Accuracy of Standard and Geometric Pattern-Assisted Digital Scanning for Full-Arch Implant Prosthesis Frameworks

NCT07065487 | Recruiting

• 1 other identifier: MU-PROS-2025-001
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial aims to compare three different impression techniques used to fabricate full-arch implant-supported dental prostheses. Accurate impressions are essential to ensure a passive and precise fit of the final prosthetic framework, which contributes to long-term implant success and patient comfort. In this crossover study, participants with four osseointegrated dental implants in the lower jaw will undergo three types of impressions: Conventional splinted impression using polyvinyl siloxane (PVS) material. Standard digital impression using an intraoral scanner. Geometric pattern-assisted digital impression, which incorporates a visual reference pattern to improve scan alignment and accuracy. Each participant will receive all three impression techniques in a randomized sequence, at different time points. The accuracy of each method will be assessed by evaluating the passivity of the resulting prosthetic frameworks using two methods: (1) digital superimposition analysis to measure three-dimensional (3D) spatial deviation, and (2) the clinical "one-screw test" to detect misfit. The study seeks to determine whether digital scanning, particularly with geometric pattern assistance, can provide accuracy comparable to or better than conventional methods. Findings may guide improvements in digital prosthodontic workflows and support more efficient, predictable treatment outcomes.

Conditions

Edentulous Jaw; Dental Prosthesis, Implant-Supported; Prosthodontics; Dental Implantation, Endosseous

Keywords

Digital impression; Full-arch implant; Geometric pattern; Prosthesis framework; Intraoral scanner; Splinted impression; CAD/CAM prosthodontics; Passive fit; Dental implants

Outcome Measures

Primary Outcomes (1)

• Mean 3D deviation (in microns) between test and reference scans using digital superimposition.

  Accuracy will be assessed by digitally superimposing the scan obtained from each method (conventional splinted impression, standard digital scan, geometric pattern-assisted digital scan) onto a reference scan (conventional method). Specialized software will calculate the mean 3D deviation in microns to quantify spatial accuracy. Lower deviation indicates higher accuracy.

  Immediately after each impression session (Day 0 for each method).

Secondary Outcomes (1)

• Number of frameworks exhibiting passive fit as determined by the one-screw test.

  Within 1 hour of framework placement following each impression method.

Study Arms (3)

Conventional Splinted Impression

EXPERIMENTAL

Participants will undergo a conventional impression technique using open-tray impression copings rigidly splinted with DuraLay resin. The impression is taken using polyvinyl siloxane (PVS) material in a custom tray. This method serves as the control for comparison with digital techniques.

Procedure: Conventional Splinted Impression Technique

Standard Digital Scan

EXPERIMENTAL

Participants will undergo a full-arch digital scan using an intraoral scanner. Scan bodies will be attached to the multi-unit abutments, and the scan will be performed without any additional geometric reference aids.

Device: Intraoral Scanner - Standard Protocol

Geometric Pattern-Assisted Digital Scan

EXPERIMENTAL

Participants will undergo a full-arch digital scan using an intraoral scanner, with the addition of a geometric reference pattern placed in the scanning field to improve stitching accuracy and scan reliability.

Device: Intraoral Scanner with Geometric Reference Pattern

Interventions

Intraoral Scanner - Standard Protocol DEVICE

A full-arch digital impression is obtained using a high-precision intraoral scanner. Scan bodies are placed on multi-unit abutments and scanned without the use of external reference markers or geometric aids. The scan follows the manufacturer-recommended scanning path to capture the complete arch. This serves as a baseline digital technique for comparison with geometric pattern-assisted scanning.

Standard Digital Scan

Intraoral Scanner with Geometric Reference Pattern DEVICE

The same intraoral scanner is used, but with an additional geometric reference pattern introduced in the scanning field to improve stitching accuracy and alignment of the digital scan.

Geometric Pattern-Assisted Digital Scan

Conventional Splinted Impression Technique PROCEDURE

A physical impression is taken using open-tray impression copings splinted with DuraLay resin and polyvinyl siloxane (PVS) material in a custom tray, according to conventional protocols for full-arch implant prostheses.

Conventional Splinted Impression

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 30 to 70 years
• Completely edentulous mandible
• Presence of four osseointegrated implants in the lower jaw
• Good oral and general health
• Willingness to participate and provide written informed consent
• Availability for all study appointments

You may not qualify if:

• Systemic diseases or conditions that affect bone healing or implant integration
• Presence of oral inflammation, infection, or soft tissue abnormalities at implant sites
• History of bruxism or parafunctional habits
• Inability to understand or comply with study procedures

Sponsors & Collaborators

• Mirna ashraf anis heneen: lead

Study Sites (1)

Mansoura University

Al Mansurah, Dakahlia Governorate, 35516, Egypt

RECRUITING

MeSH Terms

Conditions

Jaw, Edentulous

Condition Hierarchy (Ancestors)

Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth, Edentulous; Mouth Diseases; Tooth Diseases

Central Study Contacts

Mirna A. Anis

CONTACT

+20502522062; mirnaashraf01@gmail.com

Khaled M. Zahran

CONTACT

20 50 2200150

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Lecturer of Prosthodontics, Horus University, Damietta - PhD Candidate, Mansoura University

Model Details: randomized crossover clinical trial

Study Record Dates

• First Submitted: June 20, 2025
• First Posted: July 15, 2025
• Study Start: September 30, 2025
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: July 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Beginning 6 months after publication of the study results and for up to 5 years.
• Access Criteria: De-identified individual participant data (IPD) and supporting materials (study protocol, statistical analysis plan, and informed consent form) will be available to qualified researchers affiliated with academic institutions or non-profit organizations. Access will be granted for non-commercial, ethically approved research purposes. Interested researchers must submit a formal request to the Principal Investigator via email, including a research proposal and institutional ethical approval. Access will be provided through secure, password-protected file sharing platforms.

Locations

EG (1)