Passive Fit of Implant-Supported Frameworks: Digital vs Conventional Impressions
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-70
SponsorMansoura University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Completely edentulous patients requiring full-arch implant-supported fixed prosthesis
Age 35-70 years
Adequate mandibular bone to place at least four implants without major grafting
Ability to undergo digital scanning and radiographic evaluation
Disqualifiers
Systemic conditions affecting healing (uncontrolled diabetes, immunosuppression)
History of head/neck radiotherapy or bisphosphonate therapy
Active oral infection or severe bruxism
Strong gag reflex preventing accurate scanning
Trial design
Design model
Crossover
Treatments tested in this trial
IO-Connect Digital Impression
Procedure/SurgeryDigital impression of the mandibular arch obtained using IO-Connect non-calibrated splinted scan bodies to fabricate the implant-supported framework for Group I.
Reverse Scan Body Digital Impression
Procedure/SurgeryDigital 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 Impression
Procedure/SurgeryConventional splinted open-tray impression using polyvinyl siloxane material and Type IV dental stone to fabricate the implant-supported framework for Group III.
Treatment groups
8 Participants
are divided into 3 treatment groupsGroup A: Group I: IO-ConnectActive comparator 1 intervention
Group B: Group II: Reverse Scan BodyActive comparator 1 intervention
Group C: Group III: Conventional ImpressionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.2
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.Sponsors and contacts
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Source ClinicalTrials.gov