Evaluation of Clinical Efficacy of Preformed Pediatric Zirconia Crown and Preformed Pediatric Metal Crown: A Randomized Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Comparison of clinical success
研究概览
简要总结
The study was planned to evaluate and compare the clinical success of prefabricated stainless steel crowns and zirconia crowns used in the primary molars.
The study will be carried out in healthy children aged 6-9 years with caries on more than one surface of the primary molars.
详细描述
In this study, zirconia crowns will be compared with prefabricated stainless steel crowns in a randomized controlled manner. The study will be conducted in split-mouth to eliminate the effect of potential confounders. The obtained data will be analyzed using appropriate statistical methods.
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
- 6 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy children aged 6-9 years with caries on primary molars
- •Children without systemic disease or developmental dental anomalies that may affect caries susceptibility.
- •Children whose cooperation is 'positive' or 'absolutely positive' according to the Frankl behavioral scale (Frankl et al., 1962).
- •Those with deep dentin caries that do not extend to the pulp in the teeth to be treated
- •The molars will be treated with a crown indication.
- •Presence of symmetry of the primary molar to be treated in the opposite arch.
- •The molar to be treated is in occlusion with the antagonist.
- •Presence of caries on at least two surfaces of the molars to be treated.
- •Absence of spontaneous pain, abscess, mobility, interradicular lesion in the tooth to be treated
- •Patients whose parents and themselves agree to participate in the treatment
排除标准
- •Children whose treatment cannot be continued on the dental chair due to cooperation
- •Molars that will soon be exfoliated, 1/2 of the root has been resorbed
- •The presence of bruxism
- •The presence of erosion or attrition-related wear on the opposing molar
- •The patient does not come to the control appointment or does not want to continue to the research
- •Have allergy to local anesthetic, nickel or chromium
- •Complications during treatment.
研究组 & 干预措施
Prefabricated pediatric zirconia crown group
Zirconia crowns (ZK; EZ Crowns, Spring Oral Health Technologies, Inc:, Loomis, Calif., USA).
干预措施: Prefabricated pediatric zirconia crown group (Procedure)
Prefabricated stainless steel crown group
Stainless Steel Crown (SSC, Kids Crown, Shinghung, Seoul, Korea)
干预措施: Prefabricated stainless steel crown group (Procedure)
结局指标
主要结局
Comparison of clinical success
时间窗: 24 month
According to the criteria reported by Santamaria et al. (2004), clinical success will be categorized as successful, major failure, and minor failure. Successful: * No clinical signs or symptoms of pulp pathology * Tooth has exfoliated (without any minor/major failures) * No deformations in the crown/restoration * No pathology observed in radiographs Minor failure: * Reversible pulpitis (No need for root canal treatment or extraction) * Crown/restoration loss that can be restored * Presence of deformations/fractures/perforations in the crown/restoration * Permanent crown remaining submerged * Presence of new caries at the margins Major failure: * Irreversible pulpitis * Crown/restoration loss that cannot be restored * Inter-radicular radiolucency * Internal root resorption
次要结局
- Parental satisfaction(24 month)
研究者
Haner Direskeneli
Professor
Marmara University