Evaluation of Cervical Restorations Performance Using Modified Universal Adhesive Compared to Conventional Universal Adhesive: A Randomized Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Marginal adaptation
研究概览
简要总结
Class V restorations are evaluated to reveal whether the use of modified universal adhesive will have a similar performance compared to conventional universal adhesive or not.
详细描述
The innovative Scotchbond Universal Plus Adhesive offers all the benefits of its predecessor, Single Bond Universal Adhesive as demonstrated by a 3M field evaluation comparing the performance of the two products. These benefits include:
- Compatibility with all etching techniques - total-etch, self-etch, and selective enamel etch.
- Usage with direct and indirect indications.
- Bonding to all dental surfaces without the need for separate primers or silanes
- Virtually no post-operative sensitivity.
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 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, long-term clinical evaluations are needed to demonstrate the value of universal bonding agents adequately. So, the aim of this study is to evaluate the clinical performance of the modified universal adhesive, versus the conventional universal adhesive, for restoring carious class V cavities over one year and a half.
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
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Small to moderate carious cervical lesions. (ICDAS scores 3,4)
- •Upper premolar teeth.
- •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 TMJ disorders.
- •Class V lesions in molars.
- •Non-carious cervical lesions.
- •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.
研究组 & 干预措施
Carious cervical lesions treated with modified universal adhesive
Preparation of class V cavity with removal of caries and beveling of margins is done followed by total etching prior to application of modified universal adhesive. The cavity is then restored with nano-filled resin composite.
干预措施: Modified universal adhesive (Drug)
Carious cervical lesions treated with conventional universal adhesive
Preparation of class V cavity with removal of caries and beveling of margins is done followed by total etching prior to application of conventional universal adhesive. The cavity is then restored with nano-filled resin composite.
干预措施: Conventional universal adhesive (Drug)
结局指标
主要结局
Change in Marginal adaptation
时间窗: Baseline, 6 months, 12 months, 18 months and 24 months.
using Modified USPHS criteria
次要结局
- Marginal discoloration(Baseline, 6 months, 12 months, 18 months and 24 months.)
- Post-operative sensitivity(Baseline, 6 months, 12 months, 18 months and 24 months.)
- Retention(Baseline, 6 months, 12 months, 18 months and 24 months.)
- Secondary caries(Baseline, 6 months, 12 months, 18 months and 24 months.)
研究者
Basma Gamal Dawoud
Principal investigator
Cairo University