Influence of Luting Cement on the Clinical Outcomes of Zirconia Pediatric Crowns. A 3 Year Split-Mouth Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 主要终点
- Number of debonded crowns
研究概览
简要总结
The purpose of this split-mouth study was to compare the efficacy of using Bio-active cement versus Packable glass ionomer for cementation of posterior zirconia pediatric crowns.
详细描述
Restoration of pulp treated or badly broken down deciduous teeth with full coverage restoration have shown superior success rate to all other restorative materials.
Restoration of deciduous teeth with esthetic full coverage restoration has been a challenging aim especially for the more functionally loaded posterior teeth. Due to the continuous increase in socio-economic standards; restoring posterior teeth with esthetic restoration is on high demand nowadays.
The recently introduced zirconia pediatric crowns have been very promising in terms of strength and toughness. Clinical trials on maxillary incisors have shown very high success rates in terms of retention and gingival health.
The problem of restoring posterior deciduous teeth with pre-fabricated zirconia crowns is that its retention is only and totally dependent on luting cement, in addition to the problem of the deteriorated gingival condition around crowns in general.
Being recently introduced to the market; there have not been any clinical trials studying retention of zirconia posterior pediatric crowns published yet.
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 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •4-7 years old patients having two contra-lateral mandibular first primary molars indicated for restoration with crowns.
- •Presence of sound tooth structure at the cervical margins of the teeth.
- •Presence of opposing functioning teeth.
- •Included teeth should be assessed clinically as free from active pulpal or periodontal conditions.
- •Patient must be in general good health, with no medical contraindication to dental treatment.
- •Patient must be available for required recalls as outlined in the protocol.
排除标准
- •Teeth with defects like hypoplasia or hypocalcification.
- •Patients with untreated periodontal disease.
- •Patients with any pathological or systemic problems that would not allow the dental procedures in this study to take place.
- •Teeth that exhibit mobility.
- •Patients that show signs of severe bruxism or teeth clenching.
- •Subjects with deleterious oral habits like pencil/pen chewing.
- •Uncooperative patients.
研究组 & 干预措施
Bio-active cement
Bio-active cement dispensed into the crown, and the crown was properly positioned over the tooth, cement was allowed to self-set for 20 seconds while maintaining gentle pressure on the crown, then flash cured using a light curing unit to remove excess cement, buccal and lingual surfaces were light cured for extra 10 seconds each.
干预措施: Bio-active cement (Drug)
Packable glass ionomer
Dentin conditioner was applied to the prepared crown surfaces for 20 sec, then rinsed, and dried. Capsule was activated, mixed for 10 seconds in an amalgamator, then loaded into the capsule applier to extrude cement directly into the crown, the crown was properly positioned over the tooth, cement was allowed to self-set for 2 minutes while maintaining gentle pressure on the crown, excess cement was removed before complete setting of cement.
干预措施: Packable glass ionomer (Drug)
结局指标
主要结局
Number of debonded crowns
时间窗: 36 months
Binary outcome (debonded/not debonded), assessed by examination
次要结局
- Number of fractured crowns(1 week, 1, 3, 6, 9, 12, 18, 24 and 36 months)
研究者
Maha Moussa Azab
Lecturer of Pediatric Dentistry, Faculty of Dentistry, Fayoum University
Fayoum University