NCT07211022

Brief Summary

This clinical trial evaluates the accuracy of two digital impression techniques intraoral photogrammetry and intraoral scanning in patients rehabilitated with full-arch implant-supported prostheses (All-on-4 and All-on-6 concepts).

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 7, 2025

Completed
18 days until next milestone

Study Start

First participant enrolled

October 25, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2026

Completed
Last Updated

February 10, 2026

Status Verified

February 1, 2026

Enrollment Period

3 months

First QC Date

September 30, 2025

Last Update Submit

February 7, 2026

Conditions

Complete Edentulism

Keywords

digital impressionphotogrammetryIntraoral scanning

Outcome Measures

Primary Outcomes (1)

  • Digital impressions of all the enrolled patients

    STL files of digital impressions, intraoral scanning and photogrammetry , of all the enrolled patients.

    After 3 months from implant placement for all the enrolled patients

Secondary Outcomes (1)

  • Virtual analyses of implant positions

    Within 3 months from digital impression

Study Arms (3)

Intraoral Scanner

ACTIVE COMPARATOR

Digital scanning of edentulous arches using intraoral scanner (Aoralscan Elite, Shining 3D)

Procedure: Digital impression using intraoral scanner

Intraoral Photogrammetry

ACTIVE COMPARATOR

Digital scanning of edentulous arches using intraoral photogrammetry (Aoralscan Elite, Shining 3D)

Procedure: Digital impression using intraoral photogrammetry

Conventional impression of edentulous arches

ACTIVE COMPARATOR

Conventional impression of complete- arch edentulous patients

Procedure: Conventional impression

Interventions

Digital impression using intraoral scannerPROCEDURE

Digital impression of complete- arch edentulous patients using intraoral scanner

Intraoral Scanner
Digital impression using intraoral photogrammetryPROCEDURE

Digital impression of complete-arch edentulous patients using intraoral photogrammetry

Intraoral Photogrammetry
Conventional impressionPROCEDURE

Conventional impression of complete-arch edentulous patients

Conventional impression of edentulous arches

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults ≥18 years
  • Edentulous maxilla or mandible
  • All-on-4 or All-on-6 implant supported restoration
  • Ability to provide informed consent

You may not qualify if:

  • Severe systemic diseases (ASA III+)
  • Bisphosphonate therapy
  • Heavy bruxism
  • Inability to attend follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Dental Clinic of Aldent University

Tirana, Albania, 1017, Albania

Location

Related Links

Study Officials

  • Brunilda Koci, Assoc. Prof.

    Aldent University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: This is a cross over in vivo clinical study in which each participant will undergo both digital impressions IOS and Intraoral Photogrammetry , using conventional impression technique as reference.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2025

First Posted

October 7, 2025

Study Start

October 25, 2025

Primary Completion

January 25, 2026

Study Completion

March 25, 2026

Last Updated

February 10, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

Study Protocol

Shared Documents
STUDY PROTOCOL
Time Frame
The full study protocol will be made available beginning 1 year after publication of the primary results in a peer-reviewed journal and ending 2 years after the publication of results.
Access Criteria
The full study protocol will be shared upon reasonable request to qualified researchers . Requests should be submitted to the principal investigator via institutional email. Data will be provided after approval of the proposal and completion of a data agreement to ensure appropriate use of the data. Shared files will be transmitted through a secure institutional repository.

Locations

AL(1)