Trial Outcomes & Findings for Precision Orthodontics: A Comparison of Custom vs Traditional Bracket Treatment Efficiency (NCT NCT04266769)

NCT ID: NCT04266769

Last Updated: 2024-11-27

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 14 participants
• Primary outcome timeframe: 1 day
• Results posted on: 2024-11-27

Participant Flow

Participant milestones

Measure	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
Overall Study STARTED	14
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Patients With Malocclusion n=14 Participants 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
Age, Categorical <=18 years	10 Participants n=14 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=14 Participants
Age, Categorical >=65 years	0 Participants n=14 Participants
Sex: Female, Male Female	8 Participants n=14 Participants
Sex: Female, Male Male	6 Participants n=14 Participants
Region of Enrollment Canada	14 participants n=14 Participants

PRIMARY outcome

Timeframe: 1 day

Outcome measures

Measure	Patients With Malocclusion n=14 Participants 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
Length of Bonding Appointment	33 minutes Standard Deviation 11

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Patients With Malocclusion n=13 Participants 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
Number of Debonded Brackets	3 number of brackets Standard Deviation 2

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Patients With Malocclusion n=13 Participants 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
Length of Treatment	27 months Standard Deviation 9

PRIMARY outcome

Timeframe: 1 day

Population: One patient did not complete treatment as they moved out of town and no longer went to the study's orthodontists.

Outcome measures

Measure	Patients With Malocclusion n=13 Participants 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
Length of Debond Appointment	60 minutes Standard Deviation 0

PRIMARY outcome

Timeframe: 2 years

Population: One patient did not complete treatment as they moved out of town and no longer went to the study's orthodontists.

Outcome measures

Measure	Patients With Malocclusion n=13 Participants 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
Length of Time to Achieve Leveling and Aligning	16 months Standard Deviation 7

PRIMARY outcome

Timeframe: 2 years

Population: One patient did not complete treatment as they moved out of town and no longer went to the study's orthodontists.

Outcome measures

Measure	Patients With Malocclusion n=13 Participants 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
Number of Unscheduled Appointments	3 number of appointments Standard Deviation 2

PRIMARY outcome

Timeframe: 2 years

Population: One patient did not complete treatment as they moved out of town and no longer went to the study's orthodontists.

Outcome measures

Measure	Patients With Malocclusion n=13 Participants 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
Number of Repositioned Brackets	1 number of brackets Standard Deviation 2

Adverse Events

Patients With Malocclusion

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kelsey Fafara

LightForce Orthodontics

Phone: 7329775646

Email: kelsey@lightforceortho.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place