Accuracy of the Calibrated Framework for Intra Oral Full Arch Scan (A Cross-over Study)

NCT07858682 | Recruiting

• 1 other identifier: MS.26.01.135
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This crossover clinical trial aims to compare the accuracy of conventional splinted open-tray implant impressions with intraoral digital scanning using a calibrated framework in completely edentulous patients rehabilitated with full-arch implant-supported prostheses. Accurate transfer of implant positions is essential for achieving a passive fit of the prosthetic framework and minimizing biological and mechanical complications. Twenty healthy completely edentulous patients requiring full-arch implant rehabilitation will be enrolled. Each participant will undergo both conventional and digital impression techniques following implant placement, allowing direct within-subject comparison. The conventional technique consists of a verified splinted open-tray impression, while the digital technique uses an intraoral scanner in combination with a calibrated stock framework. The accuracy of the two impression techniques will be evaluated by superimposing the resulting STL files using Geomagic Control X software. Linear deviations in the x-, y-, and z-axes, angular deviations, and global deviations will be measured and compared. The findings of this study are expected to provide clinical evidence regarding the accuracy of calibrated framework-assisted intraoral scanning compared with the conventional impression technique for full-arch implant rehabilitation.

Conditions

Edentulism; Dental Implants

Keywords

Calibrated Framework Implant Impression Accuracy; CAD/CAM; Implant Impression Accuracy; Dentistry

Outcome Measures

Primary Outcomes (1)

• Implant Position Transfer Accuracy (Linear deviations)

  by superimposing STL files obtained from the conventional splinted open-tray impression and intraoral digital scanning using a calibrated framework with Geomagic Control X software. Linear deviations (x-, y-, and z-axes)

  Immediately after impression procedures following implant placement (same study visit).

Secondary Outcomes (1)

• Implant Position Transfer Accuracy (Angular deviations)

  Immediately after impression procedures following implant placement (same study visit).

Study Arms (2)

Conventional Splinted Open-Tray Impression

ACTIVE COMPARATOR

Participants will undergo a conventional verified splinted open-tray implant impression following implant placement. Impression copings will be splinted using dental floss and autopolymerizing resin, and a polyvinyl siloxane (PVS) impression will be made. The resulting master cast will be digitized using a laboratory scanner to generate an STL file for accuracy assessment.

Other: Conventional Splinted Open-Tray Implant Impression

Intraoral Digital Scanning with Calibrated Framework

EXPERIMENTAL

Participants will undergo intraoral digital scanning using an intraoral scanner and a calibrated stock framework attached to implant scan bodies after implant placement. The generated STL file will be compared with the conventional impression using Geomagic Control X software to evaluate transfer accuracy.

Other: Intraoral Digital Scanning Using a Calibrated Framework

Interventions

Conventional Splinted Open-Tray Implant Impression OTHER

A conventional verified splinted open-tray implant impression will be performed after implant placement. Multi-unit impression copings will be splinted using dental floss and autopolymerizing resin, followed by a polyvinyl siloxane (PVS) impression. The master cast will be fabricated, verified, and scanned with a laboratory scanner to generate an STL file for accuracy analysis.

Also known as: Conventional Implant Impression Open-Tray Impression Splinted Open-Tray Technique

Conventional Splinted Open-Tray Impression

Intraoral Digital Scanning Using a Calibrated Framework OTHER

An intraoral digital impression will be obtained after implant placement using an intraoral scanner and a calibrated stock framework attached to implant scan bodies. The resulting STL dataset will be compared with the conventional impression using Geomagic Control X software to evaluate linear, angular, and global deviations in implant position transfer accuracy.

Also known as: Calibrated Framework Technique Intraoral Digital Impression Full-Arch Intraoral Scanning

Intraoral Digital Scanning with Calibrated Framework

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adults aged 18 years or older.
• Completely edentulous maxilla and mandible for at least 6 months following the last tooth extraction.
• Angle's Class I maxillomandibular relationship with adequate interarch space.
• Sufficient residual alveolar bone quantity and quality to receive dental implants.
• Good oral hygiene.
• Free from uncontrolled systemic diseases or conditions that may interfere with implant osseointegration.
• Able and willing to provide written informed consent.

You may not qualify if:

• Temporomandibular joint disorders or parafunctional habits.
• Heavy smokers.
• Uncontrolled systemic diseases.
• History of chemotherapy or radiotherapy to the head and neck region.
• Poor neuromuscular coordination.
• Localized bone defects that could compromise implant placement.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Noor Alhuda Rahemm Khalil

Al Mansurah, 12345, Egypt

RECRUITING

Study Officials

• osama asker, PHD

  Mansoura University

  STUDY CHAIR

Central Study Contacts

noor alhuda raheem, BDS

CONTACT

01044487126; nooralkhalil95@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessment will be performed by comparing STL datasets using Geomagic Control X software. The outcome assessor will be blinded to the impression technique whenever feasible.
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: Each participant will undergo both conventional splinted open-tray impression and intraoral digital scanning using a calibrated framework after implant placement. The accuracy of both techniques will be compared within the same participant.

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: October 5, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: October 5, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)