Chlorhexidine as Coadjuvant in Dentin Adhesion of Noncarious Cervical Lesions and Failure-prognostic Variables: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change from baseline in Retention rates of the restoration at 24 months
研究概览
简要总结
This study aims to evaluate the effect of chlorhexidine digluconate (CRX) application in etched dentin on the retention of noncarious cervical lesions restorations.
A randomized controlled split-mouth and blind trial will be carried out. Patients with at least two non-carious cervical lesions (NCL) will be selected. NCL will be randomly assigned according the type of teeth (incisors, canine or pre-molars) into two groups: control or experimental group (application of 2% CRX for 60 seconds after the acid etching procedure). Class V restorations will be performed out with an etch-and-rinse adhesive system (Adper Single Bond 2-3M ESPE) and a composite resin (Filtek Z350-3M ESPE) according the manufacture instructions, by previously trained operators. The restorations will be evaluated by a calibrate examiner at 1 week (baseline), and 6-month, 12-month and 24-month, using the World Dental Federation (FDI) criteria. The outcome is retention of the restoration.
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 (Participant, Care Provider, 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
- 是
入选标准
- •Patients presenting at least two non-carious cervical lesions (NCL) in anterior, canine or pre-molars;
- •Patients who had more than 20 teeth in the mouth;
- •Patients who were at least 18 years of age at the time of treatment and capable to understand and sign the written informed consent;
- •NCL with at least 1 mm of depth in a vital permanent incisor, canine or premolar of the upper as the lower jaw.
- •NCL in the facial surface of the teeth with sometimes a small part extending interproximally;
- •Patients with good periodontal heath.
排除标准
- •Patients with smoking habits, practicing bruxism, severe systemic diseases, using active orthodontic treatment, malocclusion (Angle Class II or Class III);
- •Tooth with the NCL with the absent of antagonist;
- •NCL wear facets upper than 50% of the incisal/occlusion surface, as a result of tooth attrition;
- •Presence of caries or restorations in the area to be treated;
- •Full-mouth visible plaque index (VPI) or full-mouth gingival bleeding index upper than 20%, probing depth and clinical attachment loss values exceeding 4 mm with bleeding on probing;
- •Unwillingness to return for follow-ups or refuse to participate.
研究组 & 干预措施
Chlorhexidine
Dentin pre-treatment with a experimental solution (chlorhexidine), after the dentin acid etching
干预措施: Treatment with chlorhexidine (Procedure)
Water
Application of water (placebo) after dentin acid etching.
干预措施: Water pre-treatment (Procedure)
结局指标
主要结局
Change from baseline in Retention rates of the restoration at 24 months
时间窗: 6, 12 and 24 months
Patients will be reevaluated at each specified time point and all restoration sites will be evaluated to check if the restoration will be still in place, or if it is missing, or if there is partial retention
次要结局
- Change from baseline in Post-operative sensitivity at 6-month(baseline and 6-month)
- Change from baseline in marginal staining rates at 6. 12 and 24 months(6, 12 and 24 months)
研究者
Maximiliano Sergio Cenci
Associate Professor
Federal University of Pelotas