An interventional study of IO-Connect Digital Impression and Reverse Scan Body Digital Impression in Dental Implants, Edentulous Jaw and Passive Fit, sponsored by Mansoura University. Recruiting at 1 site in Egypt. Open to participants aged 35 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by Mansoura University · Not applicable, Interventional, and Treatment
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.
Full-arch implant-supported fixed prostheses require a high degree of passive fit to avoid mechanical and biological complications. While digital impression workflows are increasingly used as alternatives to conventional splinted impressions, evidence directly comparing their clinical accuracy for complete-arch implant frameworks remains limited, particularly for the IO-Connect non-calibrated splinting system and the Reverse Scan Body technique.
Eight completely edentulous patients with at least four mandibular implants will be enrolled. Using a crossover design, each patient will undergo all three impression techniques: Group I (IO-Connect splinted scan bodies), Group II (Reverse Scan Body technique), and Group III (conventional splinted open-tray impression with polyvinyl siloxane and Type IV stone casts). For each technique, a corresponding implant-supported framework will be fabricated and evaluated for passivity of fit using the Sheffield one-screw test and periapical radiographs taken with a paralleling device to assess microgaps at the implant-framework interface.
122 studies on the registry are indexed under Jaw, Edentulous; 20 are open to participants now.
This study's planned enrollment of 8 is below the median of 24 across 99 interventional studies indexed under Jaw, Edentulous.
Browse Jaw, Edentulous studies →Mansoura University is the lead sponsor of 1,119 studies on the registry; 183 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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Immunosuppression
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Patients received complete-arch implant-supported frameworks fabricated using digital impressions obtained with IO-Connect non-calibrated splinted scan bodies.
Procedure: IO-Connect Digital Impression
Patients received complete-arch implant-supported frameworks fabricated using digital impressions obtained with the Reverse Scan Body (RSB) technique.
Procedure: Reverse Scan Body Digital Impression
Patients received complete-arch implant-supported frameworks fabricated using a conventional splinted open-tray impression technique.
Procedure: Conventional Splinted Impression
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.
Conventional splinted open-tray impression using polyvinyl siloxane material and Type IV dental stone to fabricate the implant-supported framework for Group III.
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.
Time frame: 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.
Time frame: 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.
Plan to share: Undecided
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Started Jan 2026 (actual). Primary completion is estimated for Oct 2026, 9 months after the start.
Of 58 non-industry interventional studies with no phase under Jaw, Edentulous, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 30. This study's planned 9 months is below that.
Counting every sponsor, half of 66 studies reached it within 20 months; a quarter within 12 and three quarters within 38.
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