"Evaluation of Clinical Performance of a Flowable Bulk Fill Composite Resin Versus a Highly Viscous Glass Ionomer Cement in Class II Cavities in Primary Molars: A Randomized Clinical Trial"
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- clinical performance
研究概览
简要总结
evaluate the clinical performance of EQUIA Forte ® ( a HVGIC) and Plafique® Bulk Flow composite resin when placed in class II cavities in primary molars.
详细描述
- Thorough diagnosis of patients will be done by the primary investigator. Patients with class II carious primary molars with score 4 or 5 using the International Caries Detections and Assessment Criteria (ICDAS).
- Pre-operative bitewing radiographs will be obtained to assess the depth of the cavity. Primary molars with score D1 or D2 according to the ADA will be included in the study.
- Each patient will be assigned to one of the two groups.
- Group I (n= 59): Plafique Bulk Flow Composite.
- Group II (n=59): EQUIA Forte Group.
- Class II carious primary molars are prepared using 330 burs. The cavity will be approximately with a depth of 0.5 mm in dentin and width of at least one-third of the occlusal table. Outline of the cavity will be determined by the extent of the carious lesion. No beveling will be done in any of the cavities.
- Matrix is placed and secured in position.
- One of the 2 restorative materials is placed in the cavity using the manufacturer's instructions.
- Patients will be recalled at 3, 6, and 12 months to evaluate the restoration clinically using the FDI criteria.
- Patients will receive oral health education on how to maintain a proper oral hygiene and proper diet consumption.
- They will be given manual tooth brushes and tooth pastes to use during the study.
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
- 4 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Four to 8 years old children
- •Cooperative children classified as class 3 or 4 based on Frankle et al. classification.
- •Presence of deep bite or any type of malocclusion or parafunctional habits.
- •Children who have at least one primary molar with active proximal caries (score 4 or 5 using ICDAS).
排除标准
- •Refusal of the parents to sign the informed consent.
- •Presence of deep bite or any type of malocclusion or parafunctional habits.
结局指标
主要结局
clinical performance
时间窗: one- year
Evaluate and compare the clinical performance of two commercially available bulk restorative materials (Plafique® Bulk Flow Composite and EQUIA Forte®) for 12 months using the Federation Dentaire Internationale (FDI) criteria when placed in class II cavity in primary molars. This diagnostic system classified aesthetic, functional, and biological properties and covers various types of failures by using 16 different categories with five grades for each criterion. Where score 1 indicates clinically excellent/very good (sufficient), 2: clinically good (sufficient), 3: Clinically satisfactory (sufficient), 4: Clinically unsatisfactory (partially insufficient), and finally score 5 indicates clinically poor (entirely insufficient)
次要结局
未报告次要终点
研究者
Mariam Mohamed Abdel Azim
Assistant lecturer
Ain Shams University