Clinical Comparison Between Zirconia Crowns Versus Anterior Strip Crowns
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 主要终点
- Gingival Health
研究概览
简要总结
The hypothesis to be investigated is that no difference will be found upon comparing resin composite strip crowns and NuSmile zirconia crowns (NuSmile ZR) esthetic primary anterior in restoring anterior primary teeth.
详细描述
The aim of this study is to clinically evaluate the performance of a new NuSmile ZR esthetic primary anterior crowns, compared with anterior resin composite strip crowns in the restoration of 120 teeth (primary incisors and lateral anterior teeth in the deciduous dentition of child patients).
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
- None
入排标准
- 年龄范围
- 4 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Children with no history of any systemic illness or any developmental disease of the teeth and jaws that would have affected dietary patterns, caries, susceptibility or the selection of restorative materials to the best of current knowledge.
- •Minimal of two surfaces of caries in the targeted tooth.
- •Patient with Early Childhood Caries as defined by American Academy of Pediatric Dentistry (AAPD),
- •Cooperative patient who had behavioral rating "positive" or "definitely positive" followed the Frankl behavior classification scale. (Frankl et al. 1962)
- •Opposing teeth present.
- •Written consent was obtained from the parent/guardian after explaining the full details of the treatment procedure and its possible outcomes, discomfort, risks, and benefits.
- •No patient was excluded on the basis of gender, race, social or economic background.
排除标准
- •Teeth with proximity to exfoliation and resorption of the root passed its half.
- •Patients with allergy or hypersensitivity to nickel in case of posterior group teeth.
- •Presence of single surface caries not involving the proximal surfaces.
- •Teeth that has been subjected to trauma.
- •Anxious, uncooperative patients who need to be treated under general anesthesia.
- •Children who suffer from bruxism.
- •Children with special needs.
- •Presence of tooth wear on the opposing teeth (in case of anterior teeth), or absence of opposing.
结局指标
主要结局
Gingival Health
时间窗: 12-month follow-up
This parameter was evaluated using a blunt periodontal probe (Double ended probe Williams 1-2-3-5-7-8-9-10 Goldman Fox Flat) according to the Löe and Silness gingival index \[Löe, 1967\].
Plaque index
时间窗: 12-month follow-up
This parameter was evaluated using a blunt periodontal probe (Double ended probe Williams 1-2-3-5-7-8-9-10 Goldman Fox Flat) according to the Löe and Silness gingival index \[Löe, 1967\].
Restoration failure
时间窗: 12-month follow-up
This was clinically evaluated with visual assessment of the restoration, according to the US Public Health Service "USPHS", Alpha criteria rating system \[Ryge, 1980\].
Tooth wear of opposing dentition
时间窗: 12-month follow-up
Tooth wear was evaluated according to the Smith and Knight Tooth Wear Index (Bardsley, 2008; Smith and Knight, 1984)
次要结局
未报告次要终点
研究者
Bashaer S. Abdulhadi
Dr. Bashaer Abdulhadi
King Abdulaziz University