Clinical Evaluation of Wear Resistance and Bioactivity of Self Cured Bioactive Resin Composite
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Assessment of the bioactivity
研究概览
简要总结
Introduction:
Resin-based composites (RBCs) have become the gold standard in restorative dentistry due to their superior aesthetics, adhesion, and minimally invasive application. However, wear remains a critical drawback, compromising their longevity and clinical performance. Various techniques have been suggested to measure the clinical performance of (RBCs). Recent advancements in digital dentistry, such as intraoral scanning, offer a more precise and efficient approach for quantitative wear assessment.
Aim:
This study aims to evaluate wear resistance and bioactivity of self cured bioactive resin composite vs nanhybrid resin composite.
Methodology:
Twelve healthy patients with 24 carious molar teeth will be selected where each patient should have two oclusso- mesial cavities. Standardized oclusso- mesial cavities will be prepared for all the selected teeth, for each patient the first tooth will be restored with conventional nanohybrid RBC (M1). Meanwhile, the second tooth will be restored by self-cure bioactive RBC (M2). Then, wear resistance will be evaluated by intraoral scanner immediately after restoration (T0), six months later (T1), after 12 months (T2), 18 months (T3) and 24 months (T4). Software analysis will be done by superimposing the 3D digital impression and evaluate the restoration wear by calculating the 3D volume loss.
Also, bioactivity of the restoration will be measured by measuring the mineral density beneath the restoration. Digital radiographic images will be taken for the restoration by parallel technique and grey scale of the pixels under restoration will be measured by software immediately after restoration (D0), one month later (D1) and after 3 months (D2).
详细描述
II- 1 Study Setting:
A randomized controlled double-blinded clinical trial will be conducted where both patient and examiners will be blinded to the group assignment. Patients of age group 21-45 years will be selected where each patient should have two oclusso- mesial cavities. Patients will be recruited from the outpatient clinic of Conservative Dentistry department in the Faculty of Dentistry, Suez Canal University. During the initial examination, the purpose and the method of the research will be explained to the patients and a written informed consent will be assigned by each individual.
II-2 Sample Selection:
Patients participating in this study will be selected according to the following eligibility criteria:
II-2-a Inclusion Criteria:
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, Investigator)
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with vital two molar teeth with compound class II deep carious lesions.
- •Both males and females will be included.
- •Patients with good general health.
- •Patients with good oral hygiene.
- •Co-operative patients.
- •Absence of spontaneous pain, mobility or tenderness on percussion.
- •Radiographically: no internal or external resorption, no periapical or furcation radiolucency and no widening of the periodontal ligament space.
排除标准
- •Patients with systemic disease.
- •Patients with severe or chronic periodontitis.
- •Patients having allergy to the materials used in this trial.
- •Nonfunctioning teeth.
- •Teeth with any pathologic pulpal changes.
- •Teeth with previous restorations.
- •Teeth with surface loss due to non carious lesions.
研究组 & 干预措施
Light cured nanohybrid RBC restorations
Conventional nanohybrid composite placement for Class II restorations
干预措施: Resins, Composite nanohybrid (Procedure)
"Self-cured Bioactive Resin Composite."
Self-cured bioactive composite placement for Class II restorations
干预措施: Resins, Composite bioactive (Procedure)
结局指标
主要结局
Assessment of the bioactivity
时间窗: immediately after restoration (D0) ; one month (D1) and three months (D2)
Bioactivity of each examined restoration will be determined by the evaluation of mineral density beneath the tested materials. Immediately after restoration (D0), an image plate digital sensor (Xios XG Supreme, Dentsply Sirona, UK) will be used for transmitting the radiographic image of the selected tooth to the computer. Later, each restoration will be examined at standardized follow-up periods. All the radiographs will be evaluated for the outcome by a software (ImageJ software, NIH, USA).
wear resistance
时间窗: Immediately after restoration, six months (T1), twelve months (T2), eighteen months (T3) and twenty-four months (T4).
A digital impression will be taken immediately after restoration (T0) using an intraoral scanner (Helios 600 intraoral scanner, Eighteeth, Changzhou, China). To ensure optimal performance and accuracy, the scanner underwent regular calibration before scanning each patient, following the manufacturer's recommendations. During the scanning procedure, the device will be positioned at a 90° angle for the occlusal surface and at 45° angles for both buccal and lingual surfaces. Later on, each restoration will be examined at standardized follow-up periods; six months (T1), twelve months (T2), eighteen months (T3) and twenty-four months (T4). The 3D impressions will be analyzed using a software (Geomagic software, 3D Systems Inc., USA) program and the impressions of each two consultative visits will be superimposed to determine the wear volume loss (mm3)
Assessment of the bioactivity
时间窗: immediately after restoration (D0) ; one month (D1) and three months (D2)
Bioactivity of each examined restoration will be determined by the evaluation of mineral density beneath the tested materials. Immediately after restoration (D0), an image plate digital sensor (Xios XG Supreme, Dentsply Sirona, UK) will be used for transmitting the radiographic image of the selected tooth to the computer. Later, each restoration will be examined at standardized follow-up periods. All the radiographs will be evaluated for the outcome by a software (ImageJ software, NIH, USA).
wear resistance
时间窗: Immediately after restoration, six months (T1), twelve months (T2), eighteen months (T3) and twenty-four months (T4).
A digital impression will be taken immediately after restoration (T0) using an intraoral scanner (Helios 600 intraoral scanner, Eighteeth, Changzhou, China). To ensure optimal performance and accuracy, the scanner underwent regular calibration before scanning each patient, following the manufacturer's recommendations. During the scanning procedure, the device will be positioned at a 90° angle for the occlusal surface and at 45° angles for both buccal and lingual surfaces. Later on, each restoration will be examined at standardized follow-up periods; six months (T1), twelve months (T2), eighteen months (T3) and twenty-four months (T4). The 3D impressions will be analyzed using a software (Geomagic software, 3D Systems Inc., USA) program and the impressions of each two consultative visits will be superimposed to determine the wear volume loss (mm3)
次要结局
未报告次要终点