Clinical Performance of Bioactive Restorative Materials in Occlusal Restorations: Preliminary Results of a Split-mouth Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- FDI-2 evaluation criteria for functional properties
研究概览
简要总结
The aim of this clinical study is to evaluate the performance of three different bioactive restorative materials against a composite resin for a period of 9 months.
This randomized, split-mouth, single-center trial was performed on patients having occlusal caries (ICDAS 3 and 4) in both molars of the same jaw. The restorative materials used were Tetric N-Ceram Bulk-fill (control, Ivoclar Vivadent, Liechtenstein), Stela (SDI, Australia), Cention Forte (Ivoclar) and Activa BioActive Restorative (Pulpdent, USA). The restorations were evaluated at baseline, 3-6 and 9-month according to FDI-2 criteria, in terms of functional, biological, and aesthetic parameters, by two experienced evaluators.
详细描述
Objectives: To clinically evaluate the performance of three different bioactive restorative materials against a composite resin for a period of 9 months.
Materials and Methods
This randomized, split-mouth, single-center trial was performed on patients having occlusal caries (ICDAS 3 and 4) in both molars of the same jaw. The restorative materials used were Tetric N-Ceram Bulk-fill (control, Ivoclar Vivadent, Liechtenstein), Stela (SDI, Australia), Cention Forte (Ivoclar) and Activa BioActive Restorative (Pulpdent, USA). The material allocation was randomly assigned by a drawing lot. The restorations were evaluated at baseline, 3-6 and 9-month according to FDI-2 criteria, in terms of functional, biological, and aesthetic parameters, by two experienced evaluators. Chi-square test was used to compare the variables in the categories. Mann-Whitney U test and paired T test compared the difference in scores for the groups (p<0.05).
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 34 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals over the age of 16 with permanent dentition
- •Individuals with a total of four vital molar teeth requiring restoration (ICDAS 3-4), two on each side of the same jaw
- •Individuals with posterior contact with antagonist teeth
- •Individuals who are reliable, cooperative, and willing to participate in periodic follow-ups
排除标准
- •Individuals whose antagonist teeth were missing or have crowns, bridges, etc.
- •Individuals with history of alcohol, drug, or medication addiction.
- •Individuals with pulp exposure during cavity preparation or a cavity depth exceeding 2-4 mm.
- •Individuals known to be unable to attend follow-up appointments.
- •Individuals with allergies to the products used in the procedure.
- •Individuals with severe tooth grinding or bruxism.
- •Individuals with caries conditions classified as ICDAS 5 and
- •Pregnant or breastfeeding individuals and individuals planning pregnancy during the study.
研究组 & 干预措施
Tetric N-Ceram BulkFill
Tetric N-Ceram Bulkfill application (control group; device 1) was randomly applied to patients.
干预措施: Tetric N Ceram Bulkfill application (Procedure)
Cention Forte
Cention Forte was randomly applied to patients.
干预措施: Cention Forte application (Procedure)
Stela Automix
Stela automix was randomly applied to patients.
干预措施: Stela Automix (Procedure)
Activa BioActive Restorative
Activa BioActive Restorative was randomly applied to patients.
干预措施: Activa BioActive Restorative (Procedure)
结局指标
主要结局
FDI-2 evaluation criteria for functional properties
时间窗: 2 years
Clinical evaluations were conducted using the FDI-2 criteria by two experienced, calibrated, and blinded evaluators for functional properties (category F). fracture/displacement of the material, marginal adaptation, form and contour, occlusion, and wear) were scored. Scores of 1-3 indicate clinically acceptable and successful restorations, score 4 indicates clinically inadequate but repairable defects, and score 5 represents clinically unacceptable restorations.
次要结局
- FDI-2 evaluation criteria for biological properties(2 years)