Passive Fit Evaluation of Full-Arch Implant-supported Frameworks Using Digital and Conventional Impression Techniques: Crossover Study
Sponsor study identifier
interventional
8
1 country
1
Study Start
January 25, 2026
Actual (reported)Primary Completion
October 25, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 25, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
This randomized crossover clinical trial compares the passivity of fit of complete-arch mandibular implant-supported frameworks fabricated using three impression techniques: a non-calibrated splinted digital scan body system (IO-Connect), a Reverse Scan Body (RSB) digital impression technique, and a conventional splinted open-tray impression technique. Eight completely edentulous patients each receiving four mandibular implants will be included. Passivity of fit will be evaluated clinically using the Sheffield one-screw test and radiographically using intraoral periapical radiographs obtained with the parallel technique.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 25, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 25, 2026
Actual (reported)August 6, 2026
Actual (reported)August 21, 2026
Actual (reported)October 25, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 25, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Passive Fit Assessed by Sheffield One-Screw Test
The framework was seated on all implants and a single distal screw was fully tightened; remaining screw sites were examined visually and tactilely for lifting, rocking, or gaps as an indicator of passive fit.
The evaluation of passive fit by Sheffield one-screw test will be done 3 months after implant placement (3M-IP), at framework try-in for each of the three impression techniques.
Passive Fit Assessed by Periapical Radiographs
Intraoral periapical radiographs were obtained at each implant site using a paralleling device and evaluated for microgaps at the implant-framework interface.
The evaluation of passive fit by periapical radiographs will be done 3 months after implant placement, at framework try-in for each of the three impression techniques.
Patients received complete-arch implant-supported frameworks fabricated using digital impressions obtained with IO-Connect non-calibrated splinted scan bodies.
Patients received complete-arch implant-supported frameworks fabricated using digital impressions obtained with the Reverse Scan Body (RSB) technique.
Digital impression of the mandibular arch obtained using IO-Connect non-calibrated splinted scan bodies to fabricate the implant-supported framework for Group I.
Digital impression obtained using the Reverse Scan Body (RSB) technique, involving extraoral scanning of scan bodies and superimposition with intraoral tissue scans, to fabricate the implant-supported framework for Group II.
Faculty of Dentistry, Mansoura University
Al Mansurah, Dakahlia Governorate, Egypt
Fatma A El-Waseef, PhD
Mansoura University
First Submitted
August 6, 2026
First Posted
August 21, 2026
Study Start
January 25, 2026
Actual (reported)Patients received complete-arch implant-supported frameworks fabricated using a conventional splinted open-tray impression technique.
Conventional splinted open-tray impression using polyvinyl siloxane material and Type IV dental stone to fabricate the implant-supported framework for Group III.
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Primary Completion
October 25, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 25, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 21, 2026
Record last verified: 2026-08
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Source: ClinicalTrials.gov.
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