Comparative Assessment of Bioflx crown, Composite crown and Stainless steel crown in patient having Molar incisor hypomineralisation: A Randomised Clinical Study.
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 发起方
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Clinical performance of crowns using the Modified United States Public Health Service (USPHS) Criteria
研究概览
简要总结
This study is a randomized clinical trial designed to compare the clinical performance and patient satisfaction of three different types of dental crowns—Stainless Steel Crown (SSC), Composite Crown, and Bioflx Crown—in children aged 7 to 14 years with Molar-Incisor Hypomineralisation (MIH). A total of 57 teeth will be randomly assigned into three groups. Clinical success will be evaluated using Modified United States Public Health Service (USPHS) criteria, and satisfaction will be assessed through structured questionnaires for parents and children using a 5-point Likert scale. Follow-up evaluations will be conducted at 6, 12, and 24 months post-treatment to determine which crown provides the best outcome in terms of durability, functionality, and esthetics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 7.00 Year(s) 至 14.00 Year(s)（—）
- 性别
- All
入选标准
- •Children between 7 to 14 years having permanent molars diagnosed with MIH-TNI20 score 2 (MIH with enamel breakdown but without hypersensitivity) & Score 4 (MIH with enamel breakdown and with hypersensitivity)
- •Normal and healthy Co-operative participants.
- •Parents/Guardian who are willing to give a written informed consent and assent by participants will be included in the study.
排除标准
- •A pathological discrepancy of root resorption
- •Inflammation at the furcation area
- •Permanent teeth having not sufficient crown structure
- •Teeth with root caries
- •Mentally challenged or disabled childrens and children with any type of dentofacial abnormality will be excluded from the study.
结局指标
主要结局
Clinical performance of crowns using the Modified United States Public Health Service (USPHS) Criteria
时间窗: baseline, 6 months, 12 months, 24 months
次要结局
- To assess and compare the satisfaction levels of parents and children regarding Stainless Steel Crowns, Composite Crowns, and Bioflx Crowns placed on permanent molars affected by MIH.
研究者
Dr Anshula Deshpande
K.M Shah Dental college & Hospital, Sumandeep Vidyapeeth, Deemed to be University