Clinical Performance of Prime&Bond Active in Self-etch or Selective-etch Mode With or Without Bioglass
Randomized Blind Clinical Trial, Four-armed Parallel of Clinical Performance of Prime&Bond Active in Self-etch or Selective-etch With or Without Bioglass
Composite restoration of non-carious cervical lesions has always been a challenge for the clinician, considering that the most frequent cause of failure is retention loss.
Adhesion of composite restoration may be obtained by following four different etching techniques: total-etch in three steps, total-etch in two steps, self-etch in two steps, and self-etch in one step. Nowadays the tendency is to simplify the adhesive classic protocols. With the introduction of universal adhesives such as Prime&Bond Active (Dentsply Sirona) it is possible to obtain a total-etch pattern (enamel and dentine) without the classic etching technique with orthophosphoric acid.
On the other hand, there has been an increase in the awareness of the importance of remaining dental tissue preservation, avoiding preparation of a cavity. This is why it is now preferable to use bioactive glass in order to increase micromechanical retention on the dental surface, instead of the classical approach of preparing the surface with burs.
To date, there are no studies evaluating the clinical performance of the universal adhesive Prime&Bond Active on direct resin composite restoration of non-carious cervical lesions neither in a selective-etch mode (enamel etching) or a self-etch mode (no etching) or using sandblasting with bioactive glass. Therefore, the main objective of the study is to evaluate the retention rate of composite restorations using Prime&Bond Active and a previous sandblasted surface with bioglass in a three-year follow-up, as well as the presence of marginal discoloration, marginal integrity and marginal caries.
研究概览
地位
详细说明
The protocol to be followed in the study is as follows:
- Obtention of a written informed consent of all participants.
- Complete medical and dental clinical record.
- Administration of anesthesia and absolute rubber dam isolation.
- Cavity cleaning with a prophylactic brush and rubber cup with pumice.
Randomly assigning each non-carious cervical lesion to one of the four experimental groups:
5.1. Selective enamel etching and surface roughening with bioglass 5.2. Selective enamel etching without surface roughening. 5.3. Self-etch and surface roughening with bioglass. 5.4. Self-etch without surface roughening.
- In experimental groups which need surface roughening (group 5.1 and 5.3), sandblasting with bioactive glass will be used in enamel.
In experimental groups with selective enamel etch (5.1 and 5.2), 37 % orthophosphoric acid is applied for 15 seconds in enamel, followed by profuse washing with air/water spray for ten seconds and dried using air for 10 seconds without desiccating dentin.
In groups 5.3 and 5.4 this step is omitted.
- Application of universal adhesive Prime&Bond Active on enamel and dentin for 20 seconds. Subsequently, evaporation of the solvent is realized by applying air for 5 seconds and then light curing for 20 seconds.
- Application of a "bulk fill" composite resin and light curing, following manufacturer's instructions.
- Finishing and polishing of the restoration.
- Monitoring and follow up: visits will be performed at six months, one year, two years and three years. In each evaluation, two independent clinicians who do not participate in the clinical procedures will evaluate each direct composite restoration according to USPHS criteria (Modified United States Public Health Service).
The primary objective is to evaluate the retention of the restoration. The secondary objectives are to evaluate marginal discoloration, marginal integrity and marginal caries.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Valencia、西班牙
- University of Valencia
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients ≥ 18 years without systemic disease.
- Presence of a non-carious cervical lesion with a minimum of 1.5 mm in depth and extent to dentin.
- Non-carious cervical lesions in premolars and molars.
Exclusion Criteria:
- Presence of rampant caries or advanced periodontal disease.
- Consumption of > 2 cigarette pack/ day.
- Presence of severe xerostomia or bruxism.
- Methacrylate allergy.
- Pregnancy.
Teeth with pulpal and/or periapical pathology, and endodontically treated teeth are excluded from the study.
Teeth with previous pulp capping or previous class V restorations will also be excluded.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Selective-etch with bioglass surface roughening
|
Restoration of non-carious cervical lesions with Prime&Bond Active in self-etch or selective-etch mode with or without bioglass
|
有源比较器:Selective-etch without bioglass surface roughening
|
Restoration of non-carious cervical lesions with Prime&Bond Active in self-etch or selective-etch mode with or without bioglass
|
实验性的:Self-etch with bioglass surface roughening
|
Restoration of non-carious cervical lesions with Prime&Bond Active in self-etch or selective-etch mode with or without bioglass
|
有源比较器:Self-etch without bioglass surface roughening
|
Restoration of non-carious cervical lesions with Prime&Bond Active in self-etch or selective-etch mode with or without bioglass
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Retention rate
大体时间:Three years
|
Presence of resin composite restorations of non-carious cervical lesions at the three-year follow-up examination.
|
Three years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Marginal discoloration
大体时间:Three years
|
Presence of marginal staining between the restoration and tooth will be evaluated following USPHS criteria (Modified United States Public Health Service)
|
Three years
|
Marginal integrity
大体时间:Three years
|
The quality of the interface between restoration and tooth will be evaluated following USPHS criteria (Modified United States Public Health Service)
|
Three years
|
Marginal caries
大体时间:Three years
|
The presence of clinical diagnosis of caries will be evaluated following USPHS criteria (Modified United States Public Health Service)
|
Three years
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 2/2018
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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