Preventive Treatment Approach of Early Caries Lesions With Contemporary Methods of Remineralization
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 主要终点
- Mean of values measured by Diagnodent(TM) (fluorescence measurement device for carious lesions) for each study group
研究概览
简要总结
The purpose of this study is to evaluate
- the additional therapeutic benefit of Curodont Repair for the treatment early occlusal carious lesions on permanent teeth in children compared fluoride varnish alone
- the tooth gel Curodont Protect when using it after Curodont Repair instead of fluoride varnish
详细描述
Objectives: The purpose of this study is to evaluate
- the additional therapeutic benefit of Curodont Repair for the treatment early occlusal carious lesions on permanent teeth in children compared fluoride varnish alone
- the tooth gel Curodont Protect when using it after Curodont Repair instead of fluoride varnish
Methods: 90 patients with early occlusal lesions (ICDAS-II:2-3) on permanent molars and pre-molars will be allocated in this randomized, controlled, single blinded study to one of the two test groups (Test1: Curodont™ Repair+Fluoride Varnish; Test2: Curodont Repair+Curodont Protect) or control (Fluoride Varnish) group.
Lesions will be assessed at baseline and recalls after 3, 6 and 12 months regarding caries activity (Nyvad), clinical status (ICDAS-II) and with Diagnodent®. Visual Analog Scale (VAS) in addition to the Global Impression of Change Questionnaire will also be used for the evaluation of the outcome.
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
- Single (Participant)
入排标准
- 年龄范围
- 6 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Early occlusal carious lesion which does not require an invasive treatment (ICDAS-II scores: 2 and 3)
- •Size and form of the lesion: the lesion must both be fully visible and assessable and accessible
- •Willing and able to attend the on-study visits and to observe good oral hygiene throughout the study
- •Written informed consent before participation in the study
排除标准
- •Evidence of tooth Erosion
- •Fluoride varnish application < 3 months prior to study treatment
- •History of head and neck illnesses (e.g. head/neck cancer)
- •Any pathology or concomitant medication affecting salivary flow or dry mouth
- •Any metabolic disorders affecting bone turnover
- •Concurrent participation in another clinical trial
结局指标
主要结局
Mean of values measured by Diagnodent(TM) (fluorescence measurement device for carious lesions) for each study group
时间窗: Day 180
Diagnodent values for fissure caries: 0-5: no demineralization, sound. 6-14: outer enamel demineralization. 15-20: inner enamel demineralization. 21-99: dentine demineralization.
次要结局
- Mean of VAS values (Visual analogue scale) for each study group(Day 90, Day 180, Day 360)
- Mean of values measured by Diagnodent(TM) (fluorescence measurement device for carious lesions) for each study group(Day 90 and Day 360)
- Frequency of change in ICDAS-II (International caries detection and assessment system) codes for each study group(Day 90, Day 180, Day 360)
- Frequency of change in caries lesion activity and severity assessed by Nyvad criteria for each study group(Day 90, Day 180, Day 360)
- Frequency of Evaluation Outcome of Global Impression of Change Questionnaire for each study group(Day 90, Day 180, Day 360)
研究者
Dafina Doberdoli
Principal Investigator
University Clinical Centre of Kosova