Condition category
Oral Health
Date applied
13/06/2019
Date assigned
18/06/2019
Last edited
17/10/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Traditional orthodontic treatment planning practice has remained substantially unchanged for the past 20 years. Ulab Systems Inc. (“Ulab”) has developed a new digital treatment planning software that is significantly faster than the conventional treatment planning software on the market.
The purpose of this study is to gather data regarding the fit of the dental appliance(s) fabricated from the treatment plan generated from Ulab Systems, Inc. for treating crowding and spacing malocclusions (or imperfect positioning of teeth) in approximately 500 patients within the age range of 7-80. The study is evaluating the Ulab Systems, Inc. software and not the actual appliances that participants will be wearing. Only standard laboratory practices and approved materials will be used to create your appliances.

Who can participate?
Patients between 7 and 80 years old, with mild to moderate spacing or crowding of their teeth.

What does the study involve?
Gathering data about the fit of dental appliances created from images of a patients teeth using treatment planning software from uLab Systems, Inc. This data will be gathered during ususal treatment sessions.

What are the possible benefits and risks of participating?
The study may or may not help patients, however it may help patients in the future. There is no anticipation of any problems and the only discomfort would be minor tooth soreness that is normal during tooth movement.

Where is the study run from?
The study will be run by selected investigators at their local dental practices.

When is the study starting and how long is it expected to run for?
August 2019 to August 2021

Who is funding the study?
uLab Systems Inc., CA, USA

Who is the main contact?
Mr Scott Rehage

Trial website

Contact information

Type

Public

Primary contact

Mr Scott Rehage

ORCID ID

http://orcid.org/0000-0003-1900-4098

Contact details

3 Lagoon Drive
Suite 180
Redwood City
94065
United States of America
(925) 683-2590
srehage@yahoo.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

ULAB102

Study information

Scientific title

Evaluation of appliance fit and treatment outcome with use of the uLab system

Acronym

Study hypothesis

It is expected that the appliances fabricated from the Ulab software will fit much better than conventional clear orthodontic appliances, mainly because Ulab is the only system that retains the actual digital gingival information. In turn, it is expected that appliances made from the digital data will fit the dentition of the patient much better.

Ethics approval

Approved 14/06/2019, Veritas IRB (8555 Transcanada Hwy, Suite 201, Montreal, QC H4S 1Z6, Canada; +1.866.384.4221; infoirb@veritasirb.com), ref: 16358-14:02:2

Study design

Non randomised interventional

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Orthodontics - treating crowding and spacing malocclusions

Intervention

Throughout the study successive dental appliances will be provided to gradually reposition patients teeth and the fit of the devices will be assessed by the investigator. Each office visit will take approximately one hour. This study will last as long as it takes to straighten patients teeth, approximately 6 months to 1 year or longer, and will include visits to the study doctor’s office approximately every 4 to 8 weeks. Dental appliance(s) fabricated from the STL file generated from the Ulab treatment planning software

The Ulab software will use a computer as a tool to assist in programming a series of sequential tooth movements to ensure appropriate, consistent forces on the patient’s teeth per investigators desired prescription. The investigator will program a treatment plan using the Ulab software, and determine how many steps will be required to achieve the desired treatment outcome. Once the treatment plan is programmed by the investigator, they can fabricate the appliances in their own office or via a third party orthodontic laboratory, using the standard dental laboratory practices and approved materials used by the dental industry.

Intervention type

Device

Phase

Not Applicable

Drug names

Primary outcome measure

Percentage of dental appliance with acceptable fit (pass/fail), measured during patient consultations (approx. every 6 months).

Secondary outcome measures

1. Oral hygiene based on gender and age (poor/fair/good), measured during patient consultations (approx. every 6 months).
2. Patient compliance (poor/fair/good), measured during patient consultations (approx. every 6 months).

Overall trial start date

01/06/2019

Overall trial end date

01/06/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Between 7 and 80 years of age
2. Fully erupted 7 to 7 upper and lower
3. Permanent dentition
4. Class I Mild to moderate spacing case (1-6 mm)
5. Class I Mild to moderate crowding cases (1-6 mm)

Participant type

All

Age group

All

Gender

Both

Target number of participants

500

Participant exclusion criteria

1. The legally authorized representative/ guardian is unable or unwilling to consent.
2. Patients with periodontal disease that would preclude orthodontic treatment.
3. Extraction other than a single lower incisor
4. Cases requiring autorotation of the mandible for vertical/A-P correction
5. Severe deep bites to be opened to ideal
6. Cases with erupting permanent teeth or mixed dentition
7. Pre-orthognathic surgery cases
8. Short clinical crowns
9. Up righting of severely tipped teeth (tipped greater than 45 degrees)
10. A-P corrections greater than 2mm
11. Cases with multiple missing teeth
12. Untreated periodontal disease
13. Existing decay/poor restorations
14. Resolution of moderate-severe CR-CO discrepancy
15. Severe open bites to be closed to ideal
16. Significant TMJ symptoms/pathology
17. Unidirectional movement of an entire dental arch
18. Closure of posterior open bite
19. Correction of impacted dentition/forced eruption

Recruitment start date

01/07/2019

Recruitment end date

01/07/2020

Locations

Countries of recruitment

Canada

Trial participating centre

Dr. Paul Pocock - Smiles by Pocock
224 West Esplanade Suite 600
North Vancouver
BC V7M 1A4
Canada

Trial participating centre

Dr. Joseph Stanley - All Smiles Orthodontics
560 Main St #35Place
Saint John
E2K 1J5
Canada

Trial participating centre

Dionne Orthodontics
12329 Tecumseh Rd
Tecumseh, Ontario
N8N1M5
Canada

Sponsor information

Organisation

uLab Systems Inc.

Sponsor details

3 Lagoon Drive
Suite 180
Redwood City
California
94065
United States of America
(866) 900-8522
info@ulabsystems.com

Sponsor type

Industry

Website

https://www.ulabsystems.com/

Funders

Funder type

Industry

Funder name

uLab Systems Inc.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal

IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date

Intention to publish date

01/08/2022

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

17/10/2019: The trial participating centre "Dionne Orthodontics" was added. 18/06/2019: Trial’s existence confirmed by Veritas IRB.