Clinical Evaluation of the Effect of Wet and Overwet Dentin Using Two Universal Adhesives in Restorations of Non-carious Cervical Lesions: Double Blind Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Retention of restorations
研究概览
简要总结
The aim of this study will be to evaluate the effect of wet and overwet dentin on the long-term clinical performance of two universal adhesive systems used as etch-and-rinse application mode in non-carious cervical lesions (NCCLs).
Materials & Methods: 200 restorations will be randomly placed in 50 subjects according to the following groups (n=50): AMP-wet (Ambar Universal APS Plus adhesive on wet dentin); AMP-overwet (Ambar Universal APS Plus adhesive on oversaturated dentin); PBA-wet (Prime&Bond Active adhesive on wet dentin); PBA-overwet (Prime&Bond Active adhesive on oversaturated dentin). For all groups, the enamel and dentin will be etched for 15s. All groups will be light-cured for 10s/1,000 mW/cm2. A resin composite will be placed by applying three increments and each one was light cured for 20s/1,000 mW/cm2. The restorations will be finished immediately with fine diamond burs and spiral polishers. The restorations will be evaluated at baseline and after 6 months by using the FDI criteria. The following outcomes will be evaluated: retention, marginal staining, marginal adaptation, post-operative sensitivity and recurrence of caries. The differences among the groups will be calculated using Friedman repeated measures analysis of variance rank (α = 0.05).
详细描述
This is a four-arm, double-blind, randomized controlled clinical trial.
Control group 1: 50 non-carious cervical lesions (NCCL) will receive composite resin restorations using an universal adhesive (Ambar Universal APS Plus; FGM) on wet dentin in the etch-and-rinse application strategy.
Control group 2: 50 non-carious cervical lesions (NCCL) will receive composite resin restorations using an universal adhesive (Prime&Bond Active; Dentsply Sirona) on wet dentin in the etch-and-rinse application strategy.
Experimental group 1: 50 non-carious cervical lesions (NCCL) will receive composite resin restorations using an universal adhesive (Ambar Universal APS Plus; FGM) on overwet dentin in the etch-and-rinse application strategy.
Experimental group 2: 50 non-carious cervical lesions (NCCL) will receive composite resin restorations using an universal adhesive (Prime&Bond Active; Dentsply Sirona) on overwet dentin in the etch-and-rinse application strategy
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)
盲法说明
Two blinded, experienced, and calibrated dentists (who specialized in esthetic dentistry with more than 15 years of clinical practice), will perform the clinical evaluation. Patients will be also blinded to group assignment. An inter-examiner and inter-examiner agreement of at least 85% will be necessary before beginning the evaluation
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients older than 18 years.
- •Presence of at least two Non-Carious Cervical Lesions in the dental arch with a need for restorative treatment.
- •Acceptable level of oral hygiene according to the Simplified Oral Hygiene Index.
- •At least 20 teeth in function.
排除标准
- •Driving difficulties that prevent adequate oral hygiene.
- •Periodontal disease.
- •Active caries lesions on the teeth included in the research.
- •Parafunctional habits.
- •Active staples of removable partial dentures on the teeth included in the research and that these are not pillars of prostheses.
研究组 & 干预措施
Experimental group 1
50 non-carious cervical lesions (NCCL) will receive composite resin restorations in the etch-and-rinse strategy.
干预措施: Dentin Overwet (Procedure)
Experimental group 1
50 non-carious cervical lesions (NCCL) will receive composite resin restorations in the etch-and-rinse strategy.
干预措施: Ambar Universal APS Plus; FGM (Device)
Experimental group 2
50 non-carious cervical lesions (NCCL) will receive composite resin restorations in the etch-and-rinse strategy.
干预措施: Dentin Overwet (Procedure)
Experimental group 2
50 non-carious cervical lesions (NCCL) will receive composite resin restorations in the etch-and-rinse strategy.
干预措施: Prime&Bond Active; Dentsply Sirona (Device)
Control group 1
50 non-carious cervical lesions (NCCL) will receive composite resin restorations in the etch-and-rinse strategy.
干预措施: Dentin Wet (Procedure)
Control group 1
50 non-carious cervical lesions (NCCL) will receive composite resin restorations in the etch-and-rinse strategy.
干预措施: Ambar Universal APS Plus; FGM (Device)
Control group 2
50 non-carious cervical lesions (NCCL) will receive composite resin restorations in the etch-and-rinse strategy.
干预措施: Dentin Wet (Procedure)
Control group 2
50 non-carious cervical lesions (NCCL) will receive composite resin restorations in the etch-and-rinse strategy.
干预措施: Prime&Bond Active; Dentsply Sirona (Device)
结局指标
主要结局
Retention of restorations
时间窗: From date of randomization until thirty-six four months
Retention measured by World Dental Federation (FDI) criteria as following: * VG: Clinically very good - Restoration retained, no fractures / cracks; * G: Clinically good - Small hairline crack; * SS: Clinically sufficient/satisfactory - Two or more or larger hairline cracks and/or chipping (not affecting the marginal integrity); * US: Clinically unsatisfactory - Chipping fractures which damage marginal quality; bulk fractures with or without partial loss (less than half of the restoration); * PO: Clinically poor - (Partial or complete) loss of restoration, (replacement necessary).
次要结局
- Marginal Adaptation of restorations(From date of randomization until thirty six months)
- Marginal Staining of restorations(From date of randomization until thirty six months)
研究者
Mario Felipe Gutiérrez Reyes
Associate Professor
Universidad de los Andes, Chile