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临床试验/NCT05335239
NCT05335239已完成不适用

Domiciliary Professional Cleaning for Care Dependent Older Adults - A Randomized Controlled Trial

Karolinska Institutet2 个研究点 分布在 1 个国家目标入组 194 人开始时间: 2021年12月6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
194
试验地点
2
主要终点
Dental root caries

研究概览

简要总结

Keep brushing your teeth, twice a day, during life for healthy teeth and body. Not brushing your teeth regularly and well, may have a devastating effect on your teeth and your general health. The teeth could develop root caries resulting in pain, fractured teeth, tooth loss and trouble eating. Further, brushing your teeth insufficiently leads to higher number of bacteria in the oral cavity and could in frail individuals lead to aspirations pneumonias.

With age, some of us will depend on daily care activities from others and help with daily toothbrushing. However, care dependent older adults often lack basic dental care (tooth brushing with fluoride tooth paste twice a day).

Dental care at home is a service proved by dental personnel. Visits at a dental clinic decrease with age and especially with a dementia diagnosis. Dental care at home can deliver regular dental check-ups and dental treatments to individuals who experience difficulties attending a dental clinic.

The effect of teeth cleaning performed at home on root caries development, has not yet been explored in care dependent older adults. Therefore, the aim is to study if the combination of high fluoride toothpaste used daily with teeth cleaning/ a reminder to use the toothpaste every third month, could be a method for preventing root caries development in this patient group.

The hypothesis is that domiciliary professional cleaning will improve the oral health, as measured by root caries development, gingival bleeding, plaque accumulation and oral mucosal status, compared with a control group that receives oral care as usual.

详细描述

Care dependent older adults living in nursing homes have high rates of untreated root caries lesions (RCLs). RCLs, if left untreated could lead to pain, tooth loss, difficulties eating, and impacts on general health. An increasing number of research publications point to the association between poor oral health, respiratory tract infections and aspiration pneumonia. Therefore, there is a need for prevention and effective treatment among older adults, and especially those who are care dependent.

When hospitalized or being care dependent, help with care often depends on others. However, nursing assisted oral care/help with oral hygiene, is a difficult task. An effective method for preventing and treating RCLs is to brush the teeth twice a day with high fluoride toothpaste containing 5000 ppm F - . Toothpaste containing 5,000 ppm F - decreases the numbers of RCLs in comparison with ordinary toothpaste containing 1,100 - 1,450 ppm F - .

Visits at a dental clinic decrease with age and especially with a dementia diagnosis. For that reason, the service domiciliary dental care (DDC), could be an option since DDC enables dental care at home (check-ups, prophylaxis, simple tooth extractions, tooth restorations and prothesis adjustments) by dental personnel. DDC could be beneficial for the older adults, due to not having to leave home.

The effect of DDC on root caries development, has not yet been explored in care dependent older adults.

Objectives: The aim is to evaluate the effects of domiciliary professional cleaning for care dependent home living older adults. Furthermore, to contribute to increased knowledge for establishing oral health care recommendations about frequency and content for domiciliary preventive professional oral care in this patient group.

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)

盲法说明

Single - blind

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

  • Home-living older adults
  • Eligible for subsidized dental care for those with in-home care
  • Accepted oral health assessment by dental hygienists
  • Non-smokers
  • Ability to cooperate during oral assessment for 5-10 minutes
  • At least one natural tooth
  • Understand and able to communicate in Swedish.
  • Additionally: For oral microbiota, grade 1-2 according to mirror slide friction test.

排除标准

  • Edentulousness
  • Full dentures
  • Cognitive limitations that is an obstacle for cooperation
  • Malignancies and/or immunosuppressive diseases
  • Coagulation defects.
  • Anticoagulants are registered but not as an exclusion criterion.
  • Moving or planned to move to a nursing home
  • For oral microbiota: grade 3 according to mirror slide friction test

结局指标

主要结局

Dental root caries

时间窗: 12 months

Registered by the Fejerskov´s five levels root caries index at baseline and after twelve months.

Dental root caries

时间窗: 12 months

Registered by the Fejerskov´s five levels root caries index at baseline and after twelve months.

次要结局

  • Oral hygiene(12 months)
  • Gingival bleeding(12 months)
  • Oral microbiota(12 months)
  • General health(12 months)
  • Oral health-related quality of life(12 months)
  • Oral microbiota(12 months)
  • General health(12 months)
  • Oral hygiene(12 months)
  • Gingival bleeding(12 months)

研究者

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

Inger Wårdh

Associate Professor

Karolinska Institutet

研究点 (2)

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