Clinical and Radiographic Assessment of Injectable Composite Versus Packable Composite in the Restoration of Cavitated Primary Molars a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Clinical Assessment of Injectable Composite Versus Packable Composite in The Restoration of Cavitated Primary Molars
研究概览
简要总结
This randomized clinical trial aims to compare the clinical and radiographic performance of injectable composite versus packable composite in restoring cavitated primary molars in children aged 4 to 8 years.
Study Purpose
To determine whether injectable composite performs as well as packable composite in Class II restorations in primary molars clinically and radiographically.
详细描述
This randomized clinical trial aims to compare the clinical and radiographic performance of injectable composite versus packable composite in restoring cavitated primary molars in children aged 4-8 years.
Study Purpose
To determine whether injectable composite performs as well packable composite in Class II restorations in primary molars.
Study Design
Type: Randomized clinical trial
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
- Double (Participant, Outcomes Assessor)
盲法说明
outcome assessors
入排标准
- 年龄范围
- 4 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients:
- •Children aged 4-8 years.
- •Medically free.
- •Restorable Class II cavities.
- •Asymptomatic tooth.
- •Pre-operative radiographic examination:
- •Absence of periapical or inter-radicular radiolucency.
- •Absence of widening of periodontal ligaments space.
- •Absence of internal or external root resorption.
排除标准
- •Patients:
- •Uncooperative children.
- •Unable to attend follow-up visits.
- •Parents refuse to sign the informed consent.
- •Children participating in any other clinical trial involving fluoride therapy or other interventions that could directly influence caries development during the study period.
- •Teeth which were previously restored.
- •Mobility.
- •Pre-operative radiographic examination:
- •Caries extending deep sub-gingivally.
- •The tooth is about to exfoliate.
研究组 & 干预措施
injectable composite
it is a type of zero flow injectable composite used to restore teeth and molars
干预措施: injectable composite (Other)
Packable composite
composite used to restore molars
干预措施: packable composite (Other)
结局指标
主要结局
Clinical Assessment of Injectable Composite Versus Packable Composite in The Restoration of Cavitated Primary Molars
时间窗: Time: T0 = baseline assessment and procedure will be done. T1 =3 months follow up. T2 = 6 months follow up. T3 = One-year follow-up.
Clinical evaluation will be done according to Fédération Dentaire Internationale FDI criteria Scores: Clinically excellent = 1 Clinically good = 2 Clinically sufficient = 3 Clinically unsatisfactory = 4 Clinically poor = 5
次要结局
- Radiographic Assessment of Injectable Composite Versus Packable Composite in The Restoration of Cavitated Primary Molars.(t = 0 months t2 = 6 months t3 = 12 months)
研究者
Eslam samy abdel monaem kalboush
Assistant lecturer in pediatric dentistry department delta university
Cairo University