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临床试验/NCT06392685
NCT06392685尚未招募不适用

Clinical Performance of Repaired Resin Composite Restorations Using Separate Silane Coupling Agent Versus Adhesives Containing Regular or Acid Resistance Silane: A Randomized Controlled Trial

Cairo University0 个研究点目标入组 75 人开始时间: 2024年7月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
75
主要终点
Marginal adaptation

研究概览

简要总结

Evaluation the influence of the use of silane coupling agent application as a separate step versus application of silane or acid resistance silane containing adhesives on the clinical performance of repaired posterior resin composite restorations according to Modified United States Public Health Service (USPHS) criteria over one year.

详细描述

some manufacturers have produced silane-containing adhesives in their new products, which might eliminate the need to apply separate silane. However, this silane coupling agent can be hydrolyzed by the acidic monomer in the adhesive making it useless. Acid resistance silane containing adhesive is the update version of the silane containing adhesive which provides a long lasting effective bond between the old and new resin composite restorations

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Participants Inclusion:
  • Patients aging (18-45). Patients with a high level of oral hygiene. Patients with good likelihood of recall availability. - Teeth Inclusion: The restorations were first placed 12 to 24 months ago. Teeth with healthy remaining tooth structure. Posterior restorations with approximately 3mm in size occlusal marginal defect. Asymptomatic teeth before repair.

排除标准

  • Participants Exclusion:
  • Patient with high caries risk Patient with poor periodontal health. Heavy bruxism habits. Pregnant or lactating females.
  • Teeth Exclusion: The restorations with large defects The restorations in the third molars Last experience with allergic reactions against any components of the used materials.
  • Patients receiving orthodontic treatment

结局指标

主要结局

Marginal adaptation

时间窗: T0= Baseline 24 hours postoperative. T1= 6 months follow up. T2= 12 months follow up.

Alpha (A) Restoration adapts closely to the tooth structure; there is no visible crevice Bravo (B) There is a visible crevice, the explorer will penetrate, without dentin exposure. Charlie(C) The explorer penetrates into a crevice in which dentin or the base is exposed.

次要结局

  • Anatomical form(T0= Baseline 24 hours postoperative. T1= 6 months follow up. T2= 12 months follow up.)
  • Marginal discoloration(T0= Baseline 24 hours postoperative. T1= 6 months follow up. T2= 12 months follow up.)
  • Surface roughness(T0= Baseline 24 hours postoperative. T1= 6 months follow up. T2= 12 months follow up.)
  • Postoperative sensitivity(T0= Baseline 24 hours postoperative. T1= 6 months follow up. T2= 12 months follow up)
  • Secondary caries(T0= Baseline 24 hours postoperative. T1= 6 months follow up. T2= 12 months follow up.)

研究者

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

Yasmin Fathy Talaat

Principal Investigator

Cairo University

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