Comparison of clinical outcomes of tooth prepared using biologically oriented preparation technique and restored with CAD CAM monolithic zirconia or metal-ceramic crowns: Randomized clinical trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- 1.Total technical complications between monolithic zirconia and metal ceramic crown
研究概览
简要总结
Objectives: The purpose of this study is to compare the biological and mechanical outcomes of teeth prepared using biologically oriented preparation technique (BOPT) and restored with CAD-CAM zirconia or CAD-CAM Metal-ceramic crowns
Material and Methods: The study will be conducted as a single-center randomized clinical trial with two parallel arms. Ethical clearance will be obtained and the trial will be conducted according to the Declaration of Helsinki. Patients visiting the outpatient department of Prosthodontics will be enrolled according to the inclusion and exclusion criteria after obtaining informed/written consent. A total of 78 patients requiring single crowns in endodontically treated premolar or molar teeth will be randomized (1:1 ratio) to receive CAD-CAM Zirconia (ZIR Group) or CAD-CAM Metal Ceramic Crown (MCC Group).
The tooth will be prepared according to the BOPT protocol and immediately restored with a temporary (provisional) crown. After 4 weeks the impressions for the permanent crowns will be made. The permanent CAD-CAM zirconia or CAD-CAM metal-ceramic crowns will be fabricated in the laboratory according to the manufacturer’s instructions. The permanent crowns will be cemented with glass ionomer cement. The outcome assessment will be done by an experienced clinician who will be blinded. The clinical performance of the crowns will be assessed using revised FDI criteria for direct and indirect restorations (2023). The definitive crowns that belong to the “sufficient category†(clinically excellent, clinically good, clinically satisfactory ) in the revised FDI criteria (2023) will only be cemented others will be discarded and remade. Follow-up assessment will be done 1 week after the cementation of permanent crowns (baseline), at 6 months, 1 year, 2 years, and 3 years. Technical complications will be compared between the two groups and survival rate will be assessed using the Kaplan-Meir estimate after 1 and 3 years. The probing pocket depth, clinical attachment level, plaque index (Rustogi Modification of Navy Plaque Index 1992), and bleeding on probing (Ainamo and Bay) will be measured 1 week after the cementation of permanent crowns (baseline), at 6 months, 1 year, 2 years, and 3 years and compared with the unrestored or minimally restored contralateral control tooth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •18-45 years 2)Both males and females 3)Periodontally healthy molar or premolar teeth requiring full crowns after endodontic treatment 4)Unprepared or minimally restored contralateral tooth 5)Adequate crown-root ratio 6)Stable occlusion with a natural dentition in the opposing arch.
排除标准
- •Teeth with pre-existing periodontal diseases (probing depth more than 3 mm) 2)Patients with Bruxism 3)Poor oral hygiene 4)The tooth with a short/malformed clinical crown 5)Teeth requiring post and core 6)Uncontrolled systemic diseases 7)Smoking and tobacco use 8)Pregnant and lactating mothers 9)Patients taking drugs that interfere with bone or soft tissue healing eg: Bisphosphonates and corticosteroids.
结局指标
主要结局
1.Total technical complications between monolithic zirconia and metal ceramic crown
时间窗: Baseline, 6 months, 1 and 3 year
Sample size was calculated using the total technical outcomes of metal ceramic crown (27.1%) and zirconia crown (5.4%) obtained from a previous study, 80% power, 5% alpha error. The total sample size was 35 per group which was increased to 40 per group (total 80 patients) to adjust for 10% dropout.
时间窗: Baseline, 6 months, 1 and 3 year
次要结局
- 1. Survival analysis – between monolithic zirconia and metal-ceramic crown.(2. Comparison of the Plaque index (Rustogi Modification of Navy Plaque Index) and the Bleeding index (Ainamo and Bay).)
研究者
Dr. Ida Esther Celina
Chettinad Dental College and Research Institute