Clinical Performance of One-Bottle Versus Two-Bottle HEMA- Free Universal Adhesives in Restoring Anterior Cervical Carious Lesions: A 12-Month Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Restoration retention
研究概览
简要总结
This randomized controlled clinical trial aims to compare the 12-month clinical performance of two HEMA-free universal adhesive systems for restoring anterior cervical carious lesions. Participants will be randomly allocated (1:1) to receive restorations using either a two-bottle HEMA-free universal adhesive (G2-Bond Universal) or a one-bottle HEMA-free universal adhesive (BeautiBond Xtreme), both applied in self-etch mode. The primary outcome is restoration retention, while secondary outcomes include marginal adaptation, marginal discoloration, and postoperative sensitivity, evaluated at baseline (24 hours), 6 months, and 12 months using the modified USPHS criteria.
详细描述
This single-center, parallel-arm, randomized controlled clinical trial will be conducted at the Department of Conservative Dentistry, Faculty of Dentistry, Cairo University. Fifty participants with ICDAS 3 or 4 anterior cervical carious lesions will be randomly assigned in a 1:1 ratio to receive restorations using either G2-Bond Universal (two-bottle HEMA-free universal adhesive) or BeautiBond Xtreme (one-bottle HEMA-free universal adhesive), both applied in self-etch mode and restored with Beautifil II LS composite resin. Clinical performance will be evaluated at baseline (24 hours), 6 months, and 12 months using the modified USPHS criteria. The primary outcome is restoration retention. Secondary outcomes include marginal adaptation, marginal discoloration, and postoperative sensitivity. Participants and outcome assessors will be blinded, while the operator cannot be blinded because of differences in the adhesive application protocols.
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
Participants and outcome assessors will be blinded to the allocated adhesive system. The operator cannot be blinded because the two adhesive systems require different clinical application protocols.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •. Patients aged from 18 to 55 years.
- •Patients with cervical carious lesions on the labial surfaces of anterior teeth.
- •Lesions classified as ICDAS 3 and
- •Patients with good general health.
- •Patients able and willing to attend the follow-up visits at baseline, 6 months and 12 months.
排除标准
- •Patients with severe or chronic periodontal disease.
- •Patients with poor oral hygiene or uncontrolled plaque accumulation.
- •Patients with bruxism or other parafunctional habits that may affect restoration survival.
- •Non-vital teeth.
- •Fractured or cracked teeth.
- •Teeth with defective existing cervical restorations.
- •Root caries extending beyond the restorative indication of the study.
- •Pregnant or lactating patients.
- •Patients with known allergy or hypersensitivity to any component of the adhesive systems or restorative material used in the study.
- •Patients unable to attend the scheduled follow-up visits.
研究组 & 干预措施
Two-bottle HEMA-free Universal Adhesive
Restoration of anterior cervical carious lesions using G2-Bond Universal (GC Corporation) in self-etch mode followed by Beautifil II LS composite resin.
干预措施: G2-Bond Universal (Device)
One-bottle HEMA-free Universal Adhesive
Restoration of anterior cervical carious lesions using BeautiBond Xtreme Universal Adhesive (Shofu) in self-etch mode followed by Beautifil II LS composite resin.
干预措施: BeautiBond Xtreme Universal Adhesive (Device)
结局指标
主要结局
Restoration retention
时间窗: 12 Months
Clinical assessment of restoration retention using the Modified United States Public Health Service (USPHS) criteria at baseline, 6 months, and 12 months. Retention will be recorded as ordinal categorical data using two categories: Alpha (complete restoration retention; best clinical outcome) and Charlie (partial or complete loss of the restoration requiring repair or replacement; worst clinical outcome and considered failure).
次要结局
- Marginal adaptation(12 months)
- Marginal discoloration(12 months)
- Postoperative sensitivity(12 months)
研究者
Mariam Salem
MSc Candidate in Restorative dentistry
Cairo University