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Clinical Trials in Egypt / NCT07778199
Recruiting Not applicable

Passive Fit of Implant-Supported Frameworks: Digital vs Conventional Impressions

NCT07778199 · tracked via the Priya Life Science Egypt tracker
Sponsor
Mansoura University
Phase
Not applicable
Started
2026-01-25
Last updated
2026-08-21

Condition(s) studied

Dental ImplantsEdentulous JawPassive Fit

Investigational drug(s) / intervention(s)

IO-Connect Digital ImpressionReverse Scan Body Digital ImpressionConventional Splinted Impression

IO-Connect Digital 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.

Reverse Scan Body Digital Impression: 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 Impression: Conventional splinted open-tray impression using polyvinyl siloxane material and Type IV dental stone to fabricate the implant-supported framework for Group III.

Study summary

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

Sex
ALL
Min age
35 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: * 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 * Signed informed consent Exclusion Criteria: * 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 * Poor compliance or unwillingness to attend follow-up visits

Primary outcome measure(s)

  • Passive Fit Assessed by Sheffield One-Screw Test — 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.
  • Passive Fit Assessed by Periapical Radiographs — 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.

Trial sites (1)

FacilityCityRegionStatus
Faculty of Dentistry, Mansoura University Al Mansurah Dakahlia Governorate Recruiting

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Titanium Versus Nano-Carbon CAD/CAM Frameworks for All-on-4 Implant Supported Hybrid Prosthesis. Active, not recruiting

Other trials for the same condition

Accuracy of Complete-arch Implant Scans Obtained Using T-Marker Active, not recruiting
Effectiveness of ALB-PRF With Two Types of Bone Grafts With Putty Form Around Immediate Dental Implants. Enrolling by invitation
Comparison Between Two Different Healing Abutments in Single Posterior Implants Active, not recruiting
Marginal Bone Changes in Fixed All-on-Four Mandibular Prosthesis Using OT Bridge Attachment System Recruiting
Accuracy of the Calibrated Framework for Intra Oral Full Arch Scan (A Cross-over Study) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07778199 on ClinicalTrials.gov ↗ ← All trials in Egypt