Clinical Evaluation of Different Bioactive Restorative Materials for Cervical Carious in High Caries Risk Patients :A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- clinical performance (Post operative hyper sensitivity)
研究概览
简要总结
The aim of the study is to clinically evaluate three different bioactive restorative material in cervical carious lesion in high caries risk patients.
Reducing the incidence of recurrent caries is the primary outcome
详细描述
Bioactive restorative materials are relatively new concept in dentistry combines between esthetics, strength and resilience of composites with bioactive properties, the development of therapeutic bio-interactive materials results in tissue re-mineralization, reduces the susceptibility to tooth mineral loss, and recovers its mechanical properties .
Patients, with high caries, have many risk factors like inadequate biofilm control, salivary flow deficiency, and altered host defense. Conventional restorative materials expose the tooth structure to stress concentration. Moreover, preserving the tooth restoration interface intact is great challenge to avoid recurrent caries, which may also result in restoration failures .
This prospective study will be investigating and comparing the eighteen month clinical performance of a different bioactive restorative materials and a conventional Pre-reacted glass ionomer restorative material in class V cavity preparation.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Double ( participant, Outcome Assessor)
入排标准
- 年龄范围
- 25 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient age range from 25-45 year.
- •High risk caries.
- •Patients required at least a couple of Class V restorations.
- •The depth of lesion should be(1.5- 2 mm) .
- •The patient should have good general health
排除标准
- •Poor oral hygiene.
- •Sever or chronic periodontal disease or Bruxism.
- •Severe tooth sensitivity.
- •Non-vital or fracture or cracked teeth.
- •Defective restorations, orthodontic treatment or bleaching procedures during the last 6 months.
- •pregnancy, and/or lactation, and allergy to the main components of the products to be used in the study
结局指标
主要结局
clinical performance (Post operative hyper sensitivity)
时间窗: 12 months
method of measurement is Modified United State Public Health Service Criteria (Modified USPHS) using Binary (yes/ no) yes outcome mean recurrent caries present, no mean no recurrent caries present .
次要结局
- clinical performance (Fracture and retention, marginal integrity, marginal discoloration, anatomic form, surface texture, postoperative sensitivity)(18 months)
研究者
Yehia Hafez Yehia
Lecturer of Conservative Dentistry Department
Cairo University