Clinical Assessment of Thermo-Viscous Conventional Bulk-fill Resin Composite in Proximal Compound Posterior Restorations : A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Marginal Integrity
研究概览
简要总结
A Randomized clinical trial to evaluate the clinical assessment of thermo-viscous versus conventional bulk fill resin composite in proximal compound posterior teeth.The null hypothesis is that there is no difference between thermo-viscous and conventional bulk fill resin composite.
详细描述
Despite the improvements in resin composite materials some drawbacks still compromise the longevity of resin composite the most frequent reported limitations are related to polymerization shrinkage , to overcome these problem attempts have been made to improve the mechanical properties , the high viscosity and material stickiness as well as adaptation of the material to the walls was difficult and unpredictable .
Preheating is a method that decreases resin composite viscosity results in better adaptation and wettability of the prepared cavity walls reducing the microleakage.
A new approach based on therm-viscous technology Viscalor bulk (VOCO, Cuxhaven ) a high Viscous composite material at room and body temperature by heating to 68 C converted to flowable consistency.
Preheating composite regarding the lab research have significant clinical advantages as better adaptation reduced leakage and increase of mechanical properties .
Follow up Period will be 1 year , Evaluation will be done at baseline , after 6 months and 12 months .
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aging more than 18 years .
- •Patients with a high level of oral hygiene.
- •Patients having at least 12 posterior teeth in occlusion.
- •Patients with good likelihood of recall availability.
- •Tooth Inclusion :
- •Permanent premolars and molars.
- •Moderate to deep compound class II cavities.
- •well formed fully erupted .
- •Vital with positive reaction to cold and hot stimulus.
排除标准
- •Participants with general systematic illness.
- •Pregnant or lactating females.
- •Concomitant participation in another research study.
- •Inability to comply with study procedures.
- •Heavy Bruxism habits.
- •Patients receiving Orthodontic treatment.
- •last experience with allergic reactions against any component of used materials .
- •Tooth exclusion :
- •Non vital teeth.
- •Secondary carious lesions.
- •Teeth with clinical symptoms of pulpitis such as spontaneous pain or sensitivity to pressure.
结局指标
主要结局
Marginal Integrity
时间窗: 1 year
Modified US Public Health Service Criteria (USPHS)
次要结局
- Clinical Evaluation of restoration ( Marginal discoloration,secondary caries and Postoperative Sensitivity )(1 year)
研究者
Yasmin Atef Ahmed Ibrahim
Assistant Lecturer
Cairo University