Evaluation of Bioactive Dental Restorative Materials in Class II Restorations: A Controlled Randomized Split-Mouth Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Retention and fracture of restorations
研究概览
简要总结
This randomized split-mouth clinical trial aims to evaluate the clinical performance of bioactive restorative materials used in Class II restorations in permanent posterior teeth. The study compares a giomer-based bulk-fill restorative material, a giomer restorative material, and a resin-modified glass ionomer cement in terms of clinical success and overall clinical performance. Patients requiring at least three Class II restorations in posterior teeth are treated under standardized clinical conditions. Clinical evaluations are performed at baseline and follow-up visits to assess short- and long-term outcomes.
详细描述
This is a single-center, randomized, controlled split-mouth clinical trial conducted at Hacettepe University Faculty of Dentistry. The aim of the study is to compare the clinical performance of bioactive restorative materials used in Class II posterior restorations.
Eligible patients requiring at least three Class II restorations in permanent posterior teeth are included in the study. Each patient receives restorations with different bioactive restorative materials in separate treatment sites according to a split-mouth design. The tested materials include a giomer-based bulk-fill restorative material, a giomer restorative material, and a resin-modified glass ionomer cement. Randomization is used to assign the restorative materials to the treatment sites.
All restorative procedures are performed under standardized clinical protocols. Clinical performance is evaluated using modified FDI criteria.
Follow-up evaluations are planned at 6, 12, and 24 months after treatment. The 6-month results are used for interim analysis, while long-term follow-up will assess the durability and clinical success of the restorative materials.
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 and outcome assessors were blinded to the restorative material assigned to each treatment site. The operator was aware of the material allocation during the restorative procedures.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy individuals without any systemic disease that could contraindicate restorative treatment
- •Individuals aged between 18 and 50 years
- •Individuals who agreed to participate in the study and signed the informed consent form
- •Individuals with at least three proximal carious lesions in premolar or molar teeth, classified as D2 (lesions extending to the middle third of dentin) or D3 (lesions extending to the inner third of dentin) according to the ICDAS classification
- •Teeth with intact enamel and dentin structure that had not been previously restored
- •Individuals who brushed their teeth at least twice a day
- •Individuals without physical disabilities that could prevent attendance at follow-up visits
- •Individuals with at least 20 teeth in occlusion and with antagonist teeth in the opposing arch
- •Vital teeth without signs of periapical pathology
- •Periodontally healthy teeth that were not used as abutments for any prosthetic restoration
- •Teeth without displacement or mobility
- •Individuals who had undergone initial periodontal therapy
排除标准
- •Pregnant or breastfeeding individuals
- •Individuals with advanced periodontal disease
- •Individuals using removable partial dentures
- •Individuals with bruxism
- •Individuals with severe malocclusion
- •Individuals with known allergies to resin-based restorative materials or adhesive agents
- •Individuals with a history of allergy to local anesthetics or their administration
- •Individuals with latex allergy
- •Individuals with poor oral hygiene
- •Teeth that had been previously restored or were undergoing orthodontic treatment
研究组 & 干预措施
Giomer Restorative Material
Class II posterior restorations restored with a giomer restorative material under standardized clinical conditions.
干预措施: Giomer Restorative Material (Device)
Giomer-Based Bulk-Fill Restorative Material
Class II posterior restorations restored with a giomer-based bulk-fill restorative material under standardized clinical conditions.
干预措施: Giomer-Based Bulk-Fill Restorative Material (Device)
Resin-Modified Glass Ionomer Cement
Class II posterior restorations restored with a resin-modified glass ionomer cement under standardized clinical conditions.
干预措施: Resin-Modified Glass Ionomer Cement (Device)
结局指标
主要结局
Retention and fracture of restorations
时间窗: 6 Months after restoration placement"
Retention and fracture of Class II restorations will be evaluated using modified FDI World Dental Federation criteria by a single examiner. Restorations will be scored based on the presence of loss of retention, fracture, or chipping. A score of 1 (excellent) or 2 (good) will be considered clinically successful.
Marginal adaptation of restorations
时间窗: 6 Months after restoration placement"
Marginal adaptation will be assessed using modified FDI criteria by a single examiner. The presence of marginal gaps or discrepancies will be evaluated using visual inspection.
Surface luster of restorations
时间窗: 6 Months after restoration placement"
Surface luster will be assessed using modified FDI criteria by a single examiner. The surface gloss and texture of restorations will be evaluated.
Postoperative sensitivity
时间窗: 6 Months after restoration placement"
Postoperative sensitivity will be assessed using modified FDI criteria by a single examiner. Sensitivity will be evaluated based on clinical examination and patient-reported symptoms.
Secondary caries
时间窗: 6 Months after restoration placement"
Secondary caries will be evaluated using clinical and radiographic examination according to modified FDI World Dental Federation criteria by a single examiner. Radiographic evaluation will be used to detect recurrent caries and any pathological findings adjacent to the restorations.
次要结局
- Restoration survival(12 and 24 months after restoration placement)
研究者
Ekin Dermanlı
Research Assistant, Department of Restorative Dentistry
Hacettepe University