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
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Dental Malocclusion
• Malocclusion

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