Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07778199

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

35 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Mansoura University

Al Mansurah, Dakahlia Governorate, Egypt

Location status: Recruiting

Location contact

Ahmed H Hazem Elsayed Helmi Atwa, BDS

CONTACT

[email protected]

+20 1092758696

Ahmed Hazem Elsayed Helmi Atwa, BDS

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IO-Connect Digital Impression

Procedure

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

Procedure

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

Procedure

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

Primary outcomes

  1. Passive Fit Assessed by Sheffield One-Screw Test

    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.

  2. Passive Fit Assessed by Periapical Radiographs

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed H Hazem Elsayed Helmi Atwa, BDS

CONTACT

[email protected]

+20 1092758696

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Passive Fit Evaluation of Full-Arch Implant-supported Frameworks Using Digital and Conventional Impression Techniques: Crossover Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Aug 21, 2026
Registry last updated
Aug 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

Published trials that share one or more normalized conditions with this study.