Accuracy of Standard vs Geometric Pattern-Assisted Digital Scanning Techniques for Construction of Full Arch Implant Prosthesis Framework: A Crossover Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Mean 3D deviation (in microns) between test and reference scans using digital superimposition.
研究概览
简要总结
This clinical trial aims to compare three different impression techniques used to fabricate full-arch implant-supported dental prostheses. Accurate impressions are essential to ensure a passive and precise fit of the final prosthetic framework, which contributes to long-term implant success and patient comfort.
In this crossover study, participants with four osseointegrated dental implants in the lower jaw will undergo three types of impressions:
Conventional splinted impression using polyvinyl siloxane (PVS) material.
Standard digital impression using an intraoral scanner.
Geometric pattern-assisted digital impression, which incorporates a visual reference pattern to improve scan alignment and accuracy.
Each participant will receive all three impression techniques in a randomized sequence, at different time points. The accuracy of each method will be assessed by evaluating the passivity of the resulting prosthetic frameworks using two methods: (1) digital superimposition analysis to measure three-dimensional (3D) spatial deviation, and (2) the clinical "one-screw test" to detect misfit.
The study seeks to determine whether digital scanning, particularly with geometric pattern assistance, can provide accuracy comparable to or better than conventional methods. Findings may guide improvements in digital prosthodontic workflows and support more efficient, predictable treatment outcomes.
详细描述
This is a prospective, crossover clinical trial designed to evaluate and compare the accuracy of three different impression techniques used in the fabrication of full-arch implant-supported prosthesis frameworks. The study includes four participants, each with four osseointegrated dental implants in the mandibular arch.
The three impression techniques being compared are:
Conventional Splinted Impressions: A traditional method utilizing rigidly splinted impression copings and polyvinyl siloxane (PVS) impression material to capture implant positions.
Standard Digital Scanning: A fully digital technique using an intraoral scanner and scan bodies placed on the implants to generate a digital impression.
Geometric Pattern-Assisted Digital Scanning: An enhanced digital method incorporating a geometric reference pattern during the scanning process to improve stitching accuracy and reduce scan distortion across the arch.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 30 to 70 years
- •Completely edentulous mandible
- •Presence of four osseointegrated implants in the lower jaw
- •Good oral and general health
- •Willingness to participate and provide written informed consent
- •Availability for all study appointments
排除标准
- •Systemic diseases or conditions that affect bone healing or implant integration
- •Presence of oral inflammation, infection, or soft tissue abnormalities at implant sites
- •History of bruxism or parafunctional habits
- •Inability to understand or comply with study procedures
研究组 & 干预措施
Conventional Splinted Impression
Participants will undergo a conventional impression technique using open-tray impression copings rigidly splinted with DuraLay resin. The impression is taken using polyvinyl siloxane (PVS) material in a custom tray. This method serves as the control for comparison with digital techniques.
干预措施: Conventional Splinted Impression Technique (Procedure)
Standard Digital Scan
Participants will undergo a full-arch digital scan using an intraoral scanner. Scan bodies will be attached to the multi-unit abutments, and the scan will be performed without any additional geometric reference aids.
干预措施: Intraoral Scanner - Standard Protocol (Device)
Geometric Pattern-Assisted Digital Scan
Participants will undergo a full-arch digital scan using an intraoral scanner, with the addition of a geometric reference pattern placed in the scanning field to improve stitching accuracy and scan reliability.
干预措施: Intraoral Scanner with Geometric Reference Pattern (Device)
结局指标
主要结局
Mean 3D deviation (in microns) between test and reference scans using digital superimposition.
时间窗: Immediately after each impression session (Day 0 for each method).
Accuracy will be assessed by digitally superimposing the scan obtained from each method (conventional splinted impression, standard digital scan, geometric pattern-assisted digital scan) onto a reference scan (conventional method). Specialized software will calculate the mean 3D deviation in microns to quantify spatial accuracy. Lower deviation indicates higher accuracy.
次要结局
- Number of frameworks exhibiting passive fit as determined by the one-screw test.(Within 1 hour of framework placement following each impression method.)
研究者
Mirna ashraf anis heneen
Assistant Lecturer of Prosthodontics, Horus University, Damietta - PhD Candidate, Mansoura University
Mansoura University