Impact of Different Separation Methods on Proximal Contact Tightness and Contour of Compound Class ii Nanohybrid Resin Composite Restorations: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 160
- 主要终点
- Proximal Contact tightness (Success rate)
研究概览
简要总结
The aim of this study is to evaluate the interdental separation of various separation systems and their impact on the proximal contact tightness and contour in compound class II nanohybrid resin composite restorations.
详细描述
The target population consists of adult patients aged 25-40, with posterior compound proximal carious cavities (ICDS score 4 or 5) in molars. The interventions under investigation include three different separation systems: the Resin ring (DR-Resin ring, Egypt), Elliot separator (Pfingst & Co, USA), and Stainless Steel Metal ring (TOR VM ring, Russia). These systems will be compared to a Nickel titanium 3D-fusion ring (Garrison, USA). The primary outcomes assessed are proximal contact tightness and form/contour, measured visually according to FDI criteria, with scoring systems adapted from Hickel et al. (2023). Secondary outcomes, such as patient comfort (measured by a pain rating scale), and the emergence profile (assessed via bitewing radiographs), will also be considered. Data will be collected immediately postoperatively (T0), at 30 days (T1), and after 6 months (T2). The study will be conducted as a randomized clinical trial. The null hypothesis suggests that there will be no significant differences in proximal contact tightness or contour across the different separation systems used.
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)
入排标准
- 年龄范围
- 25 Years 至 40 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals with posterior compound proximal carious cavities in molars.
- •Age of (25-40) years.
- •Molars with compound proximal carious cavities score 4 or 5 ICDS.
- •Vital upper or lower posterior teeth with no signs of irreversible pulpitis.
- •Presence of adjacent and opposing teeth with normal occlusion
排除标准
- •Patients with major systemic disorders or xerostomia.
- •Patients with periodontal disease.
- •Patients with para-functional habits.
- •Presence of malocclusion or signs of pathological teeth wear
- •Non vital teeth or teeth with signs of pulpal pathology.
- •Teeth mobility or clinical attachment loss.
结局指标
主要结局
Proximal Contact tightness (Success rate)
时间窗: From enrollment to the end of treatment at 6 months
Visual examination and 25-/50-/100-µm blade according to FDI Criteria
次要结局
- Form and Contour(From enrollment to the end of treatment at 6 months)
- Patient Comfort(From enrollment to the end of treatment at 6 months)
- Emergence profile(From enrollment to the end of treatment at 6 months)
研究者
Hadeer Hesham Mohamed
Dr. Hadeer Hesham
Cairo University
