A comparative evaluation of periodontal health and clinical success of prefabricated stainless steel crown, zirconia and edelweiss crowns in primary molars : A randomised clinical trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- 1.Clinical success assessment criteria for each crown as retention.
研究概览
简要总结
For children’s overall development, maintaining a healthy primary dentition is crucial. Three crucial factors are preservation of tooth structure, restorative durability, and parental satisfaction. In paediatric dentistry, several methods for full-coverage restorations have been developed.Aim is to evaluate and compare the clinical success and periodontal health of children after restoring primary molars with stainless steel crown or zirconia crown or edelweiss pediatric crown (edelweiss dentistry ®) using plaque index(PI) and gingival index(GI) and simplified oral health index(OHI -S) at one,three,six &twelve month interval.The present study is a randomised controlled clinical trial which will be conducted in the Department of Paediatric and Preventive Dentistry, Faculty of Dental Sciences, King George’s Medical University in Lucknow, Uttar Pradesh.. All patients will be selected after obtaining detailed history and thorough clinical examination. All children had at least one decayed primary molar teeth requiring full coverage restoration and an antagonist tooth and met the remaining inclusion criteria: willingness to participate in the study and to continue with the follow-up appointments.Before beginning their treatments, children, along with their parents, received a standard oral hygiene education, which consisted of a brushing demonstration by a postgraduate dental student on a model only once.Throughout the follow-ups, parents were warned when signs of gingival inflammation were present or plaque control was inadequate.The data for each tooth will be recorded on individual data record sheet. The final data will be transferred to master data sheet. The data thus obtained will be subjected to statistical analysis
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 4.00 Year(s) 至 9.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Children aged 4 to 9 years, indicated for pulpectomy followed by full coverage restoration.
- •2.Healthy cooperative children free of any systemic ailment or any developmental disturbances of the teeth and jaws that would affect patient’s diet, caries susceptibility or the selection of restorative material.
- •3.Presence of antagonist tooth, willingness to participate in the study and to continue with the follow-up appointments.
- •4.Teeth with more than two-third of the root length.
排除标准
- •1.Teeth with internal resorption 2.Teeth with physiologic root resorption more than one-third of the root length 3.Teeth that are non-restorable 4.Patients with compromised general health due to systemic disease 5.Excessive hemorrhage encountered during the clinical procedure 6.Exposures with purulent discharge or serous exudate.
结局指标
主要结局
1.Clinical success assessment criteria for each crown as retention.
时间窗: At baseline (T0) | At one month (T1) | At three month (T2) | At six month (T3) | At twelve month (T4)
2.periodontal health assessment
时间窗: At baseline (T0) | At one month (T1) | At three month (T2) | At six month (T3) | At twelve month (T4)
次要结局
- Parental Satisfaction(At baseline (T0))
研究者
Dr. Rajeev kumar singh
King Georges Medical University