Longevity of Dental Fillings by Chairside Technique Utilizing 3D Printing vs. Direct Composite Fillings
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- The United States Public Health Service (USPHS) criteria; changes during the follow-up period
研究概览
简要总结
The aim of the present study is to compare the success of dental fillings prepared using 3D printing technique to those manufactured with the direct composite technique. A total of 100 adult patients will be selected from dental patients attending Kaarina Municipal Health Care Centre from October 2020. The inclusion criteria are as follows: presence of multiple cavities, fractures or cosmetic demands on bilateral permanent teeth. The restorative demand should be a class II, III or IV on first or second molars, or premolars. At least two fillings should be from the same tooth group (premolar/molar) in each patient. This will be a split-mouth study, whereby one tooth on one side will be restored using direct technique, and the contra lateral tooth restored using the indirect technique through random allocation. For both direct and indirect restorations, commercially available short-fibre reinforced composite material (Ever X Flow, GC) is used for core material (replacing dentin) and flowable composite material (Gaenial Universal Injectable, GC) for surface (replacing enamel, appr. 2mm thickness from the surface), according the manufacturer´s instructions. Clinical evaluations will be conducted immediately after the final finishing, and after 1 year, 3 years and 5 years. The evaluation will be based on the United States Public Health Service (USPHS) criteria. Descriptive statistics will be used to describe the frequency distributions of the evaluated criteria. To analyse the failure rate for direct vs. indirect restorations, 2x2 tables will be created. Non-parametric statistical procedures will be used due to ordinally structured data for the assessment of the restorations. Mann-Whitney U-test will be used to explore significant differences at different time points between direct and indirect restorations.
详细描述
Introduction
In dentistry, filling materials are needed repairing damage caused by dental caries as well as for occlusal rehabilitation. Composite restorations can be performed using direct or indirect technique. There are some shortcomings linked with direct technique, such as polymerization shrinkage, and also their manufacturing can be demanding due to circumstances in the oral cavity. Partly due to these, approximately 8 out 10 regular users of dental services need repetitive repair or replacement of old restorations within 5 years. One solution for manufacturing high-qualified and long-lasting restorations is chairside CAD/CAM (computer-aided design and computer-aided manufacturing) technology that includes both subtractive and additive manufacturing techniques. Additive techniques, also called 3D printing techniques, may provide novel possibilities to overcome the challenges linked with the durability of dental fillings. They might be used to fabricate more complex restorations compared to subtractive techniques with a reasonable cost. In 3D printing, successive layers of material are deposited under computer control to create an object layer by layer. The objects, having practically any shape or geometry, are produced from a model or design in an electronic form. The 3D printable models may be created with a CAD software package and in many cases utilize the imaging data by a dental scanner which have become widely available with high resolution. 3D printing may enable higher restoration accuracy compared to subtractive manufacturing techniques, where the accuracy is limited by the milling unit and machining tools. Another benefit is its low material loss. 3D printing process is fast and likely in future to be used chairside at the dental office. Only a few studies addressing the possibilities of 3D printing in dental filling manufacture exist in the current literature. Based on a previous in vitro study by the imvestigators, the accuracy of 3D printing technique is at least at the same level as milling technique in fabrication of dental inlay and onlay fillings, and thus might be a clinically acceptable alternative to the subtractive milling technique. Additional clinical investigations are needed to confirm these findings. The aim of the present study is to compare the success of dental fillings prepared using 3D printing technique to those manufactured with the direct composite technique.
Material and Methods
At total, 100 adult patients are selected from dental care patients of the Health Centre of Kaarina, Kaarina, Finland, as volunteers. Written informed consent forms are obtained from all patients at the beginning of the study. Participation in the study is voluntary and causes no additional costs for the patient.
Each patient requires two Class II, III or IV cavities to be restored in the dentition. The randomizations are performed by noting each tooth to be restored (Fédération Dentaire Internationale [FDI] two-digit code) on one form and the type of restorative system (direct technique vs. indirect technique utilizing 3D printing) on a second. First, a tooth number is drawn blindly. Subsequently, a restorative system is allocated to this tooth by blind drawing. The clinical procedures of cavity preparation and restoration placement are performed by two experienced dentists.
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
- Single (Outcomes Assessor)
盲法说明
Restorations are rated independently by blinded dentists who are not involved with the insertion of the indirect and the direct restorations and are unaware of the group status of the fillings.
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •presence of cavities, fractures or cosmetic demands
- •first or second molars and permanent premolars needing restorations
- •at least two class II restorations from the same tooth group (premolar/molar) should be performed in each patient
- •the number of restorations of each technique should be equal in each patient
排除标准
- •pulp exposure or risk of it during caries removal or cavities with imminent risk of pulp exposure
- •spontaneous pain or sensitivity to percussion
结局指标
主要结局
The United States Public Health Service (USPHS) criteria; changes during the follow-up period
时间窗: baseline, and 1 year, 3 years and 5 years after baseline
The USPHS criteria include the following evaluations: retention, postoperative sensitivity, secondary caries, colour match, anatomical form, marginal discoloration, marginal adaptation, and surface texture. This clinical assessment method results in ordinally structured data for the outcome variables (A, Alpha = excellent result; B, Bravo = acceptable result; C, Charlie = unacceptable, replacement of the restoration necessary).
次要结局
未报告次要终点
