A Randomized Multicenter Two-Arm Clinical Study to Evaluate the Safety and Efficacy of Filtek™ Bulk Fill Posterior Restorative in Class I and II Restorations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 3M
- 入组人数
- 240
- 试验地点
- 3
- 主要终点
- Clinical Acceptance Rate of Restoration at 1 Year After Replacement
研究概览
简要总结
Purpose of the Study:This study was to evaluate the 1 week, 1 year safety and effectiveness of dental composite resin (Filtek™ Bulk Fill Posterior Restorative) in restoring Class I and II dental cavities in posterior teeth.
详细描述
This was a randomized, two- arm, non-inferiority study to evaluate the safety and clinical performance of resin composite, Filtek™ Bulk Fill.
Test apparatus: Apparatus for Test: Filtek™ Bulk Fill Posterior Restorative Apparatus for Control: 3M™ ESPE™ Filtek™ Z350XT, was approved by CFDA in 2010 and had been in the market for 5 years with some validated clinical data.
Sample Size of Subjects: Two-hundred forty (240) patients were expected to be recruited into the study and were randomly assigned to the test group and the control group according to the ratio of 1: 1; thus the number of cases in each group was 120. Finally, a total of 240 subjects were randomly enrolled in the study, including 120 subjects in the test group and 120 subjects in the control group, which met the required sample size.
The study consisted of screening period (initial screening visit, post-preparation screening visit), 1-week follow-up visit and 1-year follow-up visit, during which all the tests required in the protocol would be conducted to select the subjects meeting the criteria for inclusion. The examination and evaluation of the initial screening period were supposed to be completed within 0.5 days. Then investigators would make an appointment with the subjects eligible for the initial screening for cavity preparation and tooth filling, the required time of which depended on the complexity of the tooth problem and would be completed within 0.5 days. Immediate evaluation of relevant indicators were offered to the subjects who were selected and qualified after preparation and patients with qualified score would continue to have the 1-week and 1-year follow-up visits.
Subjects were randomly assigned to either the test group (Filtek™ Bulk Fill Posterior Repository) or the control group (Filtek™ Z350XT) in a central random manner, using the corresponding test product or control product to fill and restore posterior teeth defects (class I or class II cavities).
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 (Participant, 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
- •Male or female,18 to 70 years old (including 18 and 70 years)
- •Good health, no significant systemic disease;
- •Normal opening degree;
- •Molar (preferred) or premolar teeth
- •Cavity type with belongs to any of the following： 1) Class I, including the failed class I restoration which require to be repaired.; 2) Class II, including premolar and molar except the second molar (the failed class II restoration which require to be repaired is also included), and the gingival wall of cavity is above the free gingival margin coronally; 3) Class II cavity on the second molar when the third molar exists, and the gingival wall of cavity is above the free gingival margin coronally; 4) Class II, MO or MOD cavity on the second molar when the third molar does not exist (the failed class II restoration which require to be repaired is also included), and the gingival wall of cavity is above the free gingival margin coronally;
- •Cavity size: the buccolingual diameter of cavity is no less than the 1/3 and of the buccolingual cusp distance;
- •Occlusion with natural teeth;
- •Cavity depth: no less than 1/2 of dentin with a normal pulp status;
- •Be able to understand informed consent and to provide written inform consent ;
- •Be in good compliance with the protocol and willing to return to the site for follow up visits .
排除标准
- •Allergy to multiple medicines; allergy to resin or other polymer material;
- •Acute caries, severe periodontitis, salivary glands malfunction, dysfunction/disorder of TMJ (temporomandibular joint);
- •Poor oral hygiene, DMTF:18-34y >4, 35-70y >5;
- •Teeth with abnormal staining ;
- •Pathological abrasion (e.g. bruxism, clenching), acid corrosion, cracked-teeth and other non-caries diseases.
- •Abnormal occlusion;
- •Severe systemic or mental disorders;
- •Pregnant or intended to be pregnant (pregnant test is positive ) or breast feeding women;
- •Cavity do not meet the criteria based on the investigator's judgement;
- •Resin Composite is not an appropriate restoration for the subject
- •Pulp exposure or bottom of cavity is nearly close to the pulp;
- •Subjects who is not able to return for the one year follow-up visit because of going abroad or other reasons;
- •Subject is enrolled in other studies on investigational drug or device
- •Cannot tolerate rubber dam isolation. -
结局指标
主要结局
Clinical Acceptance Rate of Restoration at 1 Year After Replacement
时间窗: 1 Year after restoration
According to Clinical Trial Guideline for Polymer-based Dental Restorative Materials (YY/T 0990-2015), the clinically acceptable definition of restoration at 1 year after replacement was as follows: The retention and fracture score of restoration at 1 year after replacement was A; the marginal fracture, the appearance and the marginal adaptationof restoration was A or B.
次要结局
未报告次要终点