Effect of Different Intraoral Scanning Approaches on the Passive Fit of Mandibular All-on-Four Screw-Retained Frameworks
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Clinical assessment of passive fit following the latest update of the one screw test
研究概览
简要总结
Although an intraoral scanner IOS can offer the clinician a completely digital workflow, achieving trustworthy digital scans in edentulous jaws is challenging because of the lack of fixed anatomical landmarks. From this perspective, several methods have been proposed to improve the accuracy of digital scanning, however, related results remain inconclusive, and previously proposed devices have had limitations, such as bulkiness, excessive manufacturing requirements, and poor commercial applicability.
Thus, this study aims to clinically compare the effect of conventional versus photogrammetry intraoral scanning methods on the passive fit of mandibular all-on four screw-retained frameworks.
详细描述
The current study will be designed to be a crossover, double-blinded randomized clinical trial. Eighteen edentulous patients will be selected to share in the study to be rehabilitated by screw-retained prostheses following the all-on-4 protocol. After guided implant surgery, patients will be immediately restored by screw-retained acrylic provisionals following the traditional denture conversion technique. The definitive prosthesis will be fabricated after osseointegration starting with the intraoral scanning procedure; each patient will be subjected to three different scanning methods that can enhance the existing IOS workflow; for group I, the Medit i600 will be used to obtain direct intraoral scans while the scan bodies are combined with extra photogrammetry system scanning assistance, for group II, Medit i600 direct intraoral scans will be obtained while applying basic simple splinting along with incorporating a unique tip in the scanning protocol and scanner software, for group III, Medit i600 direct intraoral classical scans will be obtained while applying only a basic simple splinting. The STL file obtained from the different scans will be sent directly to the dental laboratory and three CAD/Milled frameworks will be realized based on the acquired scans. The jigs' passivity will be tested in the patient's mouth by the single screw test followed by the screw resistance test and the screw resistance test parameter will be calculated. The results will be collected for statistical analysis.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients having a completely edentulous lower arch that could be restored by fixed screw-retained implant prosthesis.
- •Patients having a substantial bone height and width at prospective implant sites to install four standard-size implants following the all-on-4 protocol.
- •Patients having Sufficient crown height space.
排除标准
- •Patients with bad oral hygiene.
- •Patients with limited mouth opening.
- •Vulnerable groups.
- •Uncooperative patients.
- •Patients receiving or undergoing radiotherapy or chemotherapy. Patients with systemic diseases affecting bone metabolism. Smokers.
研究组 & 干预措施
Simple splinting-assisted intraoral scanning
The Medit i600 direct intraoral classical scans will be obtained while applying only a basic simple splinting
干预措施: The Photogrammetry-assisted intraoral scanning (Device)
Simple splinting-assisted intraoral scanning
The Medit i600 direct intraoral classical scans will be obtained while applying only a basic simple splinting
干预措施: The modified approach of splinting-assisted intraoral scanning (Device)
modified splinting-assisted intraoral scanning technique
The Medit i600 direct intraoral scans will be obtained while applying basic simple splinting along with incorporating a unique tip in the scanning protocol and scanner software
干预措施: Simple splinting-assisted intraoral scanning (Device)
Photogrammetry-assisted intraoral scanning
The Medit i600 will be used to obtain direct intraoral scans while the scan bodies are combined with extra photogrammetry system scanning assistance.
干预措施: Simple splinting-assisted intraoral scanning (Device)
结局指标
主要结局
Clinical assessment of passive fit following the latest update of the one screw test
时间窗: six months
Three CAD/Milled frameworks for each subject will be realized based on the acquired scans. The passive fit of each framework will be assessed intraorally following the Sheffield test: The test Part I involves checking the fit of the framework using finger pressure then tightening one of the most distal abutment screws. when an accurate horizontal and perpendicular fit viewed under magnification (will be categorized as 3 or excellent). If a slight "shadow" or suspicion of a vertical discrepancy, exists between the framework and abutment, a satisfactory passive fit will be confirmed by part 2 of test; If a suspected fit discrepancy can be closed using a 13mm wide modelling wax strip, representing 20 KN/m2 pressure load without distorting, then the fit is deemed to be clinically acceptable (categorized as 2 or good). If the wax does distort or is unable to close the discrepancy, will be (categorized as 1 or poor). this categorization arbitrarily defined by authors.
次要结局
- objective assessment of clinical passive fit using the screw resistance test parameter(six months)
研究者
Sara Ibrahim Soliman
lecturer at faculty of dentistry Ain-Shams University
Ain Shams University