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NCT04266769 Clinical Trial

Precision Orthodontics: A Comparison of Custom vs Traditional Bracket Treatment Efficiency

Dental Malocclusion Clinical Trial

Official title:
Precision Orthodontics: A Comparison of Custom vs Traditional Bracket Treatment Efficiency

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04266769
Other study ID # Pro00040384
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 10, 2020
Est. completion date August 30, 2021

Study information
Verified date August 2021
Source LightForce Orthodontics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This investigational testing aims to target multiple investigations sites to examine treatment efficiency metrics using a completely digital and patient-specific bracket treatment system for the correction of malocclusions.

Recruitment information / eligibility
Status Completed
Enrollment 14
Est. completion date August 30, 2021
Est. primary completion date August 29, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 10 Years to 65 Years
Eligibility Inclusion Criteria: - All subjects must be healthy and between the ages of 10 and 65. - Eruption of all permanent teeth excluding second and third molars - Sufficient labial tooth surface for bonding - No more than one tooth missing from a single arch quadrant - No existing molar tubes or bands Exclusion Criteria: - Presence of systemic diseases, cleft lip and palate, craniofacial anomalies, syndromes affecting bone or teeth, impacted teeth (excluding 3rd molars), and tumors of the parathyroid gland - Presence of bridges or implants - Cases requiring orthognathic surgery - Significant periodontal disease - Intake of drugs affecting tooth movement or bone formation (chronic use of Non-Steroidal Anti-Inflammatory Drugs, bisphosphonates, levothyroxine, or teriparatide drug class) - Pregnancy

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• LightForce Orthodontic System
The LightForce Orthodontic System is a a digital treatment planning platform and patient-specific 3D printed polycrystalline alumina brackets for the treatment of malocclusion

Locations
Country Name City State
Canada Walt Orthodontics Maple Ontario

Sponsors (1)
Lead Sponsor Collaborator
LightForce Orthodontics

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Length of treatment approximately 2 years
Primary Length of bonding appointment 1 day
Primary Length of debonding appointment approximately 2 years
Primary Length of time to achieve leveling and aligning approximately 1 years
Primary number of unscheduled appointment approximately 2 years
Primary number of debonded brackets approximately 2 years
Primary number of repositioned brackets approximately 2 years
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