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

Not Applicable

Completed

• Conditions: Dental Malocclusion
• Interventions: Device: LightForce Orthodontic System

• Registration Number: NCT04266769
• Lead Sponsor: LightForce Orthodontics

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-10
• Study First Submitted: 2020-02-10
• Study First Submitted QC: 2020-02-10
• Study First Posted: 2020-02-12
• Primary Completion: 2023-07-30
• Study Completion: 2023-07-30
• Results First Submitted: 2024-01-11
• Status Verified: 2024-11
• Results First Submitted QC: 2024-11-04
• Last Update Submitted: 2024-11-04
• Results First Posted: 2024-11-27
• Last Update Posted: 2024-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with Malocclusion	LightForce Orthodontic System	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Walt Orthodontics; 🇨🇦 Maple, Ontario, Canada