Dental Malocclusion
Conditions
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.
Interventions
DEVICELightForce 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
Sponsors
LightForce Orthodontics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients With Malocclusion 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 | 14 |
| Total | 14 |
Baseline characteristics
| Characteristic | Patients With Malocclusion | — |
|---|---|---|
| Age, Categorical <=18 years | 10 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 4 Participants | — |
| length of debonding appointment | — | — Minutes |
| length of time to achieve level and align | — | — months |
| Length of treatment | — | — months |
| Number of repositioned brackets | — | — number of brackets |
| number of unscheduled appointments | — | — number of brackets |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Canada | 14 participants | — |
| Sex: Female, Male Female | 8 Participants | — |
| Sex: Female, Male Male | 6 Participants | — |
| Time to Bond | — | — Minutes |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 14 |
| other Total, other adverse events | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 |
Outcome results
Primary
Length of Bonding Appointment
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients With Malocclusion | Length of Bonding Appointment | 33 minutes | Standard Deviation 11 |
Primary
Length of Debond Appointment
Time frame: 1 day
Population: One patient did not complete treatment as they moved out of town and no longer went to the study's orthodontists.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients With Malocclusion | Length of Debond Appointment | 60 minutes | Standard Deviation 0 |
Primary
Length of Time to Achieve Leveling and Aligning
Time frame: 2 years
Population: One patient did not complete treatment as they moved out of town and no longer went to the study's orthodontists.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients With Malocclusion | Length of Time to Achieve Leveling and Aligning | 16 months | Standard Deviation 7 |
Primary
Length of Treatment
Time frame: approximately 2 years
Population: One patient did not complete treatment as they moved out of town and no longer went to the study's orthodontists.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients With Malocclusion | Length of Treatment | 27 months | Standard Deviation 9 |
Primary
Number of Debonded Brackets
Time frame: approximately 2 years
Population: One patient did not complete treatment as they moved out of town and no longer went to the study's orthodontists.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients With Malocclusion | Number of Debonded Brackets | 3 number of brackets | Standard Deviation 2 |
Primary
Number of Repositioned Brackets
Time frame: 2 years
Population: One patient did not complete treatment as they moved out of town and no longer went to the study's orthodontists.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients With Malocclusion | Number of Repositioned Brackets | 1 number of brackets | Standard Deviation 2 |
Primary
Number of Unscheduled Appointments
Time frame: 2 years
Population: One patient did not complete treatment as they moved out of town and no longer went to the study's orthodontists.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients With Malocclusion | Number of Unscheduled Appointments | 3 number of appointments | Standard Deviation 2 |