Clinical Evaluation of Bioactive Injectable Hybrid Resin Composite Restoration With or Without Air Abrasion Surface Pretreatment in the Repairing Capacity of Defective Composite Restoration, A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Change in the clinical performance
研究概览
简要总结
This study is conducted to compare the efficacy of surface pretreatment using air abrasion sandblasting aluminum oxide particles (Al2O3) versus not pretreatment in the repair capacity of defective composite restoration indicated for repair.
详细描述
First the rationale for the repair, rather than the replacement of defective direct composite restorations proved a less invasive procedure with decreased tooth loss avoiding weakening and overtreatment of tooth. Less traumatic or stressful than replacement for patients with good acceptance; Increased longevity of the restoration; Reduction of potentially harmful effects on the dental pulp and Less risk of iatrogenic damage to adjacent teeth.
Secondary using surface treatment strategies aim to prepare a clean surface with high surface energy to provide better wettability with adequate surface roughness and surface area by removing the superficial layer of the aged composite which lead to increase integrity between old and new resin restoration.
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)
盲法说明
Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Co-operative patients approving to participate in the trial.
- •patient with occlusal defects class I or class II composite resin restorations indicated for repair.
排除标准
- •Allergic history concerning methacrylate.
- •Rampant caries.
- •Disabilities patient
- •Pregnancy
- •Heavy smoking.
- •Xerostomia.
- •Lack of compliance.
- •Evidence of parafunctional habits.
- •Temporomandibular joint disorders.
研究组 & 干预措施
surface pretreatment sandblasting
Air abrasion sandblasting aluminum oxide particles (Al2O3) Aqua Care single (London, UK) will be done for the defective area then repairing with bioactive injectable composite, Beautiful Flow Plus X F00 (Shofu, Japan).
The surface treatment for aged composite will be applied according to manufacturer instructions.
Repairing with bioactive injectable composite, Beautiful Flow Plus X F00(Shofu, Japan) The material will be applied according to manufacturer instructions. After shade selection incremental insertion in layers not exceeding 2 mm and light curing for 10 sec using 3M Eliper curing unite (Elipar Deepcure-S, 3M).
干预措施: Air abrasion sandblasting aluminum oxide particles (Al2O3) AquaCare single (Velopex, Medivance Instruments Ltd., London, UK) (Device)
Repairing with conventional nanohybrid composite
The nanohybrid resin composite will be applied to the the cavity using the conventional incremental technique according to manufacturer instructions.
干预措施: Air abrasion sandblasting aluminum oxide particles (Al2O3) AquaCare single (Velopex, Medivance Instruments Ltd., London, UK) (Device)
结局指标
主要结局
Change in the clinical performance
时间窗: Change from the baseline at 12 months
Change in the clinical performance Measured using modified USPHS criteria for clinical evaluation of restoration failure. Measuring Unit: Scoring system (Ordinal): * Alfa * Bravo * Charlie * Delta
次要结局
未报告次要终点
研究者
Ahmed Salah Abdel-Aty hassan
Assistant lecturer, conservative department
Cairo University