NCT07740265

Brief Summary

This crossover clinical study aims to evaluate the influence of three different intraoral scanning techniques on the scanning accuracy and passive fit of mandibular implant-supported fixed detachable prostheses in completely edentulous patients. Each participant will undergo digital implant scanning using three methods: splinted scan bodies, horizontal non-calibrated scan bodies (IO Connect), and auxiliary geometric devices.

Trial Health

77
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
11mo left

Started Aug 2026

Geographic Reach
1 country

1 active site

Status
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

First Submitted

Initial submission to the registry

July 28, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 31, 2026

Completed
8 days until next milestone

Study Start

First participant enrolled

August 8, 2026

Expected
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

July 31, 2026

Status Verified

July 1, 2026

Enrollment Period

8 months

First QC Date

July 28, 2026

Last Update Submit

July 28, 2026

Conditions

Keywords

Intraoral ScannerDigital impressionPassive fitAuxiliary Geometric DeviceFixed Detachable ProsthesisImplant Scan BodyFull-arch implanthorizontal scan body

Outcome Measures

Primary Outcomes (2)

  • Implant linear and angular deviation

    The linear and angular deviations of implants will be compared and analyzed across different scanning techniques against each other

    Immediately after completion of digital scanning day 0

  • Three-Dimensional part comparison

    Three-dimensional surface deviation will be evaluated by uploading all STL files to dedicated comparison software. Digital superimposition will be performed to calculate the median surface deviation and root mean square (RMS) values between the datasets, providing a quantitative assessment of surface discrepancies among the three scanning techniques.

    Immediately after completion of digital scanning day 0

Secondary Outcomes (1)

  • fit of verification jig

    Within 1 hour of fabrication and intraoral placement of the verification jig

Study Arms (3)

Splinted Scan Bodies with composite

EXPERIMENTAL

Participants will undergo full-arch digital implant scanning using implant scan bodies splinted with composite resin. The splinting procedure is intended to improve the stability of scan bodies and reduce positional discrepancies during digital impression acquisition.

Device: Splinted Scan Body with composite

horizontal non-calibrated scan bodies

EXPERIMENTAL

Participants will undergo full-arch digital implant scanning using horizontal non-calibrated scan bodies (IO Connect). This technique utilizes a horizontal scan body design to facilitate implant position recognition, digital alignment, and complete-arch digital impression acquisition.

Device: IO Connect Scanning Technique

Auxiliary Geometric Device Scanning

EXPERIMENTAL

Participants will undergo full-arch digital implant scanning using 3D-printed auxiliary geometric devices attached to implant scan bodies. The auxiliary devices provide additional geometric reference landmarks intended to improve scanning accuracy and reduce stitching errors during complete-arch digital impressions.

Device: Auxiliary Geometric Device Scanning Technique

Interventions

A full-arch digital implant impression will be obtained using implant scan bodies splinted with composite resin prior to scanning. The splinting procedure will provide enhanced scan body stability and will be used to minimize positional discrepancies during digital impression acquisition.

Splinted Scan Bodies with composite

A full-arch digital implant impression will be obtained using horizontal non-calibrated scan bodies (IO Connect). The horizontal scan body design will facilitate implant position recognition, digital alignment, and accurate transfer of implant coordinates throughout the digital impression procedure.

horizontal non-calibrated scan bodies

A full-arch digital implant impression will be obtained using 3D-printed auxiliary geometric devices attached to implant scan bodies. These auxiliary devices will provide additional geometric reference landmarks to improve stitching accuracy, reduce cumulative scanning errors, and enhance complete-arch digital impression accuracy.

Auxiliary Geometric Device Scanning

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Completely edentulous patients with age between 40-60 years.
  • Adequate bone height to fulfill the criteria for implant placement.
  • Patients should have a class I Angle's classification.

You may not qualify if:

  • Insufficient vertical inter-arch space to accommodate the restorative components.
  • \. Presence of psychiatric or neurological conditions. 3. Any systemic diseases that may affect implant bone osteointegration.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Tanta University

Tanta, Gharbia Governorate, 31527, Egypt

RECRUITING

Study Officials

  • Mostafa Hamed Mostafa Abd El-Hameed Abd El-Hameed, BDS, MSc

    Faculty of Dentistry, Tanta University, Egypt

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mostafa Hamed Mostafa Abd El-Hameed Abd El-Hameed, BDS, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
CROSSOVER
Model Details: Each participant will undergo all three intraoral scanning techniques in a randomized sequence. The three scanning techniques include splinted scan bodies, horizontal non-calibrated scan bodies (IO Connect), and auxiliary geometric devices. The crossover design allows within-subject comparison of scanning accuracy and passive fit while minimizing inter-participant variability.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

July 28, 2026

First Posted

July 31, 2026

Study Start (Estimated)

August 8, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

July 31, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations