A 5-year Clinical Trial Assessing the Effects of a Surface Sealant on Composite Resin Class I Restorations
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 主要终点
- Resin composite Longevity
研究概览
简要总结
This trial, based on a split mouth and double-blind design, will evaluate the effects of a surface sealant on the clinical performance of composite resin class I restorations. According to eligibility criteria, 10 pairs of upper and lower molars or premolars will be restored with Esthet X composite resin. For each pair, one surface will be sealed with Lasting Touch surface sealant. A clinical evaluation will be performed by two experienced operators using modified USPHS (United States Public Health service) after 5 years after treatment. Data will be analyzed using the McNemar test (p < 0.05).
详细描述
The protocol was approved by the Human Ethics Committee (protocol number 133/2010, CAAE 0124.0.224.000.-10), and all patients will sign informed consent forms and complete a registration form prior to treatment.
The eligibility criteria for participation in the study include good oral hygiene, a class I caries lesion or unsatisfactory restoration in at least two posterior teeth (molar or premolar), a buccolingual extension, and a signed consent form. The exclusion criteria includes patients with a proximal caries lesion, the presence of periodontal disease, symptomatic restored or nonrestored teeth indicating irreversible pulpal pathology, an abnormal occlusion or the absence of antagonist teeth, exposure of pulpal tissue, and extended or large cavities.
This study will include 10 patients (aged 18 to 45 years) totaling 14 pairs of class I restorations (molars and premolars). These pairs will be randomly divided into two study groups, resulting in a split-mouth design.
A hybrid resin composite, Esthet X (Dentsply, Caulk, USA) and an etch-and-rinse two-step adhesive, AdperTM Single Bond (3M, ESPE) will be used for the composite restorations. For teeth with the surface sealant, they will be covered with Lasting Touch (Dentsply, Caulk, USA).
All cavity preparations and restorations will be performed by the same experienced operator, using rubber dam isolation. Cavity designs will be prepared using a #245 carbide bur (KG Sorensen, Cotia, SP, Brazil), which will be changed every five preparations. All enamel bordered cavity margins will be verified.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Good oral hygiene;
- •Having a class I caries lesion or unsatisfactory restoration in at least two posterior teeth (molar or premolar);
- •Be in agreement and sign the consent form.
排除标准
- •Patients with a proximal caries lesion;
- •Presence of periodontal disease;
- •Presence of symptomatic restored or non restored teeth indicating irreversible pulpal pathology;
- •Presence of an abnormal occlusion or the absence of antagonist teeth;
- •Presence of exposure of pulpal tissue;
- •Presence of extended or large cavities.
研究组 & 干预措施
No Surface Sealant
Resin composite only
干预措施: No surface sealant (Procedure)
With surface Sealant
Resin composite with surface sealant application
干预措施: Surface sealant (Procedure)
结局指标
主要结局
Resin composite Longevity
时间窗: baseline
A clinical evaluation will be performed by two experienced operators using modified USPHS (United States Public Health service) at baseline, before the treatment. The parameters included will be marginal discoloration, anatomic form, secondary caries and marginal integrity.
次要结局
- Resin composite longevity(5-year)
研究者
Flavia Pardo Salata Nahsan
Principal Investigator
Universidade Federal de Sergipe