Clinical Performance of a New Esthetic, Self-ligating Orthodontic Bracket
| Status: | Recruiting |
|---|---|
| Conditions: | Dental |
| Therapuetic Areas: | Dental / Maxillofacial Surgery |
| Healthy: | No |
| Age Range: | 10 - Any |
| Updated: | 3/22/2019 |
| Start Date: | January 2017 |
| End Date: | January 2020 |
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.
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.
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
We found this trial at
1
site
Minneapolis, Minnesota 55455
(612) 625-5000
Principal Investigator: Thorsten Gruenheid, DDS, PhD
Phone: 612-625-3903
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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