Clinical Performance of a New Esthetic, Self-ligating Orthodontic Bracket

University of Minnesota (UMN)

Status: Completed

Conditions: Malocclusion

Treatments: Device: Lower Anterior EXD-952 Self-ligating Brackets

Study type: Interventional

Funder types: Other

Identifiers

NCT02959671

1611M00321

Details and patient eligibility

About

A cohort of 15 patients starting orthodontic treatment with fixed appliances will receive EXD-952 Ceramic Self-ligating brackets on all mandibular incisors and a different type of brackets on the remaining mandibular teeth. Tooth movement will be initiated using 0.014" or 0.016" Nickel-Titanium archwires.

A second cohort of 15 patients will receive EXD-952 Ceramic Self-ligating bracket on all mandibular incisors in a later phase of their ongoing orthodontic treatment. The mandibular incisor brackets will be removed and EXD-952 Ceramic Self-ligating brackets placed instead. Other mandibular brackets will remain in place. Tooth movement will be performed using 0.019x0.025" Stainless Steel archwires.

In both cohorts bracket door stability, the ability of the door to hold the archwire in the bracket slot, the bracket's ability to rotate teeth, clinicians' satisfaction with the bracket, and patient comfort in comparison with other brackets will be assessed.

The evaluation for each patient will last for at least until one archwire change (cohort 1) or one appointment interval (6-8 weeks, cohort 2).

After the evaluation period, EXD-952 Ceramic Self-ligating brackets will remain in place until the orthodontic treatment is completed.

Enrollment: 34 patients

Sex: All

Ages: 10+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Permanent mandibular dentition including incisors, canines, premolars, and first molars (includes subjects treated with the extraction of premolars)
• Mandibular incisors with sound, non-carious buccal enamel and no pretreatment with chemical agents such as hydrogen peroxide

Exclusion criteria

• Mental/emotional/developmental disability
• Inability to give informed consent
• Cleft lip and/or palate, craniofacial anomaly, or syndrome
• Obvious oral hygiene issues such as excessive plaque accumulation, gingivitis, and/or pre-existing white spot lesions
• Prosthodontic or restored substrate extending on the labial surface of mandibular incisors
• Deep bite
• Known allergies to any study materials

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

Lower Anterior EXD-952 Self-ligating Brackets

Experimental group

Treatment:

Device: Lower Anterior EXD-952 Self-ligating Brackets