Comparative evaluation of child-parental satisfaction and radiographic analysis of Bioflex, Zirconia and Stainless steel crowns in pediatric patients.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- The study will help us to know which crown among the Bioflex , Zirconia and Stainless steel is better in terms of Clinical(GI & PI) , Radiographic (marginal adaptation) and child-parental satisfaction(MCDAS & likert scale).
研究概览
简要总结
54 samples will be collected and divided into Three groups each of n=18 namely :-
Group 1 – Patients with Bioflex Crowns as restoration.
Group 2 - Patients with Zirconia Crowns as restoration.
Group 3 - Patients with Stainless Steel Crowns as restoration.
54 Patients will be selected based on the Inclusion and Exclusion Criteria. Complete process of what process will going to perform on the tooth of the child will be explained to the Parents/The person accompanying the patient. All the procedures will going to be performed under rubber dam isolation. The Radiovisiography(RVG) radiographs will be taken. The crown to be prepared and patients will be divided into selected groups. The placement of Bioflex, Zirconia and Stainless Steel Crowns will be done. All the crowns will be placed by a single operator.
Local anesthesia will be administered and rubber dam will be placed. The manufacturer’s guidelines will be followed to develop a step by step customized tooth preparation to ensure all crowns were fitted in a similar manner. All crowns will be luted using type I Glass Ionomer Cement. The type and size of crown chosen as well any adaption methods done for each molar were recorded. Patients will be given postoperative instructions. Participants will recalled for follow up at 3 months, 6 months, 12 months. Variables for the clinicians satisfaction will be scored using a customized scoring table which was modified from similar previous studies.
Immediate post cementation radiograph will be taken for baseline measurements. Patient will then be recalled after 3, 6 and 12 months. The recalled patients will be checked for “plaque accumulation and gingival health†by using Plaque Index and Gingival Index, respectively. And the “Marginal Adaptation†will be checked by using Radiovisiography(RVG).
Child satisfaction is determined using Modified Child Dental Anxiety Scale(MCDAS). Parental satisfaction was assessed on a Likert type scale from 1 to 5. The questionnaire will be given to parents. Parents will asked to return the questionnaire on completion. Scores 1 and 2 were combined as satisfied, score 3 as neutral response and scores 4 and 5 were combined as dissatisfied. Scoring of parental and child satisfaction will be taken at 3 months, 6 months, 12 months .Then the respective outcomes will be compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 5.00 Year(s) 至 10.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients within the age group of 5-10 years.
- •2.Healthy children free of any systemic disease.
- •3.Deciduous teeth having two-thirds of root structure left radiographically.
- •4.Presence of one-third of crown shape.
- •5.Children free of any developmental disturbances of the teeth.
- •6.Asymptomatic primary molars following pulp therapy indicated for full coverage restoration.
- •7.Patients with good oral hygiene.
- •8.Children with signed consent form by the parent or guardian after being informed about the various benefits, risks and treatment outcomes.
排除标准
- •1.Teeth exhibiting Pre-shedding mobility.
- •2.Children with parafunctional habits.
- •3.A pathological discrepancy of root resorption.
- •4.Inflammation at the furcation area.
- •5.Deciduous teeth having not sufficient crown structure.
- •6.Teeth with root caries.
结局指标
主要结局
The study will help us to know which crown among the Bioflex , Zirconia and Stainless steel is better in terms of Clinical(GI & PI) , Radiographic (marginal adaptation) and child-parental satisfaction(MCDAS & likert scale).
时间窗: 12 Months
次要结局
- Best effective crown material among Bioflex , Zirconia and Stainless Steel is been evaluated , which will be helpful in future restorative treatments in Pediatric patients.(12 Months)
研究者
Dr Namrata Ingavale
Government Dental College, Raipur.