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

NCT ID: NCT04266769

Last Updated: 2024-11-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-10

Study Completion Date

2023-07-30

Brief Summary

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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

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Conditions

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Dental Malocclusion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patients with Malocclusion

Group Type EXPERIMENTAL

LightForce Orthodontic System

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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LightForce Orthodontics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kelsey Fafara, BS

Role: STUDY_DIRECTOR

LightForce Orthodontics

Locations

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Walt Orthodontics

Maple, Ontario, Canada

Site Status

Countries

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Canada

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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Pro00040384

Identifier Type: -

Identifier Source: org_study_id

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