NCT07320729

Brief Summary

This prospective in vivo clinical trial evaluates and compares the accuracy (trueness) and scanning time of intraoral photogrammetry scanners (IPS) versus conventional intraoral optical scanners (IOS) for immediate full-arch implant impressions. The reference standard will be a verified conventional splinted open-tray impression taken at the uncovering stage. Sixty edentulous arches receiving 4-6 implants will be included. Linear, angular, and 3D Euclidean deviations will be calculated to assess accuracy.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 7, 2025

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

December 21, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 6, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

January 6, 2026

Status Verified

December 1, 2025

Enrollment Period

5 months

First QC Date

December 21, 2025

Last Update Submit

December 21, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Trueness of Implant Position (3D Euclidean Deviation)

    The primary outcome is to evaluate the clinical performance of conventional intraoral scanners (IOS) and intraoral photogrammetry scanners (IPS) in immediate complete arch implant loading for each patient enrolled in the study, with a paired comparison of the deviation differences (Degree of Trueness).

    3 Months

Secondary Outcomes (1)

  • Effect of Arch Type on Digital Impression Trueness

    3 Months

Study Arms (2)

Intraoral Optical Scanner (IOS)

EXPERIMENTAL

Participants will undergo a digital implant impression using a conventional intraoral optical scanner immediately after implant placement to capture implant positions for immediate full-arch loading.

Device: Intraoral Optical Scanner

Intraoral Photogrammetry Scanner (IPS)

EXPERIMENTAL

Participants will undergo a digital implant impression using an intraoral photogrammetry scanner immediately after implant placement to capture implant coordinates using photogrammetric scan flags combined with intraoral soft tissue scanning.

Device: Intraoral Photogrammetry Scanner Elite (Shining3D)

Interventions

Digital intraoral scanning of implant positions using standard scan bodies for complete-arch implant impressions.

Intraoral Optical Scanner (IOS)

Intraoral photogrammetric capture of implant coordinates using scan flags, combined with soft tissue scanning, without stitching.

Intraoral Photogrammetry Scanner (IPS)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Completely edentulous arch to receive 4-6 implants. Candidate for immediate loading with a one-piece fixed prosthesis. ASA I or II medically healthy patients. Patient able to attend follow-up visits and sign informed consent.

You may not qualify if:

  • Medically compromised patients (ASA III or higher). Poor oral hygiene or heavy smokers. Insufficient bone volume for implant placement. Uncooperative patients or those refusing participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, Asyut Governorate, 71111, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer of Oral Medicine and Periodontology , Assiut University

Study Record Dates

First Submitted

December 21, 2025

First Posted

January 6, 2026

Study Start

December 7, 2025

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

January 6, 2026

Record last verified: 2025-12

Locations