Faculty of Dentistry, Tanta University
Tanta, Gharbia Governorate, 31527, Egypt
Location status: Recruiting
Location contact
Mostafa Hamed Mostafa Abd El-Hameed
CONTACT
Mostafa Hamed Mostafa Abd El-Hameed, BDS, MSc
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07740265
This crossover clinical study aims to evaluate the influence of three different intraoral scanning techniques on the scanning accuracy and passive fit of mandibular implant-supported fixed detachable prostheses in completely edentulous patients. Each participant will undergo digital implant scanning using three methods: splinted scan bodies, horizontal non-calibrated scan bodies (IO Connect), and auxiliary geometric devices.
Interested in participating?
Request Info40 year–60 year
All sexes
Interventional
Not applicable
Tanta, Gharbia Governorate, 31527, Egypt
Location status: Recruiting
Mostafa Hamed Mostafa Abd El-Hameed
CONTACT
Mostafa Hamed Mostafa Abd El-Hameed, BDS, MSc
PRINCIPAL_INVESTIGATOR
This prospective crossover clinical trial is designed to evaluate and compare the accuracy and passive fit of three different intraoral scanning techniques used for the fabrication of mandibular implant-supported fixed detachable prostheses in completely edentulous patients.
The study will include completely edentulous participants rehabilitated with four osseointegrated implants placed in the mandibular arch. Each participant will undergo digital implant impression procedures using three different scanning .
The three scanning techniques being compared are:
Digital datasets generated from each scanning technique will be analyzed and compared. Verification jigs will be fabricated using CAD/CAM technology and clinically evaluated.
The primary outcomes of the study are scanning accuracy, assessed by measuring linear deviation (µm) and angular deviation (degrees) between implant positions obtained from the different scanning techniques, and three-dimensional surface deviation analysis, assessed through root mean square (RMS) values and median surface deviation obtained from STL file superimposition.
The secondary outcome is passive fit , which will be evaluated using the Sheffield one-screw test and intraoral periapical radiographic assessment.
The findings of this study will help identify the scanning technique that provides the highest accuracy and best passive fit for mandibular implant-supported fixed detachable prostheses and may contribute to improving digital workflows in complete-arch implant rehabilitation.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
1-. Insufficient vertical inter-arch space to accommodate the restorative components.
A full-arch digital implant impression will be obtained using implant scan bodies splinted with composite resin prior to scanning. The splinting procedure will provide enhanced scan body stability and will be used to minimize positional discrepancies during digital impression acquisition.
A full-arch digital implant impression will be obtained using horizontal non-calibrated scan bodies (IO Connect). The horizontal scan body design will facilitate implant position recognition, digital alignment, and accurate transfer of implant coordinates throughout the digital impression procedure.
A full-arch digital implant impression will be obtained using 3D-printed auxiliary geometric devices attached to implant scan bodies. These auxiliary devices will provide additional geometric reference landmarks to improve stitching accuracy, reduce cumulative scanning errors, and enhance complete-arch digital impression accuracy.
Time frame: Immediately after completion of digital scanning day 0
The linear and angular deviations of implants will be compared and analyzed across different scanning techniques against each other
Time frame: Immediately after completion of digital scanning day 0
Three-dimensional surface deviation will be evaluated by uploading all STL files to dedicated comparison software. Digital superimposition will be performed to calculate the median surface deviation and root mean square (RMS) values between the datasets, providing a quantitative assessment of surface discrepancies among the three scanning techniques.
Time frame: Within 1 hour of fabrication and intraoral placement of the verification jig
Passive fit will be evaluated clinically using the Sheffield one-screw test and confirmed by intraoral periapical radiographs.
Contact information is provided by the study sponsor or research team.
Tanta University
Other
Influence of Three Different Scanning Techniques on Scanning Accuracy for Mandibular Fixed Detachable Prosthesis (A Cross Over Study).
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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