Dental Malocclusion Clinical Trial
Official title:
A 12-months Evaluation of the Failure Rates of Stainless Steel and Ceramic Brackets in Orthodontic Fixed Therapy: a Clinical Trial.
Verified date | January 2024 |
Source | University of Pavia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study is to assess if there are significant differences in the failure rate of stainless steel and ceramic brackets. For this study, patients will be enrolled and divided into two groups, according to the type of brackets (stainless steel or ceramic) used for orthodontic treatment. Failure rates will be recorded every month for 12 months and survival analysis will be performed, together with skeletal and space analysis.
Status | Completed |
Enrollment | 80 |
Est. completion date | May 8, 2023 |
Est. primary completion date | May 4, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - patients willing to begin fixed multibracket therapy with metallic or ceramic brackets; - full permanent dentition; - enamel integrity, absence of traumatic or carious lesions, no pretreatment procedure performed with chemical agents; - no previous orthodontic treatment with fixed vestibular appliances. Exclusion Criteria: - patients suffering from systemic diseases; - patients taking medications that could alter periodontal conditions (NSAIDS, steroids, etc.); - patients with low compliance; - patients unable to give informed consent; - presence of congenital enamel defects; - extractions for orthodontic reasons; - oral/orthognathic surgery. |
Country | Name | City | State |
---|---|---|---|
Italy | Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia | Pavia | Lombardy |
Lead Sponsor | Collaborator |
---|---|
University of Pavia |
Italy,
Kirschneck C, Rohn C, Proff P, Reicheneder C. Influence of enamel sealing with a light-cured filled sealant before bracket bonding on the bond failure rate during fixed orthodontic therapy. J Orofac Orthop. 2019 May;80(3):136-143. doi: 10.1007/s00056-019-00174-w. Epub 2019 Apr 10. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Failure rates of metallic and ceramic brackets. | Each month, failed brackets will be recorded. Per each tooth, failure will be recorded once. | Among the 12 months of the study. | |
Secondary | Failure rates of metallic and ceramic brackets per sites and sides. | Failures will be divided in "anterior" for brackets failed on incisors and canines, and "posterior" for premolar brackets. Failure will be recorded per dental arch ("upper" and "lower") and per archwire (.014-in NiTi, .016-in NiTi, .017X0.25-in NiTi, .019X.025-in SS). Per each tooth, failure will be recorded once. | Among the 12 months of the study. | |
Secondary | ANB angle | ANB angle will be calculated using the pre-treatment lateral cephalometric radiograph. | Before the beginning of the orthodontic treatment. | |
Secondary | Wits Index | Wits Index will be calculated using the pre-treatment lateral cephalometric radiograph. | Before the beginning of the orthodontic treatment. | |
Secondary | Skeletal Class | Skeletal Class will be assessed using ANB angle and Wits Index will be calculated using the pre-treatment lateral cephalometric radiograph. | Before the beginning of the orthodontic treatment. | |
Secondary | Dento-alveolar discrepancy | Dento-alveolar discrepancy will be calculated using the pre-treatment study models. | Before the beginning of the orthodontic treatment. | |
Secondary | Little Index | Little Index will be calculated using the pre-treatment study models. | Before the beginning of the orthodontic treatment. |
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