Biomimetic Hydroxyapatite vs Fluoride for the Domiciliary Oral Hygiene of Pediatric Patients With Asthma and/or Allergic Rhinitis: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in Shiff Air Index - Dental sensitivity test
研究概览
简要总结
The aim of the study is to compare the incidence of dental caries and the level of demineralization in pediatric patients with asthma and/or allergic rhinitis.
Patients will conduct professional oral hygiene at the baseline. The following clinical indexes will be assessed: BEWE Index, Plaque Index, Bleeding Score, Schiff Air Index. Then, patients will be randomly divided into two groups:
- Trial group: domiciliary use of Biorepair Total Protection Plus + desensitizing enamel-repair shock treatment twice a day
- Control group: domiciliary use of Elmex Caries Protection twice a day
The clinical indexes will be assessed again after 1 month (T1), after 3 (T2) and 6 months (T3).
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pediatric patients aged between 6-14 years
- •diagnosis of allergic rhinitis and asthma
- •therapy with salmeterol/fluticasone propionate
- •diffused enamel demineralizations of deciduous and permanent teeth
排除标准
- •low cooperation according to grades 3 and 4 of Frankl behavioral scale
- •nonadherence to the study protocol checked by parents
- •other systemic diseases.
结局指标
主要结局
Change in Shiff Air Index - Dental sensitivity test
时间窗: Baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3)
Scoring criteria: 0 = the subject did not respond to air blasting; 1. = the subject responded to air blasting; 2. = the subject responded to air blasting and requested discontinuation; 3. = the subject responded to air blasting, requested discontinuation and considered the stimulus to be painful.
Change in BoP - Bleeding on Probing
时间窗: Baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3)
Scoring criteria: Percentage of bleeding sites (mesial, distal, vestibular, lingual) of each teeth on the total available sites.
Change in salivary pH
时间窗: Baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3)
Use of Just Fitter strips to assess salivary pH.
Change of the BEWE Index - Basic Erosive Wear Examination (Barlet et al.2008)
时间窗: Baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3)
Scoring criteria: 0 = no erosive tooth wear; 1. = initial loss of surface texture; 2. = distinct defect, hard tissue loss \< 50% of the surface area; 3. = hard tissue loss ≥ 50% of the surface area. The BEWE will be assessed with Intact Tooth application
Change in PI - Plaque Index (Silness and Löe, 1964)
时间窗: Baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3)
Scoring criteria: 0 = no plaque; 1. = thin plaque layer at the gingival margin, only detectable by scraping with a probe; 2. = moderate layer of plaque along the gingival margin; interdental spaces free, but plaque is visible to the naked eye; 3. = abundant plaque along the gingival margin; interdental spaces filled with plaque.
Change in SI - Susceptibility Index
时间窗: Baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3)
Scoring criteria: * mild: 6.7\< pH \<7.8, BEWE 0-1, SAI 0-1 * moderate: 6.0 \<pH \<6.6, BEWE 1-2, SAI 1-2 * severe: pH \<6.6, BEWE 2-3, SAI 2-3
次要结局
未报告次要终点
研究者
Andrea Scribante
Associate Professor, Principal Investigator
University of Pavia