Clinical Performance of Highly Viscous Glass Ionomer Versus Bulk Fill Resin Composite Restorative Materials in Moderate Class II Cavities of Permanent Posterior Teeth " A 12-Month Randomized Clinical Study"
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Marginal adaptation of the restoration
研究概览
简要总结
Study Title:
Clinical Performance of Highly Viscous Glass Ionomer versus Bulk Fill Resin Composite Restorative Materials in Moderate Class II Cavities of Permanent Posterior Teeth: A 12-Month Randomized Clinical Study
Study Design:
Split-mouth, randomized clinical trial on 31 patients with at least two moderate Class II carious lesions in permanent posterior teeth. Each patient receives two restorations-bulk fill resin composite on one side and highly viscous glass ionomer (HVGIC) on the other.
Aim:
To compare the clinical performance of bulk fill resin composite and HVGIC restorations over 1 week (baseline), 6 months, and 12 months using the modified United States Public Health Services (USPHS) criteria.
Primary Outcome:
Marginal adaptation of the restorations
Secondary Outcomes:
- Anatomic form
- Contact point
- Restoration retention
- Marginal discoloration
- Surface texture
- Color match
- Secondary caries
- Postoperative sensitivity
Methodology Highlights:
Evaluation by two blinded examiners
Standardized cavity prep and material application
Clinical evaluation using USPHS criteria at all follow-up intervals
Statistical analysis with chi-square, ANOVA, or non-parametric tests as appropriate (R software v4.3.2)
Ethical Considerations:
Approved by the Faculty of Dentistry, Ain Shams University Research Ethics Committee
Informed consent will be obtained from all participants
Significance:
This study helps determine whether HVGIC can be a clinically viable alternative to bulk fill resin composite in moderate Class II cavities, with implications for durability, patient compliance, and cost-effectiveness
详细描述
Title:
Clinical Performance of Highly Viscous Glass Ionomer versus Bulk Fill Resin Composite Restorative Materials in Moderate Class II Cavities of Permanent Posterior Teeth: A 12-Month Randomized Clinical Study
Study Overview:
This study is a prospective, randomized, split-mouth clinical trial designed to compare the clinical performance of bulk fill resin composite and highly viscous glass ionomer (HVGIC) restorative materials in moderate Class II cavities of permanent posterior teeth over a 12-month period. The evaluation of restorations will be based on the modified United States Public Health Services (USPHS) criteria at three time intervals: 1 week (baseline), 6 months, and 12 months post-treatment.
Rationale and Background:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants were unaware of which material was used on each side of the mouth (participant blinding). Two independent, calibrated outcome assessors who were not involved in the treatment procedures and blinded to the allocation evaluated the restorations using the modified USPHS criteria at each follow-up interval.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged 18 to 45 years
- •Systemically healthy individuals
- •Patients with at least two Class II carious lesions (one on each side) in permanent posterior teeth
- •Vital, symptomless teeth
- •Teeth in occlusion and in contact with adjacent natural teeth
- •Healthy periodontal tissues
- •Carious lesions of moderate depth (outer or middle third of dentin radiographically)
- •Patients likely to return for recall visits
排除标准
- •Medically compromised patients
- •Pregnant or breastfeeding women
- •Poor oral hygiene
- •Patients undergoing orthodontic treatment
- •Patients with parafunctional habits (e.g., bruxism)
- •Extensive lesions requiring cusp coverage
- •Absence of adjacent or opposing teeth
结局指标
主要结局
Marginal adaptation of the restoration
时间窗: 1 week (baseline), 6 months, and 12 months after restoration
Clinical evaluation of the marginal adaptation of bulk fill resin composite and highly viscous glass ionomer restorations in moderate Class II cavities using the modified United States Public Health Service (USPHS) criteria. Marginal adaptation will be scored as Alfa (no gap), Bravo (visible defect without dentin exposure), or Charlie (failure with dentin exposure)
次要结局
- Anatomic form of the restoration(1 week (baseline), 6 months, and 12 months after restoration)
- Contact point integrity(1 week (baseline), 6 months, and 12 months after restoration)
- Restoration retention(1 week (baseline), 6 months, and 12 months after restoration)
- Marginal discoloration(1 week (baseline), 6 months, and 12 months after restoration)
- Surface texture(1 week (baseline), 6 months, and 12 months after restoration)
- Color match(1 week (baseline), 6 months, and 12 months after restoration)
- Presence of secondary caries(1 week (baseline), 6 months, and 12 months after restoration)
- Postoperative sensitivity(1 week (baseline), 6 months, and 12 months after restoration)