Clinical Performance of Glass Ionomer and Composite Restorations in First Permanent Molars Affected by Molar Incisor Hypomineralization
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Clinical Performance of Restorations Assessed Using the Modified United States Public Health Service Criteria
研究概览
简要总结
This study evaluated the clinical performances of a glass hybrid restoration and direct posterior micro-hybrid composite restorations with short fiber reinforced composite (SFRC) after Selective Caries Removal in restorations of first permanent molars (FPMs) that were affected by Molar Incisor Hypomineralization (MIH).
详细描述
This study is being carried out in the Department of Pediatric Dentistry, Dental School, Marmara University in Türkiye. The study reviewed and approved by The Human Research Ethics Committee of Marmara University, Dental School with the protocol number of 2019-355. Informed consent forms were obtained from parents or guardians before the child participated in the study.
Study design: A split-mouth, randomized, controlled clinical study was done. The children who were diagnosed with MIH on the basis of clinical examination at the Pediatric Dentistry Clinics of Dental School, Marmara University, Turkey were enrolled in the study. No children were excluded based on gender, social or economic status.
The inclusion criteria were:
- Cooperative children
- Good oral hygiene, no periodontal disease or bad habits,
- Presence of at least two permanent molars with MIH involving dentin with 31 split-mouth design study according to the clinical and radiological examination.
- Had a normal occlusal relationship with natural dentition, and had at least one adjacent tooth contact
- According to the split mouth working design, an equal number of teeth were selected from the right and left sides.
The exclusion criteria were;
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 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cooperative children.
- •Good oral hygiene, no periodontal disease or bad habits.
- •The presence of at least two permanent molars with MIH involving dentin with a split-mouth design study according to the clinical and radiological examination.
- •Had a normal occlusal relationship with natural dentition, and had at least one adjacent tooth contact.
- •According to the split mouth working design, an equal number of teeth were selected from the right and left sides.
排除标准
- •History of bruxism, known inability to return for recall appointments and allergies to ingredients of glass ionomer based restorative materials.
- •Cavity with restorations, hypoplasia, fracture or cracks, abrasion, erosion, abfraction, fistula, abscess or pathological mobility, pain, pulp exposure were excluded
结局指标
主要结局
Clinical Performance of Restorations Assessed Using the Modified United States Public Health Service Criteria
时间窗: Baseline and 12, 24, 36, and 60 months after restoration placement
The clinical performance of the restorations will be evaluated using the modified United States Public Health Service (USPHS) criteria, including retention, marginal adaptation, marginal discoloration, anatomical form, color match, secondary caries, and postoperative sensitivity. Each criterion will be rated as Alpha, Bravo, or Charlie, with Alpha indicating the best clinical outcome and Charlie indicating an unacceptable outcome or restoration failure. For most criteria, Alpha and Bravo ratings will be considered clinically satisfactory, whereas Charlie ratings will be considered clinically unsatisfactory. For secondary caries, Alpha indicates the absence of caries and Bravo indicates the presence of secondary caries.
Restoration Survival
时间窗: Baseline and 12, 24, 36, and 60 months after restoration placement
Restoration survival will be assessed at each follow-up visit (12, 24, 36, and 60 months after restoration placement) using Kaplan-Meier survival analysis. A restoration will be considered to have survived if it remains clinically functional without requiring replacement. Survival probabilities will be estimated using the Kaplan-Meier method and compared between groups using the log-rank test.
次要结局
未报告次要终点