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临床试验/NCT02669979
NCT02669979已完成不适用

Domiciliary Professional Oral Care for Dependent Elderly - Access to Improved Oral and General Health?

Karolinska Institutet1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2016年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
1
主要终点
Changes from baseline in bleeding on probing (BoP) each third month

研究概览

简要总结

Today's increase of dentate elderly, many of them dependent, is a challenge, both according to the personal daily oral hygiene and dentistry. This is not only an oral problem, as research findings point to strong associations between oral and general health, even mortality. These findings are especially noticeable in elderly and frail individuals.

Dental care is usually performed in stationary dental clinics where the patients are transported to receive treatment. Dependent elderly dental patients may present many obstacles to traditional dental care due to cognitive limitations or dementia, mobility or transport problems. An alternative is domiciliary dental care where the dental staff performs the treatment by a home visit, in the patients daily living environment. The ability to handle personal oral hygiene is often decreased in these patients and left to overburdened nursing staff that often also lack sufficient knowledge about oral health care, why prophylactic professional oral care is especially important. This type of care can with rather simple equipments be performed as domiciliary treatment of good quality, while more advanced dental care may present restrictions in the home environment. However, in the Swedish dental system with subsidized dental care for dependent and elderly patients, there are restrictions for the number of prophylactic oral care treatments. The levels vary in different counties and regions. The rationale for this is probably tradition and economy as scientific evidence is lacking.

The aim with this project is to develop domiciliary professional oral care. The researchers will compare the effect of different regimens for domiciliary prophylactic professional oral care both according to content and frequency. The overall aim is to establish relevant recommendations for domiciliary prophylactic professional oral care.

详细描述

Background:

An increasing number of research publications point to the association between oral and general health. There are reports about associations between oral infections, coronary diseases, diabetes and respiratory tract infections but also between a high oral opportunistic micro flora and increased mortality in frail elderly individuals. It is important to develop oral care methods that effectively prevent the growth of an opportunistic micro flora and och oral diseases. Especially important is preventive methods in old and dependent individuals as these vulnerable patients groups have limited possibilities and access to relevant oral health care.

Professional oral care have been seen as an effective method to prevent dental diseases as caries and periodontal problems in elderly but in the new National guidelines for dentistry there is pointed to that there are no scientific proof for the effect of professional oral care, besides ordinary daily oral care in grownups. This conclusion could not be translated to frail elderly who are dependent on help from the nursing staff to receive or perform daily oral hygiene. The effect of domiciliary oral care have to our knowledge, not been explored. This type of care can with rather simple equipments be performed with good quality, while more advanced dental care may present more restrictions in the home environment. However, in the Swedish dental system with subsidized dental care for dependent and elderly patients, there are restrictions for the number of prophylactic oral care treatments. The levels vary in different counties and regions. The rationale for this is probably tradition and economy as scientific evidence is lacking.

Aim:

The aim is to develop and evaluate domiciliary prophylactic professional oral care. The researchers will compare the effect of different regimens for domiciliary prophylactic professional oral care on oral health in dependent elderly, both according to content and frequency. The overall aim is to to establish relevant recommendations for domiciliary prophylactic professional oral care.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
80 Years 至 95 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 10 or more natural teeth or fixed teeth inclusively osseointegrated implants
  • non smokers,
  • no or mild cognitive impairments
  • Exclusion criteria:
  • severe cognitive impairments
  • edentulousness and full dentures
  • malignancies and/or immunosuppressive diseases, coagulation defects.
  • Anticoagulants will be registered but not as an exclusion criteria.

排除标准

  • 未提供

研究组 & 干预措施

Intervention

Experimental

Intervention in the research groups is professional oral care with tooth brush, "ordinary" fluoridated tooth paste (1100-1450 ppm NaF), and repeated oral care instruction to participants and staff (contact person) , supra gingival depuration if necessary. The group receive treatment each month.

干预措施: Intervention (Other)

Control

No Intervention

Care as usual. Common oral hygiene help administered by nursing staff.

结局指标

主要结局

Changes from baseline in bleeding on probing (BoP) each third month

时间窗: 12 months

Primary effect variable: bleeding on probing (BoP) in the gingival sulcus on buccal surfaces concerning the teeth 13, 12, 11, 21, 23, and 33, 32, 31, 41, 43 or the nearest comparable teeth. The bleeding will be scored at four levels (0-3) due to Modified Sulcus Bleeding Index. The measurements are performed at baseline and each third month up to 12 months in both study groups. Comparison will be made on group level.

次要结局

  • Changes from baseline in caries each third month(12 months)
  • Changes from baseline in Oral hygiene, each third month(12 months)
  • Changes from baseline in oral micro flora, each six month(12 months)

研究者

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

Inger Wårdh

PhD Associate professor

Karolinska Institutet

研究点 (1)

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