Feasibility study of the uLab treatment planning software

ISRCTN ISRCTN11232617
DOI https://doi.org/10.1186/ISRCTN11232617
Secondary identifying numbers ULAB102
Submission date
13/06/2019
Registration date
18/06/2019
Last edited
03/02/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Contact information

Mr Scott Rehage
Public

3 Lagoon Drive
Suite 180
Redwood City
94065
United States of America

ORCiD logoORCID ID 0000-0003-1900-4098
Phone (925) 683-2590
Email srehage@yahoo.com

Study information

Study designNon randomised interventional
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)GP practice
Study typeTreatment
Participant information sheet No participant information sheet available
Scientific titleEvaluation of appliance fit and treatment outcome with use of the uLab system
Study objectivesIt 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(s)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
Health condition(s) or problem(s) studiedOrthodontics - treating crowding and spacing malocclusions
InterventionThroughout 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 typeDevice
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)
Primary outcome measurePercentage of dental appliance with acceptable fit (pass/fail), measured during patient consultations (approx. every 6 months).
Secondary outcome measures1. 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 study start date01/06/2019
Completion date01/06/2021

Eligibility

Participant type(s)All
Age groupAll
SexBoth
Target number of participants500
Key inclusion criteria1. 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)
Key exclusion criteria1. 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
Date of first enrolment01/07/2019
Date of final enrolment01/07/2020

Locations

Countries of recruitment

  • Canada

Study participating centres

Dr. Paul Pocock - Smiles by Pocock
224 West Esplanade
Suite 600
North Vancouver
BC V7M 1A4
Canada
Dr. Joseph Stanley - All Smiles Orthodontics
560 Main St
#35Place
Saint John
E2K 1J5
Canada
Dionne Orthodontics
12329 Tecumseh Rd
Tecumseh, Ontario
N8N1M5
Canada
Family Braces North Clinic - Dr. Fouad Ebrahim
Beacon Hill Shopping Center
11820 Sarcee Trail NW
Calgary
T3R 0A1
Canada

Sponsor information

uLab Systems Inc.
Industry

3 Lagoon Drive
Suite 180
Redwood City, California
94065
United States of America

Phone (866) 900-8522
Email info@ulabsystems.com
Website https://www.ulabsystems.com/

Funders

Funder type

Industry

uLab Systems Inc.

No information available

Results and Publications

Intention to publish date01/08/2022
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal
IPD sharing planThe current data sharing plans for this study are unknown and will be available at a later date

Editorial Notes

03/02/2020: The trial participating centre "Family Braces North Clinic" was added.
17/10/2019: The trial participating centre "Dionne Orthodontics" was added.
18/06/2019: Trial’s existence confirmed by Veritas IRB.