Radiographic Evaluation of Adaptation of New Radio-opaque Universal Adhesive Compared to Universal Adhesive in Proximal Restorations: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Radiographic Assessment of adaptation of restoration
研究概览
简要总结
Class 2 restorations are analyzed to see whether or not the use of modified universal adhesive will result in similar adaptation to conventional universal adhesive.
详细描述
The newly modified adhesive with its careful formulation offers:
Radiopacity like dentin to reduce the risk of X-ray misdiagnosis and overtreatment. Ability to bond and seal caries-affected dentin to support minimally invasive preparation guidelines and maximize preservation of natural tooth structure. Adhesion to all dental substrates and all direct and indirect materials, including glass ceramics. Full dual- and self-cure compatibility without the need for an additional dual-cure activator bottle. A bisphenol A (BPA) derivative-free formulation to alleviate concerns about BPA in dental materials. A fully aligned system with RelyX™ Universal Resin Cement, offering excellent bond strength for virtually all dual-cure resin cement indications.
As with any new material or technique, clinical evaluations are needed to demonstrate the value of universal bonding agents adequately. Therefore, the aim of the current study was to evaluate adaptation of class 2 restorations either using radio-opaque universal adhesive or universal adhesive using digital radiography.
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
- 19 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Small to moderate carious proximal lesions. (International caries detection and assessment system (ICDAS) scores 3,4)
- •Good oral hygiene (mild to moderate plaque accumulation)
- •Vital teeth with no signs of irreversible pulpitis.
- •Presence of favorable occlusion and normal contact with adjacent teeth.
排除标准
- •Patients with systemic diseases, severe medical complications or allergic history concerning methacrylates.
- •Lack of patient compliance, pregnancy, rampant caries, heavy smoking or xerostomia.
- •Evidence of parafunctional habits and tempromandibular joint disorders.
- •Deep carious defects (close to pulp, less than 1 mm distance).
- •Teeth with signs and symptoms of irreversible pulpitis or pulp necrosis.
- •Endodontically treated teeth.
- •Tooth hypersensitivity.
- •Possible prosthodontic restoration of teeth.
- •Heavy occlusion and occlusal contacts or history of bruxism.
- •Severe periodontal affection.
结局指标
主要结局
Radiographic Assessment of adaptation of restoration
时间窗: 1week
Modified USPHS criteria: Score A : harmonious transition between restoration and tooth; Score B: Presence of adhesive line (Radiolucent zone) below the restoration
次要结局
未报告次要终点
研究者
Omar Osama Shaalan
Associate Professor, Department of Conservative Dentistry
Cairo University