Back to resultsPrecision Orthodontics: A Comparison of Custom vs Traditional Bracket Treatment Efficiency
Primary Purpose
Dental Malocclusion
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
LightForce Orthodontic System
Sponsored by
About this trial
This is an interventional treatment trial for Dental Malocclusion
Eligibility Criteria
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
Sites / Locations
- Walt Orthodontics
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with Malocclusion
Arm Description
Outcomes
Primary Outcome Measures
Length of treatment
Length of bonding appointment
Length of debonding appointment
Length of time to achieve leveling and aligning
number of unscheduled appointment
number of debonded brackets
number of repositioned brackets
Secondary Outcome Measures
Full Information
NCT ID
NCT04266769
First Posted
February 10, 2020
Last Updated
August 31, 2021
Sponsor
LightForce Orthodontics
1. Study Identification
Unique Protocol Identification Number
NCT04266769
Brief Title
Precision Orthodontics: A Comparison of Custom vs Traditional Bracket Treatment Efficiency
Official Title
Precision Orthodontics: A Comparison of Custom vs Traditional Bracket Treatment Efficiency
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
February 10, 2020 (Actual)
Primary Completion Date
August 29, 2021 (Actual)
Study Completion Date
August 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LightForce Orthodontics
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Malocclusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with Malocclusion
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
LightForce Orthodontic System
Intervention Description
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 Outcome Measure Information:
Title
Length of treatment
Time Frame
approximately 2 years
Title
Length of bonding appointment
Time Frame
1 day
Title
Length of debonding appointment
Time Frame
approximately 2 years
Title
Length of time to achieve leveling and aligning
Time Frame
approximately 1 years
Title
number of unscheduled appointment
Time Frame
approximately 2 years
Title
number of debonded brackets
Time Frame
approximately 2 years
Title
number of repositioned brackets
Time Frame
approximately 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelsey Fafara, BS
Organizational Affiliation
LightForce Orthodontics
Official's Role
Study Director
Facility Information:
Facility Name
Walt Orthodontics
City
Maple
State/Province
Ontario
ZIP/Postal Code
L6A 0A9
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Precision Orthodontics: A Comparison of Custom vs Traditional Bracket Treatment Efficiency
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