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临床试验/NCT01639183
NCT01639183已完成不适用

The Effects of Daily Power Toothbrushing on Caregiver Compliance and on Oral and Systemic Inflammation in a Nursing Home Population: A Randomized Controlled Trial

University of Manitoba2 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2012年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
58
试验地点
2
主要终点
Oral Inflammation

研究概览

简要总结

The purpose of this study is to investigate whether brushing the teeth of nursing home residents with a power toothbrush as compared with standard care typically provided in nursing homes, will increase caregiver compliance with the provision of daily oral care as well as lower oral and systemic inflammation.

详细描述

It is well recognized worldwide that residents of nursing homes have poor oral health primarily due to caregiver resistance in the provision of daily oral hygiene care. Fear of being bitten or assaulted by the resident as well as lack of time and discomfort with working in the mouth, are reasons cited for this resistance. It is also now recognized that inflammation in the mouth can raise overall inflammation within the body potentially leading to serious health consequences. Numerous studies involving periodic professional interventions as well as education and training of caregivers in oral care provision have not met with a great deal of success. Caregivers in some studies have indicated preference to power toothbrushes as they are bulkier and longer eliminating the need for insertion of fingers into the mouth and subsequently alleviating fears of being bitten. This study hypothesizes that caregiver utilization of a power toothbrush may increase their compliance with daily oral care provision and could potentially result in elimination of oral and systemic inflammation.

研究设计

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

入排标准

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

入选标准

  • Residents of Nursing Home
  • Presence of any natural teeth
  • Non-aggressive behavior
  • Presence of Periodontal inflammation

排除标准

  • On a ventilator
  • Aggressive behavior
  • Presence of communicable disease
  • On antibiotics

结局指标

主要结局

Oral Inflammation

时间窗: 6 weeks

Oral inflammation will be measured at baseline and 6 weeks by means of 2 tests: The Modified Gingival Index (Lobene, 1979) and the Papillary Bleeding Score (Loesche, 1989)

Caregiver Compliance

时间窗: 6 weeks

Compliance with power toothbrushing vs standard oral hygiene care will be measured by means of a wall chart filled out by caregivers in the residents rooms.

Systemic Inflammation

时间窗: 6 weeks

Systemic inflammation will be measured using a high sensitivity C-reactive protein test (hsCRP. Blood will be drawn at baseline and at 6 weeks to facilitate this test for both intervention and control groups.

次要结局

  • Oral Plaque on Teeth(6 weeks)

研究者

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

Salme E. Lavigne

Professor

University of Manitoba

研究点 (2)

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