Effect of Scanning Techniques on Accuracy of Mandibular Fixed Detachable Prostheses
Influence of Three Different Scanning Techniques on Scanning Accuracy for Mandibular Fixed Detachable Prosthesis (A Cross Over Study).
Study Overview
Status
Conditions
Detailed Description
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:
- Splinted Scan Bodies: Implant scan bodies will be splinted using composite resin before intraoral scanning.
- Horizontal Non-Calibrated Scan Bodies (IO Connect): Digital impressions will be obtained using the IO Connect horizontal scan body system.
- Auxiliary Geometric Devices: Digital impressions will be acquired using 3D-printed auxiliary geometric devices attached to the scan bodies to provide additional geometric reference landmarks during scanning.
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mostafa Hamed Mostafa Abd El-Hameed Abd El-Hameed, BDS, MSc
- Phone Number: +201090461713
- Email: mostafa_hamed@dent.tanta.edu.eg
Study Locations
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Gharbia Governorate
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Tanta, Gharbia Governorate, Egypt, 31527
- Recruiting
- faculty of dentistry, Tanta university
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Contact:
- Mostafa Hamed Mostafa Abd El-Hameed
- Phone Number: +201090461713
- Email: mostafa_hamed@dent.tanta.edu.eg
-
Principal Investigator:
- Mostafa Hamed Mostafa Abd El-Hameed, BDS, MSc
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Completely edentulous patients with age between 40-60 years.
- Adequate bone height to fulfill the criteria for implant placement.
- Patients should have a class I Angle's classification.
Exclusion Criteria:
1-. Insufficient vertical inter-arch space to accommodate the restorative components.
2. Presence of psychiatric or neurological conditions. 3. Any systemic diseases that may affect implant bone osteointegration.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Splinted Scan Bodies with composite
Participants will undergo full-arch digital implant scanning using implant scan bodies splinted with composite resin.
The splinting procedure is intended to improve the stability of scan bodies and reduce positional discrepancies during digital impression acquisition.
|
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.
|
|
Experimental: horizontal non-calibrated scan bodies
Participants will undergo full-arch digital implant scanning using horizontal non-calibrated scan bodies (IO Connect).
This technique utilizes a horizontal scan body design to facilitate implant position recognition, digital alignment, and complete-arch 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.
|
|
Experimental: Auxiliary Geometric Device Scanning
Participants will undergo full-arch digital implant scanning using 3D-printed auxiliary geometric devices attached to implant scan bodies.
The auxiliary devices provide additional geometric reference landmarks intended to improve scanning accuracy and reduce stitching errors during complete-arch digital impressions.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Implant linear and angular deviation
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
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Immediately after completion of digital scanning day 0
|
|
Three-Dimensional part comparison
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.
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Immediately after completion of digital scanning day 0
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
fit of verification jig
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.
|
Within 1 hour of fabrication and intraoral placement of the verification jig
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mostafa Hamed Mostafa Abd El-Hameed Abd El-Hameed, BDS, MSc, Faculty of Dentistry, Tanta University, Egypt
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- RP-11-25-3482
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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