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临床试验/NCT02647203
NCT02647203已完成1 期

Non-invasive Therapy With Fluoridated Toothpastes for Root Caries in Independently-living Older Adults

University of Talca1 个研究点 分布在 1 个国家目标入组 345 人开始时间: 2014年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
345
试验地点
1
主要终点
Root Caries Activity

研究概览

简要总结

This study aims to test the effectiveness in reducing or arresting root caries lesion in community-dwelling elderly subjects by using high fluoridated toothpaste. A double blinded RCT will be conducted with two arms; 5000 ppm F and 1450 ppm F toothpaste. Dentifrices will be delivered to the participants in a blind format and they will be instructed to brush twice per day.

Follow-up will be carries out every 6 months for two years to assess:

  • Root caries incidence.
  • Lesion arresting
  • Changes in salivary flow
  • Microbiology pattern shift
  • Variations in oral health- related quality of life by OHIP-14 Sp

详细描述

Background. Caries of the root surface (root caries) is the most prevalent type of dental caries in older adults with a reportedly worrisome trend to increase, as more teeth are being retained. Dental caries is the leading causes of tooth loss among older adults. Fluoride has been successfully used in preventive programs for root caries. In addition to preventing root caries, fluoride-based therapies may be used to treat lesions. This approach is known as non-invasive treatment. Fluoride seems to arrest and promote remineralization of the lesions. Indeed, recent studies appear to indicate that, higher fluoride concentrations are more effective to prevent and to treat the disease. Dentifrices with high concentrations of fluoride appear to be the most rational approach to prevent and treat root caries. To the chemical effect of fluoride, toothbrushing adds mechanical removal of the dental biofilm. High concentration fluoride varnishes have also been proposed as effective in treating carious lesions. Whether dentifrices, varnishes or the combined use of varnish and fluoridated toothpaste result more effective is a matter of controversy and it needs to be elucidated. Non-invasive treatment avoids the complications inherent to treating frail people in a dental setting, decrease costs and importantly, allows increased coverage, as these therapies may be delivered by non-dentist personnel. Although the appealing idea of non-invasive treatment of root caries in older adults, evidence is still limited and more research appears necessary to both, confirm clinical success and elucidate the mechanisms involved in lesion arrestment.

Aim. To determine the effectiveness of non-invasive therapies for root caries and their impact in the quality of life of older adults.

Methodology. A double blind randomized controlled trial (RCT) on independently-living older adults aged sixty or more years is proposed. Subjects will undergo clinical and microbiological examination when recruited (baseline) with a six-month follow-up regime until completion of two years. To participate, subjects will have to have at least five teeth with exposed root surfaces and one carious lesion. Sample size was calculated and a sample of two-hundred and eighty-eight older adults is necessary, randomized into two study arms;

Group 1: toothpaste 1.450 ppm F-

Group 2: toothpaste 5.000 ppm F-

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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

  • 60 + years old
  • community-dwelling
  • living in a community with fluoridated water
  • had five or more of their own teeth
  • with ≥ 1 root caries lesion

排除标准

  • cognitive impairment
  • alcoholism

研究组 & 干预措施

High Fluoride Toothpaste

Experimental

5,000 ppm fluoridated toothpaste, high concentration. Self-administered fluoridated dentifrices. By the elderly subjects, twice per day Drug (including placebo)

干预措施: Self-administered fluoridated dentifrices (Drug)

Standard Fluoride Toothpaste

Active Comparator

1,450 ppm fluoridated toothpaste, low concentration. Self-administered fluoridated dentifrices. By the elderly subjects, twice per day Drug (including placebo)

干预措施: Self-administered fluoridated dentifrices (Drug)

结局指标

主要结局

Root Caries Activity

时间窗: After 2 years of follow up

Using Nyvad's criteria for root caries lesions, activity will be assessed by a visual-tactile method.

次要结局

  • Oral Health Related Quality of Life, Measured by the Oral Health Impact Profile (OHIP-14 Sp)(Data registered at 2 years of follow-up)
  • Salivary Flow(Baseline and 2-year follow up)

研究者

发起方
University of Talca
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rodrigo A. Giacaman, DDS, PhD

Associate Professor

University of Talca

研究点 (1)

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