Evaluation of IPS E.Max-CAD Endocrown in Molars Compared to the Conventional Design
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Change in Marginal Adaptation
研究概览
简要总结
Background: no randomized controlled trial has tried to compare treatment outcomes between the IPS.emmax endocrowns and the IPS.emmax conventional crowns .
Objective: to investigate the clinical performance of the IPS.emmax endocrowns and the IPS.emmax conventional crowns Design and setting: Parallel-groups randomized controlled trial on patients with one or more intensive damaged molars requiring crowning and being treated at the University of Damascus, Dental School in Damascus, Syria .All molars will be examined at the baseline assessment using a modified US Public Health Service (USPHS) criteria.
Participants: Incoming patients to the Fixed Prosthetic and Endodontic Departments will be examined to find any excessively damaged molars requiring crowning. Forty patients will be recruited according to specific inclusion criteria. Randomization will be performed using computer-generated tables; allocation will be concealed using sequentially numbered opaque and sealed envelopes.The included 40 patients will be analyzed (age range between 20-60 years). They will be randomly distributed into two groups with 20 patients in each group (1:1 allocation ratio).
Intervention: Excessively damaged and endodontically treated molars will be restored with IPS.emmax endocrowns or IPS.emmax crowns supported with composite core.
Main outcome measure: marginal adaptation and anatomic form will be investigated clinically and by apical radiographs at the baseline assessment using the modified (USPHS) at six assessment times during an 18-month observation period.
Assessor blinding will be employed.
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
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 20 to 60 years old
- •Good oral hygiene
- •Gingival index (GI) equal 0
- •Plaque index (PI) equal 0 or 1
- •Primary acceptation and commitment to the trail
- •Inclusion criteria of molars:
- •Two remaining axial walls at least.
- •0.5 mm above the gingival line at least for damaged axial walls.
- •Good endodontic treatment and apical seal
- •First and second upper and lower molars only.
- •Against teeth could be natural or crowned.
排除标准
- •Patients with an open bite or cross bite.
- •Periodontitis
- •Gingival hyperplasia
结局指标
主要结局
Change in Marginal Adaptation
时间窗: at 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 15 months (T5), and 18 months (T6) following application
The presence of marginal adaptation means that the restoration margins cannot be distinguished, the probe cannot find a step between the margins and the surrounding tissue, and no discoloration visible.
Change in the Anatomic Form
时间窗: at 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 15 months (T5), and 18 months (T6) following application
The anatomic form is considered satisfactory when the crown has a correct contour with tight proximal contact, no worn facets on restorations and no worn facets on opposing teeth.
次要结局
- Change in the Retention Status(at 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 15 months (T5), and 18 months (T6) following application)