Clinical Performance of Sonic-Activated High Viscosity Bulk-Fill Resin Composite in Comparison to Conventional Bulk-Fill Resin Composite Restorations in Posterior Teeth: A Randomized Controlled Clinical Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- change in clinical performance
研究概览
简要总结
The present study aims to evaluate a 2-years clinical performance of sonic-activated bulk-fill resin composite material (sonic fill) in comparison to conventional bulk-fill resin composite (X-tra fill) as posterior restorations. The null hypothesis is that sonic-activated bulk-fill resin composite restoration shows no difference when compared to conventional bulk-fill resin composite in clinical performance over 2-years evaluations based on clinical assessment.
详细描述
Restorations will be evaluated 1 week after placement (Baseline - T0), 3 months (T1), 6 months (T2), 1-year (T3) and 2-years (T4) of clinical service by blinded calibrated examiner using modified United States Public Health Service (USPHS) criteria where score A (Alpha) stands for the clinically ideal restoration. Score B (Bravo) is a clinically acceptable situation except for secondary caries. Score C (Charlie) indicates clinically unacceptable restorations that must be replaced.
The restorations will also be evaluated using revised FDI criteria with five grades for each criterion; scores 1 to 3 indicated clinically acceptable restorations, and scores 4 and 5 summarized clinically unacceptable situations indicating repair (score 4) or replacement (score 5).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •They should have an acceptable oral hygiene level.
- •Presence of at least two posterior carious lesions to be restored with two different types of composite.
- •The two materials should be used in approximately the same sized lesions or within the same extension.
- •Age range between 18 and 45 years.
- •A good likelihood of recall availability.
排除标准
- •Severe or active periodontal or carious disease.
- •Heavy bruxism or a traumatic occlusion.
- •Patients with a compromised medical history or had received therapeutic irradiation to the head and neck region.
- •Alcoholic and smoker patients.
- •Patients had participated in a clinical trial within 6 months before commencement of this trial.
- •Patients unable to return for recall appointment.
结局指标
主要结局
change in clinical performance
时间窗: 1 week, 3 months, 6 months, 12 months
restorations' evaluation for retention, color matching, marginal discoloration, marginal adaptation, secondary caries, surface texture, anatomic form. Score A (Alpha) stands for the clinically ideal restoration. Score B (Bravo) is a clinically acceptable situation except for secondary caries. Score C (Charlie) indicates clinically unacceptable restorations that must be replaced. Also will be scored from 1 to 5 , which 1 to 3 indicated clinically acceptable restorations, and scores 4 and 5 summarized clinically unacceptable situations indicating repair (score 4) or replacement (score 5).
次要结局
- change in post-operative pain using modified Visual Analogue Scale (VAS)(daily for 1 week)
研究者
Ashraf Aref
PhD candidate
Minia University