Effectiveness of Zirconia-based Crowns With Retention Grooves (Sprig EZ) Versus Without Retention Grooves (NuSmile ZR) for Restoration of Primary Anterior Teeth: A Parallel-arm Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Success of prefabricated Zirconia-based primary anterior crowns with retention grooves compared to Zirconia-based primary anterior crowns without retention grooves through clinical outcomes
研究概览
简要总结
The purpose of this research study is to test the effectiveness of two different crowns/caps on teeth for restoration of primary anterior teeth. The two different materials of crowns are esthetic crowns with retentive grooves and without retentive crowns. These crowns are placed on the teeth to restore function, esthetics and prevent further caries and infection.
详细描述
There are many treatment options available for restoring primary anterior teeth. A clinician's decision to opt for any specific treatment option is based on multiple factors such as the clinician's liking of a specific material or method, esthetic demands by parents, the child's behavior, and moisture and hemorrhage control. Out of many treatment options, preformed zirconia crowns for primary teeth have been available for over a decade. There is insufficient research that compares the success of anterior pediatric zirconia crowns with and without retentive grooves.
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, Care Provider)
入排标准
- 年龄范围
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy 2 to 6-year-old children.
- •Those having opposed anterior teeth.
- •No history of systemic illness or dental developmental anomalies
- •Minimal of two surfaces of caries in the upper anterior teeth.
- •Patient with Early Childhood Caries.
- •Patients treated under General Anesthesia.
- •English, Spanish, and Arabic speaking patients
排除标准
- •Teeth nearing exfoliation.
- •The presence of a single surface caries, not involving the proximal surfaces.
- •Teeth that have been subjected to trauma.
- •Special health needs.
- •Presence of teeth wear on the opposing teeth, or absence of opposing teeth.
结局指标
主要结局
Success of prefabricated Zirconia-based primary anterior crowns with retention grooves compared to Zirconia-based primary anterior crowns without retention grooves through clinical outcomes
时间窗: 3, 6, 12, 24 and 36 months
The clinical outcomes will be measured and reported in the data table based on the number of participants scored on 3-point Likert scale (Ideal, Acceptable, or Not Acceptable) for the following parameters separately: Contour of crown, Gingival health, Staining of crown, Surface roughness of crown, Opposing tooth, Color match of crown, Marginal fit, Marginal discoloration, Recurrent caries.
Success of prefabricated Zirconia-based primary anterior crowns with retention grooves compared to Zirconia-based primary anterior crowns without retention grooves through radiographic outcomes
时间窗: 3, 6, 12, 24 and 36 months
The radiographic outcomes will be measured and reported in the data table based on the number of participants scored on either presence or absence (yes/no) of the findings for the following parameter separately: Widening of periodontal ligament space, periapical pathology, alveolar crestal bone loss, internal root resorption and external root resorption.
次要结局
- Parental satisfaction(3, 12, 24 and 36 months)
- Child satisfaction(3, 12, 24 and 36 months)
- Oral health impact during early childhood(3, 12, 24 and 36 months)