A randomized controlled trial to evaluate the performance of posterior Class I restorations using fluoride-releasing dental restoratives and bulk fill composite resin in an Indian population: A double-blind split-mouth study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The clinical performance of the restorations evaluated using the modified USPHS criteria (including parameters such as marginal integrity, surface texture, color match, and secondary caries).
研究概览
简要总结
The primary purpose of this protocol is to evaluate and compare the clinical performance of three fluoride-releasing restorative materials (Zirconomer, Cention N, and Beautifil Bulk Restorative) with a bulk-fill composite resin (Filtek One Bulk-fill) in Class I occlusal restorations of permanent molars over a 24-month period in an Indian population. The study aims to assess the restorations using revised FDI criteria, focusing on aesthetic, functional, and biological outcomes.
Null hypothesis:
There is no difference in the performance of posterior Class I restorations with Fluoride-releasing dental restoratives (Zirconomer, Cention N, and Beautifil Bulk Restorative) and Bulk-fill composite resin (Filtek One Bulk-fill) in an Indian Population.
Alternate hypothesis:
There is a difference in the performance of posterior Class I restorations with Fluoride-releasing dental restoratives (Zirconomer, Cention N, and Beautifil Bulk Restorative) and Bulk-fill composite resin (Filtek One Bulk-fill) in an Indian Population.
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
- 19.00 Year(s) 至 53.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with with at least four single-surface occlusal caries on their posterior teeth.
- •Patients diagnosed with at least four ICDAS code 4–5 carious lesions (Class I) in Mature Permanent Molar teeth.
- •Single surface-occlusal caries restricted to fissures and do not involve cusps that are vital and without pulpal or periodontal disease, pain, and preoperative sensitivity; should be in occlusion with opposing natural teeth.
- •Patients willing to come to follow-up appointments.
排除标准
- •Morbid Individuals with Systemic Diseases.
- •Decay involving Cusp, grossly carious teeth.
- •Partially erupted teeth.
- •Absence of antagonist teeth.
- •Teeth with interproximal caries.
结局指标
主要结局
The clinical performance of the restorations evaluated using the modified USPHS criteria (including parameters such as marginal integrity, surface texture, color match, and secondary caries).
时间窗: The restorations will be assessed at: | Baseline (immediately after placement), | 4 weeks, and | 8 weeks. | These time intervals will help determine both short-term performance and early clinical behavior of the materials.
次要结局
未报告次要终点
研究者
Ameya Mahavir Lokhande
TPCTs Terna Dental College