Complete Edentulism, Dental Prosthesis, Implant-Supported, Full Arch Implant Rehabilitation, Prosthodontics
Conditions
Keywords
Intraoral Scanner, Digital impression, Passive fit, Auxiliary Geometric Device, Fixed Detachable Prosthesis, Implant Scan Body, Full-arch implant, horizontal scan body
Brief summary
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.
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: 1. Splinted Scan Bodies: Implant scan bodies will be splinted using composite resin before intraoral scanning. 2. Horizontal Non-Calibrated Scan Bodies (IO Connect): Digital impressions will be obtained using the IO Connect horizontal scan body system. 3. 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.
Interventions
DEVICESplinted Scan Body with composite
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.
DEVICEIO Connect Scanning Technique
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.
DEVICEAuxiliary Geometric Device Scanning Technique
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.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
Each participant will undergo all three intraoral scanning techniques in a randomized sequence. The three scanning techniques include splinted scan bodies, horizontal non-calibrated scan bodies (IO Connect), and auxiliary geometric devices. The crossover design allows within-subject comparison of scanning accuracy and passive fit while minimizing inter-participant variability.
Eligibility
Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. Completely edentulous patients with age between 40-60 years. 2. Adequate bone height to fulfill the criteria for implant placement. 3. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implant linear and angular deviation | 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 |
| Three-Dimensional part comparison | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| fit of verification jig | 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. |
Countries
Egypt
Contacts
CONTACTMostafa Hamed Mostafa Abd El-Hameed Abd El-Hameed, BDS, MSc
PRINCIPAL_INVESTIGATORMostafa Hamed Mostafa Abd El-Hameed Abd El-Hameed, BDS, MSc
Faculty of Dentistry, Tanta University, Egypt
Outcome results
None listed