跳至主要内容
临床试验/NCT05211908
NCT05211908Unknown不适用

Clinical Performance of Different Adhesive Strategies With a Universal System in Sclerosed Dentin in NCCL: A Double-blind Randomized Clinical Trial.

Universidade Federal do Para1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年7月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
Retention

研究概览

简要总结

The aim of this randomized, prospective, parallel, double-blind clinical trial will be to evaluate the clinical performance of restorations performed in non-carious cervical lesions (NCCL) using a soft ph universal adhesive system, varying the adhesive strategy (self-etching vs. selective etching of the enamel) and the sclerosis characteristics of the dentinal substrate over 24 months.

详细描述

Two hundred restorations will be performed in NCCL of volunteers of both genders, by a single operator, using the Single Bond Universal(3M ESPE) adhesive system. The restorations will be randomly allocated into 4 groups (n-50): D-SE (absence of dentinal sclerosis and self-etching protocol); D-SELETIVE (absence of dentinal sclerosis and selective enamel etching protocol); SD-SE (sclerotic dentin and self-etching protocol); SD-SELETIVE (sclerotic dentin and selective enamel etching protocol). The randomization process within subject was performed by computer-generated tables by a staff member not involved in the research protocol. Details of the allocated group were recorded on cards contained in sequentially numbered, opaque, sealed envelopes. These were prepared by a staff member who was not involved in any of the phases of the clinical trial. The allocation assignment was revealed by opening the envelope on the day of the restorative procedure.The operator was not blinded to group assignment when administering.

The evaluations of the clinical performance of the restorations will be carried out by two previously calibrated examiners, adopting the criteria of the United States Public Health Service (USPHS) for the variables retention, marginal adaptation, marginal staining and postoperative sensitivity . The intragroup statistical analysis will be performed using the McNemar test for the variables retention and postoperative sensitivity; and by Wilcoxon for adaptation and marginal staining. To compare the clinical performance inter groups in the different assessment intervals, Fisher's exact test (retention and postoperative sensitivity) and Kruskal-Wallis (adaptation and marginal staining) will be 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
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • •Good general health status
  • •Good oral hygiene
  • •Absence of periodontal disease
  • •Minimum of 20 teeth in occlusion
  • •Presence at least one (01) non-carious cervical lesion in a tooth with pulp vitality.
  • •Non-carious cervical lesion greater than 1mm in depth.
  • •Non-carious cervical lesion involving enamel and dentin.

排除标准

  • •Non- carious cervical lesion cavo surface margin involving more than 50% of the enamel.
  • •NCCL in crack teeth.
  • •Absence of opposing teeth and/or adjacent to the lesion.
  • •Presence of occlusal trauma in the NCCL tooth
  • •Presence of orthodontic appliance or removable partial denture with retention in the tooth where the lesion is located
  • •Patients that underwent tooth whitening procedures within a period of less than 14 days from the date of restoration
  • •Patients with high risk of caries (presence of three or more active caries lesions)
  • •Xerostomia
  • •Pregnant women
  • •Patients who do not accept the study conditions

研究组 & 干预措施

D-SE

Experimental

Absence of dentinal sclerosis and self-etching adhesive protocol

干预措施: Composite resin restoration with Self Etch adhesive protocol and absence of sclerotic dentin (Procedure)

D-SELETIVE

Active Comparator

Absence of dentinal sclerosis and selective enamel etching adhesive protocol

干预措施: Composite resin restoration with Seletive enamel etch adhesive protocol and absence of sclerotic dentin (Procedure)

SD-SE

Experimental

Sclerotic dentin and self-etching adhesive protocol

干预措施: Composite resin restoration with Self Etch adhesive protocol and presence of sclerotic dentin (Procedure)

SD-SELETIVE

Experimental

Sclerotic dentin and selective enamel etching adhesive protocol

干预措施: Composite resin restoration with Seletive enamel etch adhesive protocol and presence of sclerotic dentin (Procedure)

结局指标

主要结局

Retention

时间窗: 2 years

The restorations retention will be evaluated according to the criteria established by the United States Public Health Service (USPHS), classifying them in the following scores: Alpha - retained Bravo - partially retained Charlie - restoration lost For evaluation of clinical performance, beta and charlie scores will be considered as failure.

Retention

时间窗: 1 year

The restorations retention will be evaluated according to the criteria established by the United States Public Health Service (USPHS), classifying them in the following scores: Alpha - retained Bravo - partially retained Charlie - restoration lost For evaluation of clinical performance, beta and charlie scores will be considered as failure.

次要结局

  • Marginal adaptation(2 years)
  • Marginal staining(2 Years)
  • Marginal adaptation(1 year)
  • Marginal staining(1 Year)

研究者

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

Cecy Martins Silva

Clinical professor

Universidade Federal do Para

研究点 (1)

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