NCT07370701

Brief Summary

Statement of the problem: Accurate digital scans of edentulous patients is challenging due to the absence of anatomic landmarks and geometric variations along the dental arch. Whether adding an auxiliary geometric device (AGD) will improve scanning is unclear. Purpose: The aim of the study is to analyze the accuracy of complete-arch digital scans of completely edentulous arches by placing auxiliary geometric device. Material and Methods: This in vivo study included patients who received complete arch screw-retained prostheses supported by 4 implants. Seven patients were randomly chosen; a dual scan protocol was performed for digital implant planning. Surgical guide and AGD were 3d printed. Three different data acquisition methods for each individual: Open tray impression digitized by extraoral scanner (EO Group), Intraoral scan by using Medit i600 with AGD (M600 Group), and Intraoral scan (CEREC Primescan; Dentsply Sirona) with AGD (PS Group). A reference model was formed to check the accuracy of these 3 data acquisitions. The framework was designed and printed for the 3 groups to be placed in the reference model to check the passivity. Passivity was tested through modified 1-screw test by measuring the marginal gap by using a digital camera (add magnification). Each framework was placed in the patient's mouth to re-check the passivity, the best one was delivered to the patient after 4 months after osteointegration of the implants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2023

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 8, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 27, 2026

Completed
Last Updated

January 27, 2026

Status Verified

January 1, 2026

Enrollment Period

1.7 years

First QC Date

January 13, 2026

Last Update Submit

January 21, 2026

Conditions

Passivity of Co-Cr Full-arch Maxillary Prostheses Via IOS

Keywords

intraoral scannerAuxiliary geometric deviceAll on 4 maxillamodified screw test

Outcome Measures

Primary Outcomes (1)

  • estimate the marginal gap using digital camera

    modified single screw test to check the passivity of the 3 frameworks in both the models and in the patient's mouth by radiograph

    after 4 months after osteointegration of the implants

Study Arms (3)

Open tray impression digitized by extraoral scanner (EO Group)

EXPERIMENTAL

A reference model was formed to check the accuracy of these 3 data acquisitions. The framework was designed and printed for the 3 groups to be placed in the reference model to check the passivity. Passivity was tested through modified 1-screw test by measuring the marginal gap by using a digital camera (add magnification). Each framework was placed in the patient's mouth to re-check the passivity, the best one was delivered to the patient after 4 months after osteointegration of the implants.

Other: Open tray impression technique

Intraoral scan by using Medit i600 with AGD (M600 Group)

EXPERIMENTAL

A reference model was formed to check the accuracy of these 3 data acquisitions. The framework was designed and printed for the 3 groups to be placed in the reference model to check the passivity. Passivity was tested through modified 1-screw test by measuring the marginal gap by using a digital camera (add magnification). Each framework was placed in the patient's mouth to re-check the passivity, the best one was delivered to the patient after 4 months after osteointegration of the implants.

Other: Auxiliary Geometric Device (M600)

Intraoral scan (CEREC Primescan; Dentsply Sirona) with AGD (PS Group)

EXPERIMENTAL

A reference model was formed to check the accuracy of these 3 data acquisitions. The framework was designed and printed for the 3 groups to be placed in the reference model to check the passivity. Passivity was tested through modified 1-screw test by measuring the marginal gap by using a digital camera (add magnification). Each framework was placed in the patient's mouth to re-check the passivity, the best one was delivered to the patient after 4 months after osteointegration of the implants.

Other: Auxiliary Geometric Device (PS)

Interventions

Open tray impression techniqueOTHER

dental implant then open tray impression technique

Open tray impression digitized by extraoral scanner (EO Group)
Auxiliary Geometric Device (M600)OTHER

analyze the accuracy and passivity of complete-arch digital scans of completely edentulous arches by placing auxiliary geometric device

Intraoral scan by using Medit i600 with AGD (M600 Group)
Auxiliary Geometric Device (PS)OTHER

analyze the accuracy and passivity of complete-arch digital scans of completely edentulous arches by placing auxiliary geometric device

Intraoral scan (CEREC Primescan; Dentsply Sirona) with AGD (PS Group)

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • For a maxillary edentulous patient, the last extraction should be at least six months
  • Non-smokers
  • years of age
  • Have good oral hygiene and motivation.

You may not qualify if:

  • Patients with major systemic diseases that may affect osseointegration
  • Uncontrolled diabetes mellitus
  • The need for extensive bone grafting in the planned implant site
  • Pregnant female patient
  • Under bisphosphonate treatment
  • Limited mouth-opening for executing the guided implant surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Ain Shams University

Cairo, Organization of African Unity Street,, 02, Egypt

Location

Related Links

Study Officials

  • Yasmin H Abd El Hay Dawoud

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer of Oral and Maxillofacial Prosthodontics

Study Record Dates

First Submitted

January 13, 2026

First Posted

January 27, 2026

Study Start

June 8, 2023

Primary Completion

March 5, 2025

Study Completion

September 5, 2025

Last Updated

January 27, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)