Effects of Biomimetic Hydroxyapatite in the Treatment of Molar Incisor Hypomineralization: a Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Change of PCR - Plaque Control Record (O'Leary, 1972)
研究概览
简要总结
The aim of the following study is to evaluate che clinical efficacy of a toothpaste with biomimetic hydroxyapatite for the management of Molar-Incisor Hypomineralization. Patients who agree to participate to the study will use Biorepair toothpaste for the first 7 days of the month for 3, 6 and 9 months. The following indices will be measured: BEWE, Bleeding Index, Gingival index, Plaque index and the dental sensitivity test. The contralateral tooth will be used as control if not affected by MIH; otherwise, adjacent teeth will be considered.
详细描述
Informed consent will be signed by the parents of the patients underage; patients will be asked the approval for the attendance of the study.
Adult patients will sign the informed consent for the treatment and for processing personal data for research purpose, with their approval for the attendance of the study.
Patients will be given for free a toothpaste with biomimetic hydroxyapatite (Biorepair Enamel-Repair Shock Treatment) and the Investigator will explain the correct procedures for home oral care. The toothpaste will be applied the first 7 days of the month for 9 months with a specific tray.
Teeth will be randomly assigned to:
- Trial group: 1 tooth with MIH from 1 quadrant will be treated with the biomimetic hydroxyapatite toothpaste. The applications will be performed for the first 7 days of the month for 9 months (1 application per day that lasts 10 minutes).
- Control group: 1 contralateral tooth with MIH will not be treated with the biomimetic hydroxyapatite toothpaste Patients will be visited after 1, 2, 3, 6 and 9 months from the baseline. For each visit, BEWE index, Bleeding Index, Gingival index, Plaque index and Dental sensitivity test. Tooth with MIH will be assessed, together with its contralaterals as control. If the contralateral tooth should suffer from MIH too, measurements will be carried out on the adjacent tooth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •presence of at least 2 enamel demineralizations of permanent molars and incisors (Molar-Incisor Hypomineralization - MIH) in contralateral quadrants
- •good general health (absence of systemic diseases)
排除标准
- •patients undergoing orthodontic therapy
- •patients taking drugs
结局指标
主要结局
Change of PCR - Plaque Control Record (O'Leary, 1972)
时间窗: Study begin, 1,2,3, 6 and 9 months
4 surfaces scored (mesial, distal, vestibular, labial/palatal) per tooth by means of plaque relevator. The Index is calculated multiplying the total number of surfaces with plaque per 100.
Change of BEWE Index - Basic Erosive Wear Examination (Barlet et al., 2008)
时间窗: Study begin, 1,2,3, 6 and 9 months
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. Additionally, risk level for clinical management will be assessed.
Change of BI - Bleeding Index
时间窗: Study begin, 1,2,3, 6 and 9 months
Scoring criteria: * 0: absence of bleeding after 30 seconds * 1: bleeding observed after 30 seconds * 2: immediate bleeding
Change of GI - Gingival Index (Loe and Silness, 1963)
时间窗: Study begin, 1,2,3, 6 and 9 months
Scoring criteria: * 0 = normal gingiva. * 1 = mild inflammation, edema and swelling; no bleeding. * 2 = moderate inflammation with edema, swelling and bleeding on probing. * 3 = severe inflammation with marked edema, redness tissues, ulceration and spontaneous bleeding.
Change in Schiff Air Index - Dental sensitivity test
时间窗: Study begin, 1,2,3, 6 and 9 months
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.
次要结局
未报告次要终点
研究者
Andrea Scribante
Research Resident, Principal Investigator
University of Pavia