Clinical Performance of a One-step Self-etch Adhesive in Non-carious Cervical Lesions at 2 Years
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Recurrent caries during examination
研究概览
简要总结
Objectives: One-step self-etch adhesives are the latest adhesives introduced into the market. The aim of this randomized controlled clinical trial was to test the hypothesis that a one-step self-etch adhesive performs equally well as a two-step etch-and-rinse adhesive.
Materials and methods: Thirty two patients with 96 non-carious cervical lesions received composite-resin restorations (Tetric Evo Ceram - Ivoclar/Vivadent), which were bonded either with a one-step self-etch adhesive (AdheSE One - Ivoclar/Vivadent) with or without enamel etching, or with a two-step etch-and-rinse adhesive (ExiTE - Ivoclar/Vivadent). All restorations were evaluated by two examiners at baseline, 6, 12, 18 and 24 months regarding retention, caries recurrence, marginal integrity and discoloration. Retention loss, severe marginal defects and/or discoloration that needed intervention (repair or replacement) and occurrence of caries, were considered as clinical failures. A logistic regression analysis with generalized estimating equations was used to account for the clustered data (three restorations per patient).
详细描述
Sample selection Patients, receiving dental treatment in the Clinic of Restorative Dentistry, constituted the selection pool. Written informed consent was obtained from all participants before starting treatment. A total of 32 participants were examined to check if they met the inclusion and exclusion criteria by two precalibrated operative dentistry residents. The qualified patients were recruited in the order in which they reported for the screening session, thus forming a convenience sample.
Patients, irrespective of age and gender, should have at least three non-carious cervical lesions on incisors, canines and premolars of the upper or lower jaw. Each lesion should be located at the cervical third of the buccal side of the tooth, be either at the same level or above the gums, have its cervical wall on dentin, not extend on adjacent surfaces and not exceed 5mm in length, 3mm in height and 1.5mm in depth.
Patients receiving periodontal therapy, presenting high caries activity or TMJ problems needing treatment with mouthguards, were excluded from the study.
A total of thirty two patients with ninety six lesions, were eventually included in the study.
Restoration process
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 (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least three non-carious cervical lesions on incisors, canines and premolars of the upper or lower jaw. Each lesion should be located at the cervical third of the buccal side of the tooth, be either at the same level or above the gums, have its cervical wall on dentin, not extend on adjacent surfaces and not exceed 5mm in length, 3mm in height and 1.5mm in depth
排除标准
- •Patients receiving periodontal therapy, presenting high caries activity or TMJ problems needing treatment with mouthguards, were excluded from the study.
结局指标
主要结局
Recurrent caries during examination
时间窗: 2 years
percentage of lesion with recurrent caries
Marginal discolouration of the restorations
时间窗: 2 years
percentage of stained lesions
Retention of the restorations
时间窗: 2 years
percentage of retained restorations
Marginal adaptation of the restorations
时间窗: 2 years
Measured in μm
次要结局
未报告次要终点
研究者
Effie Pappa
Dr
University of Athens