usual Care (Waiting-list Control)

No Intervention

Participants assigned to the control (waiting-list) group did not receive the oral health care intervention during the study period and continued with usual care. Outcome measures were assessed at baseline and at 4 weeks.

结局指标

主要结局

Oral hygiene

时间窗: From baseline to 4 weeks after intervention

Oral hygiene was assessed using the Oral Health Assessment Tool (OHAT) as the primary outcome measure. OHAT is a validated composite scale with a total score ranging from 0 to 16, with higher total scores indicating poorer oral health status.

Oral function

时间窗: From baseline to 4 weeks after intervention

Oral function was assessed using standardized functional assessments to evaluate changes in oral motor and swallowing function following the oral care intervention. Higher scores or values indicate better oral or swallowing function.

次要结局

  • Plaque index(From baseline to 4 weeks after intervention)
  • Tongue coating index(From baseline to 4 weeks after intervention.)
  • Puff cheeks(From baseline to 4 weeks after intervention.)
  • Choke(From baseline to 4 weeks after intervention.)
  • Repetitive Saliva Swallowing Test (RSST)(From baseline to 4 weeks after intervention.)
  • Oral DDK rate(times/10')(From baseline to 4 weeks after intervention.)

研究者

发起方
Shiou-fang Lu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Shiou-fang Lu

Assistant Professor

Tzu Chi University

研究点 (1)

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