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

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.

Study Overview

• Status: Completed
• Conditions: Dental Malocclusion
• Intervention / Treatment: Device: LightForce Orthodontic System

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Maple, Ontario, Canada, L6A 0A9
      • Walt Orthodontics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with Malocclusion	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Length of Bonding Appointment	1 day
Number of Debonded Brackets	approximately 2 years
Length of Treatment	approximately 2 years
Length of Debond Appointment	1 day
Length of Time to Achieve Leveling and Aligning	2 years
Number of Unscheduled Appointments	2 years
Number of Repositioned Brackets	2 years

Collaborators and Investigators

• Sponsor: LightForce Orthodontics
• Investigators: Study Director: Kelsey Fafara, BS, LightForce Orthodontics

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2020
• Primary Completion (Actual): July 30, 2023
• Study Completion (Actual): July 30, 2023

Study Registration Dates

• First Submitted: February 10, 2020
• First Submitted That Met QC Criteria: February 10, 2020
• First Posted (Actual): February 12, 2020

Study Record Updates

• Last Update Posted (Actual): November 27, 2024
• Last Update Submitted That Met QC Criteria: November 4, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion
• Other Study ID Numbers: Pro00040384

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes