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.
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.
This clinical trial aims to investigate if there are differences in the failure rates of stainless steel and ceramic orthodontic brackets. Patients willing to start orthodontic fixed therapy and recruited for the study will be asked to sign the informed consent. Parents will sign the consent for underage patients. After that, patients will be divided into two groups: - Group MET: stainless steel brackets will be bonded on the vestibular surfaces of teeth. - Group CER: ceramic brackets will be bonded on the vestibular surfaces of teeth. The following sequence of archwires will be adopted for the first six months: 0.012-in Niti, 0.014-in Niti, 0.016-in NiTi, 0.018 SS Australian, 0.020 SS Australian, 0.017X0.025-in NiTi, 0.019X0.025-in SS. The failure rates of the brackets will be recorded each month for 12 months. Each failed bracket will be recorded once. For each patient, pre-treatment lateral cephalometric radiograph and study models will be used to measure ANB angle, Wits, Skeletal Class, dento-alveolar discrepancy and Little Index at the beginning of the treatment. Bond failures will be recorded together with the archwire engaged at the moment of the failure. Sample size Sample size was calculated with the following assumptions: ability to detect a clinically relevant difference of 4.935% in the failure rates (primary outcome) of the two groups with an alfa = 0.05 and power = 80%. The assumptions were based on findings of a previous study with an expected value of 12.08% for the first group at the end of 12 months of therapy. Therefore, 800 brackets (40 patients) per group were required for the study. Statistical analysis Statistical analysis will be conducted with R software (R version 3.1.3, R Development Core Team, R Foundation for Statistical Computing, Wien, Austria). Fisher exact test will be performed to evaluate the differences between the failure rates of the two groups, between anterior and posterior sites and between upper and lower arches. Kaplan-Meier survival analysis of the bond failures will be performed among the 12 months of the study. Linear regressions will be calculated to assess the effects on bond failure of the skeletal and dental variables collected before the bonding procedure. Significance for all statistical tests will be predetermined at P<0.05. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04713280 -
Maxillary Versus Bi-Maxillary Posterior Segments Intrusion Adult Subjects With Skeletal Open Bite
|
N/A | |
Completed |
NCT04387578 -
Evaluation of Efficiency for Three Different Aligning Archwires During Initial Orthodontic Leveling
|
N/A | |
Completed |
NCT03991221 -
Validation of Dental Malocclusion Schematic Representations for Early Orthodontic Treatment
|
N/A | |
Completed |
NCT04381442 -
Effect of Low Level Laser on Orthodontic Canine Retraction
|
N/A | |
Completed |
NCT05614635 -
Safety and Technical Performance of Plastalgin and Plastalgin Fast in Patients Requiring a Dental Impression
|
||
Recruiting |
NCT03714932 -
Accuracy of Arch Analysis in Mixed Dentition Using Digital Models Versus Plaster Ones.
|
||
Completed |
NCT05094973 -
Predictability of Distalization and Derotation of the Carriere Motion Appliance.
|
N/A | |
Completed |
NCT05831722 -
Changes in the Upper Airway Volume After Rapid Maxillary Expansion in Adults Using Pure Skeletal Anchorage
|
||
Active, not recruiting |
NCT05896618 -
Evaluation of Dental and Skeletal Effect of TPA and Nance as a Space Maintainers in Children: A Prospective Clinical Trial
|
N/A | |
Recruiting |
NCT04828096 -
Retention With Three Different Bonded Retainers a Multicenter, Randomized Controlled Trial With 5-year Follow-up
|
N/A | |
Completed |
NCT04955860 -
Evaluation of First Molar Inclinations and Transverse Arch Width in Individuals With Posterior Crossbite
|
||
Recruiting |
NCT06278116 -
Comparison of Absorbance Values, Sensory Evaluations and Periodontal Effects of Five Different Products for Clean Aligners Cleansing
|
N/A | |
Completed |
NCT04631419 -
Effects of Flapless Laser Corticotomy in Canine Retraction
|
N/A | |
Completed |
NCT04347018 -
BRIUS Vs FFA Efficiency
|
N/A | |
Recruiting |
NCT05615688 -
Pain and Activity Levels After Orthodontic Separators
|
N/A | |
Completed |
NCT04376164 -
Laser in Orthodontic Leveling and Alignment
|
N/A | |
Completed |
NCT04266769 -
Precision Orthodontics: A Comparison of Custom vs Traditional Bracket Treatment Efficiency
|
N/A | |
Enrolling by invitation |
NCT05144555 -
Periodontal Parameters in Orthodontic Patients With Stainless Steel and Ceramic Brackets.
|
N/A | |
Completed |
NCT05939102 -
Eighteen-month Orthodontic Bracket Survival Rate With the Conventional Bonding Technique Versus RMGIC and V-prep
|
N/A | |
Recruiting |
NCT05978856 -
The Accuracy of Computer Software Prediction of Soft Tissue Profile for Patients Undergoing Fixed Orthodontic Treatment
|