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N/A N=34 Treatment

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

Malocclusion

Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Bracket Door Stability — 0.8 percentage of bracket doors

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Lower Anterior EXD-952 Self-ligating Brackets (Device)
Age
Pediatric, Adult, Older Adult · 10+ yrs
Sex
All
Sponsor
University of Minnesota
Primary completion
Jan 2020

Outcome Measures

OutcomeResultp-value
PRIMARY
Bracket Door Stability
0.8
PRIMARY
Ability of Door to Successfully Hold the Archwire in the Bracket Slot
96
PRIMARY
Bracket's Ability to Rotate Teeth
62.5
PRIMARY
Clinicians' Satisfaction With the Bracket
70
PRIMARY
Patient Comfort in Comparison With Other Brackets (Questionnaire)
84

Summary

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02959671). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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