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临床试验/NCT03254693
NCT03254693已完成4 期

STRATEGIES FOR BONDING TO ENAMEL USING A UNIVERSAL ADHESIVE ON SELF-ETCHING MODE

Universidade Estadual de Ponta Grossa2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2016年2月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
35
试验地点
2
主要终点
Retention

研究概览

简要总结

Objective: This double-blind randomized clinical trial evaluates strategies for improving the bonding of universal adhesive to enamel in non-carious cervical lesions (NCCL) of a new universal multi-mode adhesive (Ambar Universal; FGM).

Methods: A total of 134 restorations were randomly placed in 19 patients according to the following groups: SE - Self-etch; SEE - Selective etching; SE2X - Self-etch doble time; SE1+ - Self-etch additional layer. The resin composite Opallis (FGM) was placed incrementally. The restorations were evaluated after one week (baseline), 6 and 12 months, using the FDI and USPHS criteria. Statistical analyses were performed using appropriate tests (=0.05).

详细描述

Interventions: restorative procedure All the patients selected for this study received dental prophylaxis with a suspension of pumice and water in a rubber cup and signed an informed consent form two weeks before the restorative procedures.

The degree of sclerotic dentin from the NCCLs was measured according to the criteria described by Swift and others. The cavity dimensions in millimeters (height, width, and depth), the geometry of the cavity (evaluated by profile photograph and labeled at <45o, 45o-90o, 90o<135o, and >135o), the presence of an antagonist, and the presence of attrition facets were observed and recorded. Pre-operative sensitivity was also evaluated by applying air for 10 s from a dental syringe placed 2 cm from the tooth surface and with an explorer. These features were recorded to allow comparison of the baseline features of the dentin cavities among experimental groups.

To calibrate the restorative procedure, the study director placed one restoration of each group to identify all steps involved in the application technique. Then, the two operators, who were resident dentists with more than five years of clinical experience in operative dentistry, placed four restorations, one of each group, under the supervision of the study director in a clinical setting. The restoration failures were shown to the operators prior to starting the study. At this point, the operators were considered calibrated to perform the restorative procedures.

The operators restored all teeth. All participants received four restorations, one of each experimental group in different lesions previously selected according to the inclusion criteria.

Before restorative procedures, the operators anesthetized the teeth with a 3% mepivacaine solution (Mepisv, Nova DFL, Rio de Janeiro, RJ, Brazil) and cleaned all lesions with pumice and water in a rubber cup, followed by rinsing and drying. Then, shade selection was made using a shade guide.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Double (Participant, Outcomes Assessor)

盲法说明

staff member not involved in the research protocol performed the randomization process with computer-generated tables. Details of the allocated groups were recorded on cards contained in sequentially numbered, opaque, sealed envelopes. Opening the envelope only on the day of the restorative procedure guaranteed the concealment of the random sequence. The examiners were not involved with the restoration procedures and therefore blinded to the group assignment, performed the clinical evaluation. Patient were also blinded to group assignment in a double-blind randomized clinical trial design.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants had to be in good general health.
  • At least 18 years old
  • Have an acceptable oral hygiene level
  • Present at least 20 teeth under occlusion
  • At least four NCCLs in four different teeth
  • These lesions had to be non-carious, non-retentive, deeper than 1 mm, and involve both the enamel and dentin of vital teeth without mobility.
  • The cavo-surface margin could not involve more than 50% of enamel, and all lesions had cervical margins ending in dentin.

排除标准

  • Participants had not be in good general health.
  • At less 18 years old
  • Have not an acceptable oral hygiene level
  • Present at less 20 teeth under occlusion
  • At less four NCCLs in four different teeth, these lesions had not be non-carious, retentive and involve only enamel of vital teeth with mobility.

研究组 & 干预措施

selective enamel etching (SEE)

Active Comparator

According to the manufacturer's instructions.

干预措施: selective enamel etching (SEE) (Combination Product)

1-step self-etch for double time (SE2X)

Experimental

According to the manufacturer's instructions, but for the double time (20 s) in the each application.

干预措施: 1-step self-etch for double time (SE2X) (Other)

1-step self-etch approach (SE)

Active Comparator

According to the manufacturer's instructions.

干预措施: 1-step self-etch approach (SE) (Combination Product)

1-step self-etch additional layer (SE1+)

Experimental

According to the manufacturer's instructions, but apply tree times.

干预措施: 1-step self-etch additional layer (SE1+) (Other)

结局指标

主要结局

Retention

时间窗: 6 montths

The primary clinical endpoint was restoration retention/fracture.

次要结局

  • Marginal Adaptation(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eloisa Andrade de Paula

Doctor

Universidade Estadual do Oeste do Paraná

研究点 (2)

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