Dental MalocclusionNCT04266769

Precision Orthodontics: A Comparison of Custom vs Traditional Bracket Treatment Efficiency

A study testing LightForce Orthodontic System in people with Dental Malocclusion, run by LightForce Orthodontics at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 10 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Dental Malocclusion
What is being tested?: LightForce Orthodontic System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 1 siteCanada
Study dates: 10 Feb 2020to 30 Jul 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 10 to 65 years
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site

Walt Orthodontics
Maple, Ontario, L6A 0A9

Other trials in Canada

About this study

Conditions: Dental Malocclusion
Being tested: LightForce Orthodontic System
Medical subject headings: Malocclusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LightForce Orthodontic SystemDevice
The LightForce Orthodontic System is a a digital treatment planning platform and patient-specific 3D printed polycrystalline alumina brackets for the treatment of malocclusion

Study groups in NCT04266769
Study group	Role	What they receive
Patients with Malocclusion	Experimental	Not described Receives: Device: LightForce Orthodontic System

What is being measured

The primary outcome is the main question the study is designed to answer.

Length of Bonding Appointment
Measured: 1 day
Number of Debonded Brackets
Measured: approximately 2 years
Length of Treatment
Measured: approximately 2 years
Length of Debond Appointment
Measured: 1 day
Length of Time to Achieve Leveling and Aligning
Measured: 2 years
Number of Unscheduled Appointments
Measured: 2 years
Number of Repositioned Brackets
Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Feb 202030 Jul 2023

First posted12 Feb 2020
Study start10 Feb 2020
Primary completion30 Jul 2023
Study completion30 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Dental MalocclusionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04266769
Sponsor's protocol ID: Pro00040384
Status last verified: Nov 2024
First submitted: 10 Feb 2020
Last updated: 27 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitation
Discision as Acceleration Method in Canine Retraction in Orthodontics With Aligner and Fixed Appliances in Young Adults a Split Mouth Study
Bimaxillary Protrusion, Class II Div 1 Malocclusion
Recruiting
Assessment of the Locally Administrated Vitamin D3 and Corticision Efficacy on Orthodontic Canine Retraction
Malocclusions, Canine Retraction
Not yet recruiting
Timing, Trajectories and Prediction in Severe Dental Crowding: The Create SPACE (cSPACE)
Crowding of Teeth, Malocclusion; Displaced Teeth
Recruiting
FM Technique in Orthodontic Clear Aligner Therapy: A Single-Arm Clinical Study
Malocclusion
Not yet recruiting
Treatment of Mandibular Overjet in Children With Maxillary Retrognathism
Maxillary Retrognathism, Children

All Dental Malocclusion trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Precision Orthodontics: A Comparison of Custom vs Traditional Bracket Treatment Efficiency
ClinicalTrials.gov ID: NCT04266769
Acronym / sponsor ID: Pro00040384
Conditions: Dental Malocclusion
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: LightForce OrthodonticsIndustry (pharma, biotech, devices)
Study start: 10 Feb 2020 (actual)
Primary completion: 30 Jul 2023 (actual)
Study completion: 30 Jul 2023 (actual)
First posted: 12 Feb 2020 (actual)
Results: Posted 27 Nov 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Patients with Malocclusion	Experimental	Device: LightForce Orthodontic System

Who may qualify

Ages: 10 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (6 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LightForce Orthodontic SystemThe LightForce Orthodontic System is a a digital treatment planning platform and patient-specific 3D printed polycrystalline alumina brackets for the treatment of malocclusion	Device	Patients with Malocclusion

Primary outcome

Length of Bonding Appointment
Time frame: 1 day
Number of Debonded Brackets
Time frame: approximately 2 years
Length of Treatment
Time frame: approximately 2 years
Length of Debond Appointment
Time frame: 1 day
Length of Time to Achieve Leveling and Aligning
Time frame: 2 years
Number of Unscheduled Appointments
Time frame: 2 years
Number of Repositioned Brackets
Time frame: 2 years

Results and safety

Results posted to the registry on 27 Nov 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patients With Malocclusion	14	14

Primary outcome: Length of Bonding Appointment

Time frame: 1 day. Mean (Standard Deviation). Unit: minutes

Measure	Patients With Malocclusion n = 14
Value	33 (11)

Primary outcome: Number of Debonded Brackets

Time frame: approximately 2 years. Mean (Standard Deviation). Unit: number of brackets

Measure	Patients With Malocclusion n = 13
Value	3 (2)

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

Primary outcome: Length of Treatment

Time frame: approximately 2 years. Mean (Standard Deviation). Unit: months

Measure	Patients With Malocclusion n = 13
Value	27 (9)

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

Primary outcome: Length of Debond Appointment

Time frame: 1 day. Mean (Standard Deviation). Unit: minutes

Measure	Patients With Malocclusion n = 13
Value	60 (0)

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

Adverse events

Time frame: Patients were evaluated for any adverse events over their treatment, an expected average of 2 years. However, two patients had treatment times over 2 years with the maximum being under 4 years/. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patients With Malocclusion	0 of 14 (0%)	0 of 14 (0%)	0 of 14

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Dental Malocclusion

Enrolling by invitation
Discision as Acceleration Method in Canine Retraction in Orthodontics With Aligner and Fixed Appliances in Young Adults a Split Mouth Study
Bimaxillary Protrusion, Class II Div 1 Malocclusion
Recruiting
Assessment of the Locally Administrated Vitamin D3 and Corticision Efficacy on Orthodontic Canine Retraction
Malocclusions, Canine Retraction
Not yet recruiting
Timing, Trajectories and Prediction in Severe Dental Crowding: The Create SPACE (cSPACE)
Crowding of Teeth, Malocclusion; Displaced Teeth
Recruiting
FM Technique in Orthodontic Clear Aligner Therapy: A Single-Arm Clinical Study
Malocclusion
Not yet recruiting
Treatment of Mandibular Overjet in Children With Maxillary Retrognathism
Maxillary Retrognathism, Children

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kelsey Fafara, BS study director

LightForce Orthodontics

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing LightForce Orthodontic System in people with Dental Malocclusion, run by LightForce Orthodontics at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Length of Bonding Appointment (time frame: 1 day). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04266769.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.