RecruitingACTRN12624001211550

A comparison of LightForce vs conventional orthodontic brackets in initial lower arch alignment efficiency and discomfort: a randomised clinical trial

A comparison of LightForce vs conventional preadjusted brackets in initial mandibular alignment efficiency and discomfort: a randomised clinical trial in 11 to 21 year old patients


Sponsor

The University of Queensland

Enrollment

60 participants

Start Date

Apr 10, 2025

Study Type

Interventional

Conditions

Summary

The purpose of this trial is to compare the improvement of lower dental crowding and patient discomfort in the initial stages orthodontic treatment using conventional preadjusted orthodontic brackets (3M Victory and Clarity, MBT Prescription 022 slot) vs custom LightForce brackets (LightForce Orthodontics, Custom Prescription 022 slot). The primary outcome measured will be change in mandibular Little’s Irregularity Index (LII ) which assesses crowding over a set time period of 12 weeks. The null hypothesis is that there is no difference in the rate of change of lower incisor crowding in the first 12 weeks when using LightForce or conventional preadjusted brackets. The secondary outcomes will include time to reach the first rectangular nickel titanium (NiTi) archwire and evaluation of patient discomfort.


Eligibility

Sex: Both males and femalesMin Age: 11 YearssMax Age: 21 Yearss

Plain Language Summary

Simplified for easier understanding

Dental braces work by applying gentle, continuous forces to move teeth into their correct positions. Traditional brackets are mass-produced, while LightForce brackets are custom-designed using 3D printing technology to fit each individual tooth precisely. The idea is that custom brackets might move teeth more efficiently in the early stages of treatment, potentially reducing treatment time and discomfort for patients. This randomised trial will compare how quickly crowded lower teeth are straightened over the first 12 weeks of treatment using either conventional brackets or LightForce custom brackets. Patient-reported pain and discomfort will also be compared between the two groups. You may be eligible if you are 11 to 21 years old, are starting fixed orthodontic treatment (braces), have a full permanent set of teeth (excluding wisdom teeth), and have significant crowding in your lower jaw (at least 5mm measured on a standard scale). People planning orthognathic (jaw) surgery, with impacted canines or premolars, on medications that affect tooth movement, or with missing lower front teeth are not eligible. This study could help determine whether the extra investment in custom brackets is worthwhile.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

The use of LightForce (LightForce Orthodontics, .018 Slot with .022 Slot molar tubes) brackets for the entire duration of fixed orthodontic treatment. Duration of wear is 24 hours a day. The bracket

The use of LightForce (LightForce Orthodontics, .018 Slot with .022 Slot molar tubes) brackets for the entire duration of fixed orthodontic treatment. Duration of wear is 24 hours a day. The brackets will be administered by two registered orthodontists in a single private practive setting in Queensland. The brackets will be adjusted and checked every 8-12 weeks, and broken ones replaced, however patients may present earler as an emergency bracket reattachment appointment. Assessing adherence to the intervention is not critical as the brackets are firmly attached to the teeth.


Locations(1)

QLD, Australia

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ACTRN12624001211550


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