Clinical Evaluation of Cerasmart Implant-supported Posterior Crowns
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Gingival Index (GI) at baseline
研究概览
简要总结
The objectives of the present study are to analyze and to compare the survival rates and possible biological and technical complications arising from the use of composite-ceramic posterior implant-supported crowns with those obtained when using their counterparts prepared using monolithic zirconia restorations. The null hypothesis is that no differences would be found between the parameters studied for each type of restoration.
详细描述
Eighty patients in need of posterior implant-supported crowns (n=80) were recruited from the Master of Buccofacial Prostheses and Occlusion, Faculty of Odontology, University Complutense of Madrid, Madrid, Spain. Before treatment, all participants were informed of the purpose of the study, the clinical procedures, the material to be used, and the advantages and risks of the restorations. They were asked to give their written informed consent to participate in the study.
Eighty posterior implant-supported crowns were produced and allocated in parallel an randomly to either monolithic zirconia or composite-ceramic restorations by means of a randomization list. A total of 40 implant-supported crowns were placed using monolithic zirconia and 40 composite-ceramic. The clinical procedures were performed by two experienced clinicians. Full-arch impressions were taken using addition silicone. The restorations were cemented using a resin-based cement. The occlusion was adjusted and the surfaces polished after cementing. All restorations were prepared by an experienced technician. The restorations will be examined at one week (baseline), 1, 2, and 3 years by two researchers who were not involved in the restorative treatment. Each assessor evaluated the restoration independently, and the worst assessment will be used in the event of discrepancies.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •One posterior tooth (molar or premolar) to restore, and with opposing tooth
排除标准
- •unacceptable oral hygiene
结局指标
主要结局
Gingival Index (GI) at baseline
时间窗: Baseline
Gingival Index (GI) of the abutment and control teeth. A score of 0 to 3 was assigned. Higher score means a worse outcome.
Gingival Index (GI) at 1 year
时间窗: 1 year
Gingival Index (GI) of the abutment and control teeth. A score of 0 to 3 was assigned. Higher score means a worse outcome.
Plaque Index (PI) at 1 year
时间窗: 1 year
Plaque Index (PI) of the abutment and control teeth. A score of 0 to 3 was assigned. Higher score means a worse outcome.
Plaque Index (PI) at 3 years
时间窗: 3 years
Plaque Index (PI) of the abutment and control teeth. A score of 0 to 3 was assigned. Higher score means a worse outcome.
Gingival Index (GI) at 3 years
时间窗: 3 years
Gingival Index (GI) of the abutment and control teeth. A score of 0 to 3 was assigned. Higher score means a worse outcome.
Probing depth at baseline
时间窗: Baseline
Probing depth of the abutment. A score of 0 to 4 was assigned. Higher score means a worse outcome
Probing depth at 3 year
时间窗: 3 years
Probing depth of the abutment teeth. A score of 0 to 4 was assigned. Higher score means a worse outcome
Quality of restorations at 1 year
时间窗: 1 year
The quality of the surface and color, anatomical form and marginal integrity was assessed using the California Dental Association's (CDA) assessment system. Each CDA criterion was ranked on a scale of 1 to 4, where 4 = excellent, 3 = good, 2 = unacceptable (repair), and 1 = unacceptable (replacement).
Plaque Index (PI) at baseline
时间窗: baseline
Plaque Index (PI) of the abutment and control teeth. A score of 0 to 3 was assigned. Higher score means a worse outcome.
Gingival Index (GI) at 2 years
时间窗: 2 years
Gingival Index (GI) of the abutment and control teeth. A score of 0 to 3 was assigned. Higher score means a worse outcome.
Probing depth at 2 year
时间窗: 2 years
Probing depth of the abutment. A score of 0 to 4 was assigned. Higher score means a worse outcome
Quality of restorations at baseline
时间窗: Baseline
The quality of the surface and color, anatomical form and marginal integrity was assessed using the California Dental Association's (CDA) assessment system. Each CDA criterion was ranked on a scale of 1 to 4, where 4 = excellent, 3 = good, 2 = unacceptable (repair), and 1 = unacceptable (replacement).
Quality of restorations at 2 year
时间窗: 2 years
The quality of the surface and color, anatomical form and marginal integrity was assessed using the California Dental Association's (CDA) assessment system. Each CDA criterion was ranked on a scale of 1 to 4, where 4 = excellent, 3 = good, 2 = unacceptable (repair), and 1 = unacceptable (replacement).
Quality of restorations at 3 year
时间窗: 3 years
The quality of the surface and color, anatomical form and marginal integrity was assessed using the California Dental Association's (CDA) assessment system. Each CDA criterion was ranked on a scale of 1 to 4, where 4 = excellent, 3 = good, 2 = unacceptable (repair), and 1 = unacceptable (replacement).
Plaque Index (PI) at 2 years
时间窗: 2 years
Plaque Index (PI) of the abutment and control teeth. A score of 0 to 3 was assigned. Higher score means a worse outcome.
Probing depth at 1 year
时间窗: 1 year
Probing depth of the abutment. A score of 0 to 4 was assigned. Higher score means a worse outcome
次要结局
未报告次要终点