A One Year Comparative Evaluation Of Clinical Performance Of Activaâ„¢ Bioactive Composite With Microhybrid Composite In Abfraction Lesions: A Randomized Control Study
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Two blinded examiners will evaluate the restorations with a mouth mirror and probe at baseline, 1 month, 6 months, and 1 year by modified USPHS criteria which involves Retention, Color Match, Marginal Discoloration, Marginal Adaptation, Secondary Caries, Surface Texture, Anatomic Form, Postoperative Sensitivity and also occlusal interferences will be evaluated using Shim Stock films.
研究概览
简要总结
The study is a randomized controlled clinical trial. Verbal and written consent will be obtained from the patients fulfilling the inclusion and exclusion criteria after briefing them about the procedure. Randomization will be done using computer generated tabulation method into
Group1 control n 17 Filtek Z250 microhybrid composite restoration
Group2 experimental n 17 Activa**â„¢**bioactive composite restoration based on the inclusion and exclusion criteria
Clinical procedure
Patients who will be selected for this study will be first evaluated for occlusal contacts.The patients who require occlusal corrections will undergo complete occlusal adjustments via selective grinding prior to restoration. After occlusal adjustments are done the same researcher will perform all restorative procedures. For standardization purposes all restorations will be carried out with rubber dam isolation and cleaning of the walls of the tooth to be restored with pumice paste and water. Cavities will be prepared by rounding the internal angles in order to reduce internal stress and all sharp line angles will be smoothened and beveled with a fine bur.
Restorative procedure
The composite placement will be done according to the manufacturers recommendations .The restorations will be finished and polished using supersnap kit
Clinical evaluation
Two blinded examiners will evaluate the restorations with a mouth mirror and probe at baseline, 1 month, 6 months, and 1 year by modified USPHS criteria which involves retention, color match, marginal discoloration, marginal adaptation, secondary caries, surface texture, anatomic Form, postoperative sensitivity and also occlusal interferences will be evaluated using shim stock films
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients having isolated abfraction lesions with more than 1 mm depth on the vestibular sides, associated with premolars and molars caused due to abnormal biomechanical loading forces will be selected for the study.
排除标准
- •Poor oral hygiene Severe or chronic periodontitis Patients with severe occlusal problems and parafunctional habits Patients with temporo mandibular joint disorders Patients who give signs and symptoms of irreversible pulpitis A known allergic reaction to any of the components of the materials used, Non-vital, fractured or visibly cracked tooth Cervical caries.
结局指标
主要结局
Two blinded examiners will evaluate the restorations with a mouth mirror and probe at baseline, 1 month, 6 months, and 1 year by modified USPHS criteria which involves Retention, Color Match, Marginal Discoloration, Marginal Adaptation, Secondary Caries, Surface Texture, Anatomic Form, Postoperative Sensitivity and also occlusal interferences will be evaluated using Shim Stock films.
时间窗: Two blinded examiners will evaluate the restorations at baseline, 1 month, 6 months, and 1 year by modified USPHS criteria
Comparative evaluation of clinical performance of both the composites using modified USPHS criteria
时间窗: Two blinded examiners will evaluate the restorations at baseline, 1 month, 6 months, and 1 year by modified USPHS criteria
次要结局
- Patients satisfaction and(satisfactory clinical performance of restorative material in abfraction lesions)