Faculty of Dentistry, Mansoura University
Al Mansurah, Dakahlia Governorate, Egypt
Location status: Recruiting
Location contact
Ahmed H Hazem Elsayed Helmi Atwa, BDS
CONTACT
Ahmed Hazem Elsayed Helmi Atwa, BDS
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07778199
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.
Interested in participating?
Request Info35 year–70 year
All sexes
Interventional
Not applicable
Al Mansurah, Dakahlia Governorate, Egypt
Location status: Recruiting
Ahmed H Hazem Elsayed Helmi Atwa, BDS
CONTACT
Ahmed Hazem Elsayed Helmi Atwa, BDS
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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 periapical radiographs will be done 3 months after implant placement, at framework try-in for each of the three impression techniques.
Intraoral periapical radiographs were obtained at each implant site using a paralleling device and evaluated for microgaps at the implant-framework interface.
Contact information is provided by the study sponsor or research team.
Mansoura University
Other
Passive Fit Evaluation of Full-Arch Implant-supported Frameworks Using Digital and Conventional Impression Techniques: Crossover 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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