Clinical Performance of Repaired Resin Composite Restorations Using Separate Silane Coupling Agent Versus Adhesives Containing Regular or Acid Resistance Silane: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 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
- 是
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
研究组 & 干预措施
Silane coupling agent(Comparator)
In the control group, Silane coupling agent (Porcelain primer) will be applied following the acid etch rinsing and drying step, for 30 seconds and then it will be thoroughly dried using air syringe then universal adhesive with regular silane will be actively applied for 20 seconds and then it will be light cured for 20 seconds and final restoration will be done.
干预措施: Silane coupling agent (Other)
.Adhesive containing silane.(Intervention 1 )
Universal adhesive with regular silane will be applied for 20 seconds, air thinned for 10 seconds and then it will be light cured for 20 seconds and final restoration will be done using same resin composite material
干预措施: Adhesive containing silane.(Intervention 1 ) (Other)
Acid resistance silane containing adhesive.(Intervention 2)
Acid resistance silane containing adhesive will be applied for 20 seconds, dry with gentle air for 3 seconds, then with stronger air and light cured for 10 seconds and final restoration will be done
干预措施: Acid resistance silane containing adhesive.(Intervention 2) (Other)
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
- 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.)
- Anatomical form(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
Yasmin Fathy Talaat
Principal Investigator
Cairo University