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Feasibility study of the uLab treatment planning software

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN11232617
Enrollment
500
Registered
2019-06-18
Start date
2019-07-01
Completion date
Unknown
Last updated
2020-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orthodontics - treating crowding and spacing malocclusions Oral Health Dentofacial anomalies

Interventions

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

Sponsors

uLab Systems Inc.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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)

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
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).

Countries

Canada

Contacts

Public ContactScott Rehage
srehage@yahoo.com(925) 683-2590

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026