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OpenTrials
Completed

NCT Number: NCT04266769

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.

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Key information

Conditions

Dental Malocclusion Malocclusion Stomatognathic Diseases Tooth Diseases

Age range

10 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Walt Orthodontics

Maple, Ontario, L6A 0A9, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LightForce Orthodontic System

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

Primary outcomes

  1. Length of Bonding Appointment

    Time frame: 1 day

  2. Number of Debonded Brackets

    Time frame: approximately 2 years

  3. Length of Treatment

    Time frame: approximately 2 years

  4. Length of Debond Appointment

    Time frame: 1 day

  5. Length of Time to Achieve Leveling and Aligning

    Time frame: 2 years

  6. Number of Unscheduled Appointments

    Time frame: 2 years

  7. Number of Repositioned Brackets

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

LightForce Orthodontics

Industry

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Feb 12, 2020
Registry last updated
Nov 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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