The Reparative Effect of Casein Phosphopeptide Amorphous Calcium Phosphate Varnish on Caries Affected Dentine in Primary Teeth (Randomized Controlled Clinical Trial)
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Evaluate the reparative ability of Casein Phosphopeptide Amorphous Calcium Phosphate varnish on caries affected dentine in primary molars.
研究概览
简要总结
Teeth selected for intervention with Atraumatic Restorative Treatment will receive Glass Ionomer restorations (control) or MI varnish (test) before receiving the Glass Ionomer restoration
详细描述
Patients selected to participate in the study will be randomly assigned into 2 groups.
Group 1 (test): who will receive casein Phosphopeptide Amorphous Calcium Phosphate (CPP-ACP) + ART in the teeth selected, excavating only the caries infected dentine and preserving the caries affected dentine.
Group 2 (control): Who will receive ART only in the teeth selected, excavating only the caries infected dentine and preserving the caries affected dentine.
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 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy patients.
- •Patients with an age range of 6-8 years old for clinical evaluation.
- •Patients ranking definitely positive or positive on Frankl scale.
- •Patients having at least 1 symptomless primary molar with caries extending to the dentine (International Caries Detection and Assessment System (ICDAS II) code 4, 5 & 6).
- •The presence of the permanent successors when examined by periapical X-ray.
- •Patients who will agree to participate in the study. For the ex-vivo sample
- •Patients with an age range of 9-11 years old.
- •The selected teeth should have more than half of their roots physiologically resorbed when examined by periapical X-ray.
排除标准
- •Patients with special health care needs (physical, mental or medical).
- •Primary molars that are mobile, ankylosed or have periapical pathology on initial examination clinically and radiographically.
研究组 & 干预措施
Control (ART)
in this group, teeth selected will receive restorations with light cured Glass Ionomer restorations after excavating the carious lesions preserving the caries affected dentine using the ART
干预措施: Atraumatic restorative treatment (Procedure)
Test (ART + CPP-ACP)
In this group, teeth selected will receive intervention with CPP-ACP and restorations with light cured Glass Ionomer restorations after excavating the carious lesions preserving the caries affected dentine using the ART
干预措施: Casein phosphopeptide amorphous calcium phosphate (Drug)
Test (ART + CPP-ACP)
In this group, teeth selected will receive intervention with CPP-ACP and restorations with light cured Glass Ionomer restorations after excavating the carious lesions preserving the caries affected dentine using the ART
干预措施: Atraumatic restorative treatment (Procedure)
结局指标
主要结局
Evaluate the reparative ability of Casein Phosphopeptide Amorphous Calcium Phosphate varnish on caries affected dentine in primary molars.
时间窗: 12 months
this is by evaluating the clinical and radiographic data and also by descriptive histological assessment
次要结局
未报告次要终点
研究者
Hams Hamed Abdelrahman
Assistant lecturer
Alexandria University