Precision Orthodontics: A Comparison of Custom vs Traditional Bracket Treatment Efficiency
1 other identifier
interventional
14
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2020
CompletedStudy Start
First participant enrolled
February 10, 2020
CompletedFirst Posted
Study publicly available on registry
February 12, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2023
CompletedResults Posted
Study results publicly available
November 27, 2024
CompletedNovember 27, 2024
November 1, 2024
3.5 years
February 10, 2020
January 11, 2024
November 4, 2024
Conditions
Outcome Measures
Primary Outcomes (7)
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
Study Arms (1)
Patients with Malocclusion
EXPERIMENTALInterventions
The LightForce Orthodontic System is a a digital treatment planning platform and patient-specific 3D printed polycrystalline alumina brackets for the treatment of malocclusion
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Walt Orthodontics
Maple, Ontario, L6A 0A9, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Kelsey Fafara
- Organization
- LightForce Orthodontics
Study Officials
- STUDY DIRECTOR
Kelsey Fafara, BS
LightForce Orthodontics
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2020
First Posted
February 12, 2020
Study Start
February 10, 2020
Primary Completion
July 30, 2023
Study Completion
July 30, 2023
Last Updated
November 27, 2024
Results First Posted
November 27, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share