Clinical Performance of Universal Adhesive With and Without Acid Resistant Silane Coupling Agent in Carious Cervical Lesions :A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Retention (Success rate)
研究概览
简要总结
Evaluation of composite restorations done in carious cervical lesions restored by a conventional universal adhesive in comparison to a universal adhesive that contains and resistant silane coupling agent according to the Modified United States Public Health Service (USPHS) criteria over 18 months.
详细描述
The presence of acidic monomers in the bottle during storage can lead to the hydrolysis of silane contained in universal adhesives, potentially reducing its effectiveness and causing instability,The acid resistant silane coupling agent has a protective structure against attacks from acidic monomers. Therefore, long-term storage stability can be expected by suppressing hydrolysis. The protective structure is removed when the concentration of acidic monomers increases by air drying after application. This activates ARS, exerting the silane coupling effect.
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
- 21 Years 至 67 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants Inclusion:
- •Adults aging from 21-67 years old who were in need of restoration of at least one notch-shaped cervical lesion
- •Teeth Inclusion:
- •Vital teeth with carious cervical lesions in incisors , canines ,premolars& molars
排除标准
- •Participants Exclusion:
- •Patients with fewer than 20 teeth
- •Poor oral hygiene
- •Uncontrolled periodontal disease
- •Xerostomia
- •Known allergy to resin-based materials
- •Medically compromised, pregnant, or breast-feeding
- •Teeth Exclusion:
- •Non vital teeth
- •Teeth that are out of occlusion
- •Previously restored teeth
结局指标
主要结局
Retention (Success rate)
时间窗: T0=baseline 24 hours postoperative. T1=12 months postoperative. T2=18 months postoperative.
Alpha (A) Present Bravo (B) Partial loss but clinically acceptable Charlie (C)Clinically unacceptable partial loss or absent
次要结局
- Marginal discoloration(T0=baseline 24 hours postoperative. T1=12 months postoperative. T2=18 months postoperative.)
- Secondary caries(T0=baseline 24 hours postoperative. T1=12 months postoperative. T2=18 months postoperative.)
- Marginal adaptation(T0=baseline 24 hours postoperative. T1=12 months postoperative. T2=18 months postoperative.)
研究者
Ahmed El-Kotaby
Prinicipal investigator
Cairo University