Accuracy of Complete-arch Implant Scans Obtained Using (TruAbutment,Marker)T-Marker Obtained With a Mobile Phone and Tablet: A Randomized Crossover Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Angular deviation of complete-arch implant scans
研究概览
简要总结
This randomized crossover clinical study will evaluate and compare the accuracy and effective scanning time of complete-arch implant scans obtained using the (TruAbutment,Marker) T-Marker photogrammetry application operated on a smartphone and a tablet. Twenty-four patients with completely edentulous arches rehabilitated with four well-integrated implants connected to multiunit abutments will undergo both digital impression protocols in a randomized sequence. A verified conventional implant cast will serve as the reference standard. Linear and angular deviations between the implant positions obtained using each digital protocol and the reference model will be evaluated using three-dimensional analysis software. Effective scanning time required for implant coordinate acquisition and registration will also be recorded. The study will determine whether the use of T-Marker with a smartphone provides accuracy and scanning efficiency comparable to its use with a tablet.
详细描述
Complete-arch implant scanning is challenging because of the large interimplant distances and the limited availability of stable anatomical landmarks, which may result in cumulative image-stitching errors. Photogrammetry-based workflows have been introduced to improve the accuracy of implant position recording. T-Marker is a photogrammetry application that uses external optical markers and image-acquisition protocols to determine implant positions.
This randomized crossover clinical study will compare two T-Marker acquisition devices: a smartphone and a tablet. Each participant will undergo both digital impression protocols, with the order of the protocols randomized to minimize potential order and operator-learning effects.
A verified conventional splinted implant impression will be used to fabricate a master cast, which will be digitized using a calibrated laboratory scanner to generate the reference dataset. T-Marker optical markers will then be attached to the multiunit abutments, and complete-arch implant position data will be acquired using either an iPhone 15 Pro Max or a tablet. The resulting digital datasets will be compared with the reference dataset using three-dimensional analysis software.
Linear and angular deviations will be evaluated to determine the trueness of the implant position measurements. Effective scanning time, defined as the time required to acquire and register all implant positions using the photogrammetric acquisition mode, will also be recorded. Surface and soft-tissue scanning, STL export, and data-merging procedures will not be included in the scanning-time measurement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
盲法说明
No participants, care providers, investigators, or outcome assessors will be masked to the digital impression device used.
入排标准
- 年龄范围
- 40 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •Adults aged 40-60
- •Completely edentulous maxillary arch.
- •Four well-integrated dental implants connected to multiunit abutments.
- •Implants positioned in the right and left canine and molar regions.
- •Presence of a screw-retained interim implant-supported prosthesis or need for definitive implant-supported prosthetic rehabilitation.
- •Willingness to provide written informed consent.
排除标准
- •Fewer than four implants.
- •Implants placed in the mandibular arch.
- •Failed implants.
- •Active peri-implant infection or suppuration
研究组 & 干预措施
T-Marker With Smartphone
Participants undergo complete-arch implant scanning using T-Marker optical markers attached to the multiunit abutments and a smartphone-based photogrammetry workflow.
干预措施: Smartphone (Device)
T-Marker With Smartphone
Participants undergo complete-arch implant scanning using T-Marker optical markers attached to the multiunit abutments and a smartphone-based photogrammetry workflow.
干预措施: Tablet (Device)
T-Marker With Tablet
Participants undergo complete-arch implant scanning using T-Marker optical markers attached to the multiunit abutments and a Tablet-based photogrammetry workflow.
干预措施: Smartphone (Device)
T-Marker With Tablet
Participants undergo complete-arch implant scanning using T-Marker optical markers attached to the multiunit abutments and a Tablet-based photogrammetry workflow.
干预措施: Tablet (Device)
结局指标
主要结局
Angular deviation of complete-arch implant scans
时间窗: Immediately after each digital impression procedure
Angular deviation of the implant positions obtained using T-Marker photogrammetry with a smartphone or tablet, compared with the reference implant positions obtained from the verified conventional splinted impression. Angular deviation will be measured in degrees using three-dimensional inspection software.
次要结局
- Linear deviation of complete-arch implant scans(Immediately after each digital impression procedure)
研究者
Mohammed El-Sawy
Senior Lecturer of Prosthodontics
Menoufia University
