Comparative Evaluation of clinical performance of two methods of Stainless Steel Crown placement ; Modified Hall vs Conventional in molars affected with Molar Incisor Hypomineralization: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Time taken for placement of Stainless steel crown in both the groups
研究概览
简要总结
This randomized clinical trial aims to compare the clinical performance of two methods of stainless steel crown (SSC) placement - the Modified Hall technique and the Conventional technique in permanent molars affected by Molar–Incisor Hypomineralization (MIH) in children. A total of 30 MIH affected molars will be randomly allocated into two groups using variable permuted block randomization. Group I will receive SSCs using the Modified Hall technique, and Group II will receive SSCs using the Conventional technique. All procedures will be performed under standardized clinical protocols. Follow-up assessments will be conducted at baseline, immediately post-operative, 1 month, 3 months and 6 months. Clinical outcomes such as crown retention, marginal integrity, proximal contact , gingival health, and occlusal settling will be evaluated. The study seeks to determine whether the minimally invasive Modified Hall technique can achieve clinical performance comparable or superior to the Conventional method thereby supporting a less invasive and more child-friendly restorative approach for MIH-affected molars.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 7.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Molar Incisor Hypomineralization (MIH) affected first permanent molar showing hypersensitivity, post eruptive enamel breakdown, atypical carious lesion, or unsatisfactory atypical restoration clinically indicated for full coverage restoration Teeth with two or more surfaces involved, no clinical or radiographic signs of pulpal involvement, and remaining dentin thickness more than 2 mm Children demonstrating positive or definitely positive behaviour as per the Frankl Behaviour Rating Scale.
排除标准
- •MIH affected molars with small, localized defects that can be managed using direct restorative procedures Children presenting with developmental enamel defects other than MIH, such as amelogenesis imperfecta or severe fluorosis Medically compromised children or those with systemic illnesses Teeth indicated for root canal treatment or showing pulpal involvement Children or parents unwilling to provide consent or refusing to participate in the study.
结局指标
主要结局
Time taken for placement of Stainless steel crown in both the groups
时间窗: Baseline (Pre-operative), Immediate Post-operative, 1 month,3 months and 6 months
Patient comfort using Visual analogue scale in both the groups
时间窗: Baseline (Pre-operative), Immediate Post-operative, 1 month,3 months and 6 months
Retention of crown using Modified USPHS criteria over 6 months in both the study groups
时间窗: Baseline (Pre-operative), Immediate Post-operative, 1 month,3 months and 6 months
次要结局
- Changes in marginal adaptation and proximal contact using Modified USPHS 2005 criteria(Immediate Post-operative, 1 month,3 months and 6 months)
- Changes in overbite and occlusal proximity using intraoral scanner and Dexis IS Scanflow software(Baseline (Pre-operative), Immediate Post-operative, 1 month,3 months)
- Periodontal health measurement using silness and loe Plaque Index and Loe and Silness Gingival Index(Baseline (Pre-operative), Immediate Post-operative, 1 month,3 months and 6 months)
- TMJ dysfunction using Helkimo index(Baseline (Pre-operative), Immediate Post-operative, 1 month,3 months and 6 months)
- Radiographic changes including crown margins and root development(Baseline (Pre-operative), Immediate Post-operative and 6 months)
研究者
Dr Sumedha Gupta
Post Graduate Institute of Medical Education and Research, Chandigarh