Longitudinal Follow-up of High Viscosity Glassionomer IonoStar Plus Versus a Composite Bulk X-tra-Fil Combined With Futurabond U (Splith Mouth Study)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Evaluation of the International Dental Federation Score
研究概览
简要总结
The main objective is the longitudinal follow-up and comparison of the maintenance of the dental filling materials up to 24 months using the HVGIC IonoStar Plus versus Bulk X-Tra -Fil composite (Futurabond U adhesive system). 150 patients will be recruited in the Mafate dental health center. Patients with minimum 2 carious lesions (or multiple of 2, maximum 6) class I or II moderate not including the cusps, and touching the outside part of the middle of dentin. Assignment period will be 4 years: Inclusion period 18 months with 2 years following (6-month, 1 year and 2 years checking) and 3 months for statistical analysis and publications process Estimation of the parameters associated with a failure of the restoration at 24 months will follow the FDI scores. The Secondary objectives are to evaluate the caries risk of isolated population thanks to Cambra application and estimate the concordance of the judgment of maintaining the restoration between the expert in-situ and experts based on the images remotely.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with 2 carious lesions (or multiple of 2) class I or II moderate not including the cusps, and touching the outside part of the middle of dentin
- •Asymptomatic tooth or with a reversible pulp syndrome tooth
- •Measured by pulp test (if not possible should not prevent the inclusion)
- •Patient consultant in investigative testing center
- •Patient of 18 to 70 years old
- •Patient able to support care
- •Patient able to understand care (no language barrier)
- •Collect the informed consent signed after a period of reflection
- •Be affiliated to a French social security scheme or recipient of such a regime
- •Tooth with criteria for pulp vitality tests of pulp sensibility
排除标准
- •Patient under guardianship
- •Pregnant or breastfeeding
- •Patient at risk for infectious endocarditis
- •Patient with severe periodontal disease (Pocket depth ≥ 5mm and/or mobility IV)
- •Patient with an allergy to one of the materials used in the study
- •Patient with an allergy to local anesthesia
- •Patient with risks of infectious endocarditis
- •Non-cooperative patient
- •Participate in another ongoing biomedical research
结局指标
主要结局
Evaluation of the International Dental Federation Score
时间窗: Change from Baseline Score FDI at 2 years
Score are numbered from 1 to 5 in ascending order of severity for aesthetic criteria (5 items), functional criteria (9 items) and biological criteria (6 items). The score will be used by the practionner making the restoration and by the remote expert to check the results and validate tele-dentistry evaluation.
次要结局
- Validation of the caries risk assememt.(Change from Baseline caries risk assement at 2 years)
- The carious presence according to the ICDAS / ICCMS criteria using the Soprolife® camera(At each follow-up visit (T0, T6 months, T1year and T2years))