NCT07106177

Brief Summary

The aim of this study is to assess the three-dimensional accuracy of direct intraoral scanning in All-on-4 implant-supported prostheses by comparing intraoral scan data with a custom-made verification jig.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
completed

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

June 3, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2025

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

July 22, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 6, 2025

Completed
Last Updated

August 6, 2025

Status Verified

August 1, 2025

Enrollment Period

1.1 years

First QC Date

July 22, 2025

Last Update Submit

August 3, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Vertical Deviation

    Analogues Saved from the Intraoral scan and those saved from stone model were superimposed. The vertical discrepancy (mm) in implant position between intraoral digital scanning and verification jig-based stone model in All-on-4 implant cases.

    through study completion, an average of 1 year

  • Angular deviation

    Analogues Saved from the Intraoral scan and those saved from stone model were superimposed. The angular difference (degrees) in implant position between intraoral digital scanning and verification jig-based stone model in All-on-4 implant cases.

    through study completion, an average of 1 year

  • Horizontal deviation

    Analogues Saved from the Intraoral scan and those saved from stone model were superimposed. The horizontal discrepancy (mm) in implant position between intraoral digital scanning and verification jig-based stone model in All-on-4 implant cases.

    through study completion, an average of 1 year

Study Arms (2)

Scanning with the aid of jig

EXPERIMENTAL
Other: Scanning with verification jig

Scanning without jig

ACTIVE COMPARATOR
Other: Direct intraoral scanning

Interventions

Comparing Relative Implant Positions of the 4 implants in each case obtained through desktop scanning of intraoral provisional verification jig. All-on-4 treatment for mandibular and maxillary edentulous cases were scanned using the Medit i700 intraoral scanner. Scan data were imported into Exocad software, where scan-body matching was performed using the Neodent library to determine the positions of multiunit abutment analogues.

Scanning with the aid of jig

Comparing Relative Implant Positions of the 4 implants in each case obtained through direct intraoral scanning without jig. All-on-4 treatment for mandibular and maxillary edentulous cases were scanned using the Medit i700 intraoral scanner. Scan data were imported into Exocad software, where scan-body matching was performed using the Neodent library to determine the positions of multiunit abutment analogues.

Scanning without jig

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with complete mandibular edentulism.
  • Patients requiring full-arch rehabilitation with an All-on-4 implant concept.
  • Absence of systemic conditions that could affect bone healing or osseointegration.
  • Adequate bone volume in the anterior mandible for implant placement without the need for additional grafting.
  • Patients capable of maintaining oral hygiene

You may not qualify if:

  • Patients with uncontrolled systemic diseases (e.g., diabetes, osteoporosis).
  • History of head and neck radiation therapy.
  • Severe parafunctional habits (e.g., bruxism).
  • Patients with inadequate bone volume requiring extensive grafting procedures.
  • Active periodontal or oral infections.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor of Fixed Prosthodontics

Study Record Dates

First Submitted

July 22, 2025

First Posted

August 6, 2025

Study Start

June 3, 2024

Primary Completion

July 10, 2025

Study Completion

July 10, 2025

Last Updated

August 6, 2025

Record last verified: 2025-08

Locations