Clinical and Radiographical Evaluation of New Bioactive Dentine Substitute (Biodentine) Versus Glass Ionomer Cement in Treatment of Very Deep Carious Lesions -Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- postoperative hypersensitivity using yes or no questionnaire
研究概览
简要总结
The aim of this study is to compare the effect of new bioactive dentine substitute (Biodentine) versus glass ionomer cement in very deep carious lesions clinically and radiographically using digital radiography in the terms of postoperative pain and biocompatibility to the pulp.
详细描述
Roles and responsibilities:
- Omnia Magdy Moustafa (O.M.) Operator, data entry & corresponding author; Assistant lecturer ,
- Mohmed Riad Farid (M.R.) Main supervisor, data monitoring & auditing; Professor, Conservative Dentistry
- Rasha Raffat (R.R.) Co-supervisor, data entry & auditing; Lecturer, Conservative Dentistry Department
- Amir Hafez Ibrahim (A.H.), *Mohamed Refaat El-Bialy (M.E.) (A.H) Lecturer, Conservative Dentistry Department, Faculty of Oral & Dental Medicine Cairo University,(M.E.) Assistant lecturer , Conservative Dentistry Department, Faculty of Oral & Dental Medicine Cairo University outcome assessors and data collection.
- Omar Shalaan (O.S.) Demonstrator, Conservative Dentistry Department, Faculty of Oral & Dental Medicine Cairo University, for baseline data collection, recruitment, sequence generation, allocation concealment, patient retention and taking participants consents.
Interventions:
- Pre-operative clinical assessment :
- Thermal testing using Refrigerant spray
- percussion test
- Palpation and clinical examination
- peri-apical radiographs using digital radiograph
- Caries removal procedure:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients male or female older than 18 y in good general health
- •A minimum of 1 deep carious lesion penetrating three-quarters or more into the dentine as identified with the periapical (PA) radiograph; Clinically according to International Caries Detection and Assessment System (ICDAS II) score 4
- •Clinical symptoms of reversible pulpitis
- •Positive pulp response to electric pulp test or thermal stimulation
- •No PA changes viewed on PA radiograph
排除标准
- •Clinical symptoms of irreversible pulpitis requiring endodontic treatment
- •Presence of fistulas or swelling
- •Mobile teeth or tenderness to percussion
- •Anterior teeth with aesthetic concerns
- •Pregnant women, in view of requirements for radiographs
- •Patients younger than 18 y
- •Patients unable to give consent
研究组 & 干预措施
biodentine
bioactive dentin substitute used to act like natural dentin in insulating the pulp against external stimuli intervention
干预措施: biodentine (Drug)
biodentine
bioactive dentin substitute used to act like natural dentin in insulating the pulp against external stimuli intervention
干预措施: DigoraH optium (Device)
glass ionomer cement
high viscosity glass ionomer used as a base material comparator other name : - fuji ix
干预措施: glass ionomer cement (Drug)
glass ionomer cement
high viscosity glass ionomer used as a base material comparator other name : - fuji ix
干预措施: DigoraH optium (Device)
结局指标
主要结局
postoperative hypersensitivity using yes or no questionnaire
时间窗: 6 months
次要结局
- Biocompatibility of biodentine using digital X-ray(6 months)
研究者
Omnia Magdy Moustafa
Assistant lecturer , Conservative Dentistry Department, Faculty of Oral & Dental Medicine Cairo University
Cairo University