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临床试验/NCT05013853
NCT05013853已完成不适用

Clinical Performance Resin Bulk Fill Dual-cured of Posterior Restorations: Clinical Study

Universidad Nacional Andres Bello2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2019年5月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
2
主要终点
Compare clinical performance restorations

研究概览

简要总结

Objective: To evaluate the immediate clinical performance using FDI criteria in occlusal and proximal lesions restored with dual polymerization bulkfill composite resin.

Materials and methods: Experimental, clinical, controlled, randomized, double-blind study. For the evaluation of Fill-up! (FU) will be clinically compared to the control groups of a conventional Tetric N-Ceram (TB) RBK and Filtek z350 (z350) conventional composite resin. The adhesive process will be carried out under absolute isolation, of selective etching of 37% orthophosphoric acid enamel before applying the respective adhesive according to the trademark of the composite resins. The evaluation will be to 30 days, 6, 12, 18 and 24 months using the modified FDI criteria of postoperative sensitivity, marginal staining, color, marginal adaptation and anatomy, being 1: Excellent, 2: Good, 3: Fair, 4: unsatisfactory and 5: unacceptable. The non-parametric Kruskal Wallis test and Friedman (95% significance) used to compare the criteria.

详细描述

Prior to the removal of carious lesions, the tooth will be first anesthetized. The lesion areas will be prepared with a diamond rotary instrument (801G.FG.016, Jota AG Rotary Instruments - Switzerland) at high speed and under refrigeration with abundant water. Only damaged tissue conservatively removed. The corresponding measurements it recorded with a millimeter probe (Hu Friedy®, North Carolina, Chicago, USA). Prior to the insertion of the material, the sectional matrix system and the palodent type matrix system and with a wooden wedge will be used. The manufacturer's instructions for each brand of composite resin will be followed. It conditioned with 37% phosphoric acid only in enamel, wash for twice as long and dried. The corresponding adhesive will be used f Single Bond Universal adhesive (3M-Espe, ST. Paul, MN, USA) applied for the z350 group, Tetric N-Bond Universal adhesive (Ivoclar Vivadent AG, Schaan, Liechtenstein) for TB group and One Coat adhesive (Còltene, Whaladent Inc.) for FBK group. In the case of the FBK group, a final layer of Brilliant EverGlow composite resin (Còltene, Whaladent inc) will be added. Figure 3 Photopolymerization procedures performed using an LED light source with a minimum power of 1,100 mW / cm2 (Bluephase Style, Ivoclar Vivadent, AG, Schaan, Liechtenstein). The centric and eccentric occlusal contacts were verified and adjusted. For the finishing and polishing of both protocols, flexible discs (3M ESPE, St. Paul, USA) and the Enhance system (Dentsply, Petrópolis, RJ, Brazil) were used.

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, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy volunteers,
  • high cariogenic risk,
  • availability for clinical follow-up,
  • have at least 3 teeth with occlusal and / or proximal carious lesions of molars or premolars with occlusal and proximal contact,
  • lesions less than 1/3 of inter-cuspal distance and depth> 3 mm in the cervical-occlusal direction and margin on enamel

排除标准

  • Impossibility wash their teeth
  • evidence of xerostomia
  • uncontrolled periodontal disease,
  • pregnant or breastfeeding
  • bruxism or with temporomandibular disorder
  • history of allergy to acrylic or its derivatives,
  • portador of removable prostheses endodontically treated teeth
  • cracked teeth and periapical pathology or pulp pathology symptoms.

结局指标

主要结局

Compare clinical performance restorations

时间窗: 24 months

Outcome measure is Clinical performance of composite resin restoration, Device for measurement is FDI system , Unit is Ranking system has 5 scores for each different criterion. Either restoration is clinically 1: excellent, 2: good, 3:sufficient, 4: unsatisfactory, 5: clinically poor.

次要结局

未报告次要终点

研究者

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

Patricio Vildosola Grez

Clinical Professor

Universidad Nacional Andres Bello

研究点 (2)

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