NCT03103802

Brief Summary

This study is to compare the diagnostic accuracy of digital models obtained via 10 digitization techniques to the reference standard of orthodontic plaster model through dental measurements

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

April 1, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 6, 2017

Completed
24 days until next milestone

Study Start

First participant enrolled

April 30, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2018

Completed
Last Updated

April 11, 2017

Status Verified

April 1, 2017

Enrollment Period

6 months

First QC Date

April 1, 2017

Last Update Submit

April 9, 2017

Conditions

Orthodontics

Outcome Measures

Primary Outcomes (1)

  • diagnostic accuracy

    evaluation of the accuracy of digital models obtained using scanners

    6 months

Study Arms (5)

Intra-oral scanning

EXPERIMENTAL
Device: intra-oral digital scanner and extra-oral digital scanner

extra-oral scanning of the plaster model obtained via alginate

EXPERIMENTAL
Device: intra-oral digital scanner and extra-oral digital scanner

extra-oral scanning of plaster model obtained via rubber base

EXPERIMENTAL
Device: intra-oral digital scanner and extra-oral digital scanner

extra-oral scanning of the rubber base impression

EXPERIMENTAL
Device: intra-oral digital scanner and extra-oral digital scanner

extra-oral scanning of the alginate impression

EXPERIMENTAL
Device: intra-oral digital scanner and extra-oral digital scanner

Interventions

intra-oral digital scanner and extra-oral digital scannerDEVICE

intra-oral and extra-oral digital scanners used to obtain digital models

Intra-oral scanningextra-oral scanning of plaster model obtained via rubber baseextra-oral scanning of the alginate impressionextra-oral scanning of the plaster model obtained via alginateextra-oral scanning of the rubber base impression

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • adult patients seeking orthodontic treatment permanent dentition

You may not qualify if:

  • deciduous or mixed dentition cleft lip and palate patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry- Cairo University

Cairo Governorate, Cairo Governorate, 12613, Egypt

RECRUITING

Study Officials

  • Khaled Hazem, PHD

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

Mohamed A Labib, DDS

CONTACT

00201222144339mohamedlabib90@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Intern Student

Study Record Dates

First Submitted

April 1, 2017

First Posted

April 6, 2017

Study Start

April 30, 2017

Primary Completion

October 30, 2017

Study Completion

February 27, 2018

Last Updated

April 11, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will share

Locations

EG(1)