Clinical Evaluation of a Universal Adhesive in Noncarious Cervical Lesions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Retention of Restorations
研究概览
简要总结
The purpose of this prospective clinical trial will be to evaluate the efficacy of an FDA approved and marketed universal dental adhesive formulation in adult noncarious cervical lesions using self-etch and selective etch approaches.
The hypothesis is that using a selective enamel etch with this universal adhesive will enhance the restoration margin performance.
详细描述
The purpose of this prospective clinical trial will be to evaluate the efficacy of a newly formulated universal dental adhesive formulation in adult noncarious cervical lesions using self-etch and selective etch approaches.
Thirty-three patients with at least two non-carious cervical lesions will receive one restoration utilizing the self-etch universal adhesive with no separate enamel etching and another restoration utilizing the universal adhesive and a a selective etch protocol in which in which enamel is etched with 37% phosphoric acid.
After a screening/baseline visit at which the restorative procedures listed above will conducted, the patient will be seen at recall visits after approximately 6, 12 and 24 months to observe sensitivity, retention, marginal discoloration and marginal adaptation.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria
- •Willing to provide written consent and authorization for participation.
- •Be between 20 and 75 years of age at the time of recruitment
- •Have at least two non-carious cervical lesions present in canine or premolar teeth;
- •Anticipates availability for recalls (roughly 6 month, 12 month, and 24 month) through the two-year study period
- •The lesions selected will be at least 1 mm in depth (measured with a perio probe) and contain both enamel and dentin margins.
排除标准
- •Exclusion criteria
- •Severe medical complications (organ transplants, cancer, immunocompromised, long term antibiotic or steroid therapy);
- •Active caries on study teeth;
- •Bleeding on probing of study teeth;
- •Generalized severe periodontitis;
- •Patient reported symptoms (burning mouth, loss or diminished taste, saliva amount too little, needs liquids to eat dry foods) or clinical signs (erythematous tongue, chelitis, lack of pooled saliva) associated with dry mouth;
- •Patients determined to be at a high risk of caries as determined by a Caries Risk Assessment
研究组 & 干预措施
Adhese Universal with self etch enamel etching
patients will receive one restoration on randomly selected study tooth utilizing the self-etch universal adhesive (Adhese Universal, Ivoclar Vivadent) with no separate enamel etching
干预措施: Self etch enamel etching (Procedure)
Adhese Universal with self etch enamel etching
patients will receive one restoration on randomly selected study tooth utilizing the self-etch universal adhesive (Adhese Universal, Ivoclar Vivadent) with no separate enamel etching
干预措施: selective etch protocol (Procedure)
Adhese Universal with self etch enamel etching
patients will receive one restoration on randomly selected study tooth utilizing the self-etch universal adhesive (Adhese Universal, Ivoclar Vivadent) with no separate enamel etching
干预措施: Adhese Universal (Device)
selective etch protocol followed by Adhese Universal
patients will receive one restoration on randomly selected study tooth utilizing a 37% phosphoric acid solution followed by application of self-etch universal adhesive (Adhese Universal, Ivoclar Vivadent)
干预措施: Self etch enamel etching (Procedure)
selective etch protocol followed by Adhese Universal
patients will receive one restoration on randomly selected study tooth utilizing a 37% phosphoric acid solution followed by application of self-etch universal adhesive (Adhese Universal, Ivoclar Vivadent)
干预措施: selective etch protocol (Procedure)
selective etch protocol followed by Adhese Universal
patients will receive one restoration on randomly selected study tooth utilizing a 37% phosphoric acid solution followed by application of self-etch universal adhesive (Adhese Universal, Ivoclar Vivadent)
干预措施: Adhese Universal (Device)
结局指标
主要结局
Retention of Restorations
时间窗: 6, 12, 24 months
The primary outcome measure will be restoration retention. In these non-retentive dental lesions, the adhesive will be the only mode of retention. Failure of the adhesive would result in loss of the restoration.
次要结局
- Number of Restoration Margins Marked as Stained or Discolored(6, 12, 24 months)
研究者
Jeffrey A. Platt
Associate Professor of Dental Materials
Indiana University