Comparative Clinical and Radiographic Evaluation of Casein Phosphopeptide Amorphous Calcium Phosphate Under Glass Ionomer in Atraumatic Restorative Treatment Versus Conventional Atraumatic Restorative Treatment in Primary Teeth: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Post-operative pain
研究概览
简要总结
To evaluate the clinical and radiographic success of using Casein Phosphopeptide Amorphous Calcium Phosphate (CPP-ACP) under glass ionomer restorations in atraumatic restorative treatment as a biomimetic approach in pediatric dentistry.
详细描述
With the growing popularity of ART in the field of pediatric dentistry, a great deal of research has been done in recent years. Researchers are keen to explore the rich possibilities and variations of ART technique that can help doctors practice better and do more for their patients. Alternatives include detours to regenerative dentistry, which is becoming more and more popular these days.
CPP ACP is still of great interest in the region due to its remineralizing action. However, to our knowledge, clinical and radiological success involving tissue regeneration by CPP-ACP is understudied. Furthermore, the studies conducted justify the need for further research on the use of CPP-ACP as an indirect material under glass ionomers in ART. Therefore, this study aims to conclude whether CPP ACP has added value in regenerating, reducing pain, and improving repair retention in caries-affected dentin lesions.
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, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical Criteria:
- •Children aged 4-7 years. Apparently healthy children. Children with mild to moderate occlusal carious lesions in the mandibular second primary molar indicated for indirect pulp capping.
- •No history of spontaneous pain, pathologic mobility, draining sinus tract, redness or swelling of vestibule.
- •Normal gingival and periodontal condition, with no sensitivity to vestibular palpation, and no pain on percussion test.
- •Radiographic criteria:
- •No sign of radiolucency in periapical or furcation area.
- •No widening of PDL space or loss of lamina dura continuity.
- •No evidence of internal/external pathologic root resorption.
排除标准
- •Uncooperative children to avoid time waste and attrition bias.
- •Children with systemic disease as some systemic diseases may have effect on the outcome Children with known allergy to any of the components being utilized. Molars near exfoliation.
- •Primary molars with more than half of the root resorbed or with periapical pathology as evident radiographically Mobile or ankylosed molars with no permanent successors
- •Unable to attend follow-up visits to avoid attrition bias by decreasing number of drop off cases.
- •Refusal of participation as the parent of child has the authority of participation.
结局指标
主要结局
Post-operative pain
时间窗: 12 months
Verbal question to the patient form score 0-5 where o is no pain and maximum pain indicates 5
Marginal integrity
时间窗: 12 months
Visual and clinical examination (by probe and mirror or any change in color or breakage of restoration, recurrent caries as direct observation) from score 0-5 where 0 gap free marginal interface, 1 indicates mircoleakage occur in 1 surface, 2 in 2 surfaces, 3 in 3 surfaces, 4 in 4 surfaces, 5 loss of whole restoration.
次要结局
- Absence of furcation or periapical radiolucency(12 months)
- Absence of any internal or external root resorption(12 months)