Dentition/Teeth MeasurementNCT01934517

Validity of Digital Models Obtained With iTero® and Lava Digital® in Comparison With Plaster Models.

An observational study of Dentition/Teeth Measurement, run by Université de Montréal at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to evaluate the validity, reliability and reproducibility of digital models obtained from iTero® and Lava Digital® in comparison with traditional plaster models. Read more about this study

Who is it for?: Ages 12 to 30 years
Conditions the study is for: Dentition/Teeth Measurement
How many people: 25 participants
Where: 1 siteCanada
Study dates: Aug 2013to Jun 2015
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 30 years
All sexes
No healthy volunteers
Child, Adult

Study population: Patients requiring an orthodontic treatment from the Orthodontics clinic of the University of Montreal

Who may be able to join

Aged between 12 and 30 years old (male or female)
complete permanent dentition from first molar to the other first molar
no interproximal modifications (e.g. decay, large restorations, abnormal tooth morphology) which could affect the mesio-distal width of the teeth

Who cannot join

Dentition with severe crowding (that could therefore affect the mesio-distal width of the teeth)

Trial locations and contacts

1 site in 1 country.

Canada1 site

University of Montreal, Faculty of Orthodontics
Montreal, Quebec, H3V1H9

Other trials in Canada

About this study

Official title: Validity, Reliability and Reproducibility of Digital Models Obtained With iTero® (AlignTech) and Lava Digital® (3M) in Comparison With Plaster Models.

The purpose of this study is to evaluate the validity, reliability and reproducibility of digital models obtained from iTero® and Lava Digital® in comparison with traditional plaster models.

Read the detailed description

The primary objective of this study is to evaluate the validity, reliability and reproducibility of the dental measurements obtained on the digital models with iTero® in comparison with those obtained on the plaster models (gold standard) and on the digital models with Lava Digital®.

The secondary objective is to compare two different impression materials (i.e. alginate and polyvinylsiloxane (PVS)) and determine whether the impression material used affects the accuracy of the measurements.

Statistical analysis:

Intraclass correlation coefficient (ICC) will be used to evaluate the intra- and inter-operator reliability of the measurements for each method, i.e. the plaster models and the digital models.
A paired t-test will be used to determine the validity of the digital measurements with iTero®, and to compare the impression materials (alginate and PVS).
A Bland-Altman plot will also be used to compare the two digital methods (Lava Digital® et iTero®) with the plaster models.
Dahlberg coefficient will be used to evaluate the technical error associated with the measurements that will be made.

Conditions: Dentition/Teeth Measurement

What is being measured

The primary outcome is the main question the study is designed to answer.

Overjet
Overjet: measured as the greatest horizontal distance from the labial surface of the lower central incisor to the most inferior point at the mesiodistal center of the upper central incisor
Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2013Jun 2015

First posted4 Sep 2013 (estimated)
Study startAug 2013
Primary completionMay 2014
Study completionJun 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Dentition/Teeth MeasurementStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01934517
Sponsor's protocol ID: VCP2013udem
Status last verified: Jan 2016
First submitted: 29 Aug 2013
Last updated: 15 Feb 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Dentition/Teeth Measurement trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Validity, Reliability and Reproducibility of Digital Models Obtained With iTero® (AlignTech) and Lava Digital® (3M) in Comparison With Plaster Models.
ClinicalTrials.gov ID: NCT01934517
Acronym / sponsor ID: VCP2013udem
Conditions: Dentition/Teeth Measurement
Study type: Observational
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: Université de MontréalUniversity, hospital or other
Study start: Aug 2013
Primary completion: May 2014 (actual)
Study completion: Jun 2015 (actual)
First posted: 4 Sep 2013 (estimated)
Results: Posted 15 Feb 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate the validity, reliability and reproducibility of digital models obtained from iTero® and Lava Digital® in comparison with traditional plaster models.

Detailed description

Statistical analysis:

Intraclass correlation coefficient (ICC) will be used to evaluate the intra- and inter-operator reliability of the measurements for each method, i.e. the plaster models and the digital models.
A paired t-test will be used to determine the validity of the digital measurements with iTero®, and to compare the impression materials (alginate and PVS).
A Bland-Altman plot will also be used to compare the two digital methods (Lava Digital® et iTero®) with the plaster models.
Dahlberg coefficient will be used to evaluate the technical error associated with the measurements that will be made.

Study design

Observational model: Case only
Time perspective: Prospective

Who may qualify

Ages: 12 to 30 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult
Study population: Patients requiring an orthodontic treatment from the Orthodontics clinic of the University of Montreal

Key inclusion criteria (3 listed)

Aged between 12 and 30 years old (male or female)
complete permanent dentition from first molar to the other first molar
no interproximal modifications (e.g. decay, large restorations, abnormal tooth morphology) which could affect the mesio-distal width of the teeth

Key exclusion criteria (1 listed)

Dentition with severe crowding (that could therefore affect the mesio-distal width of the teeth)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Overjet
Time frame: one year
Overjet: measured as the greatest horizontal distance from the labial surface of the lower central incisor to the most inferior point at the mesiodistal center of the upper central incisor

Results and safety

Results posted to the registry on 15 Feb 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
iTero, Lava Digital and Plaster Models: All Study Participants	25	25

Primary outcome: Overjet

Time frame: one year. Mean (95% Confidence Interval). Unit: mm

Measure	iTero Models n = 25	Plaster Models n = 25	Lava Digital Models n = 25
Value	0.25 (-0.65 to 1.16)	0.27 (-0.78 to 1.25)	0.28 (-0.58 to 1.20)

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
iTero Models	0 of 25 (0%)	0 of 25 (0%)	Not reported
Plaster Models	0 of 25 (0%)	0 of 25 (0%)	Not reported
Lava Digital Models	0 of 25 (0%)	0 of 25 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Dentition/Teeth Measurement

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Identification of Novel Biomarkers in Early Charcot-Marie-Tooth 1A Disease
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Dental Implant, Implant Therapy
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A Prospective Natural History and Outcome Measure Discovery Study of Charcot-Marie-Tooth Disease, Type 4J
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Vincent-Claude Peloquin, resident principal investigator

University of Montreal, department of Orthodontics

Normand Bach, D.M.D., M.Sc., F.R.C.D.(c) study director

Université de Montréal

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Dentition/Teeth Measurement, run by Université de Montréal at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overjet (time frame: one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01934517.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2016.