Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06504498
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-06-28
Brief Title:
Effectiveness of Clear Aligners in Different Thicknesses
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effectiveness of Orthodontic Treatment With Clear Aligners in Different Thicknesses
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aimed to evaluate the effectiveness pain and satisfaction levels between patients treated with different thicknesses of clear aligners among Class I maxillary mild crowding cases Two types of clear aligners with thicknesses of 05 and 075 mm were used The null hypotheses were as follows There is no clinical difference in effectiveness pain and satisfaction levels between different thickness of clear aligners The alternate hypotheses were as follows The thicker the clear aligner the greater orthodontic force applied to tooth which affects the amount of orthodontic tooth movement pain and satisfaction levels of patients The primary aim was to evaluate pre- and post-treatment changes in amount of orthodontic tooth movement Maxillary cephalometric parameters were measured on lateral cephalograms and maxillary dental parameters were measured using OrthoAnalyzer and compared before and after treatment Visual Analogue Scale and Patient Satisfaction Evaluation Form were used in order to assess the pain and satisfaction levels of patients Pain and satisfaction levels were measured before the aligner insertion T0 at the 4th hour T1 2nd day T2 1st week T3 1st month T4 and at the end of the treatment T5
Detailed Description:
The sample size was computed to detect difference in the amount of orthodontic tooth movement between groups GPower University of Dusseldorf Germany The calculated sample size was 14 for each group similar to the previously published study effect size 08 α 005 and 1 - β 080 Lateral cephalograms were taken for all patients using the X-ray device PM 2002 EC Proline Planmeca OY Helsinki Finland in the Department of Oral and Maxillofacial Radiology Patients who satisfied the inclusion criteria were enrolled in this study and they were randomly separated into 2 groups Group 1 and Group 2 based on the aligner thickness each consisted of 14 patients Patients in Group 1 were treated with 05 mm-thick clear aligners patients in Group 2 were treated with 075 mm-thick clear aligners The Littles Irregularity Index were calculated using OrthoAnalyzer software 3Shape Copenhagen Denmark to standardize the amount of maxillary anterior crowding at the beginning of the treatment Initial records were taken at the beginning of the treatment using an intraoral scanner Trios 3 3Shape Copenhagen Denmark Scanned data has been converted to standard tessellation language STL files and these files have been modified to create virtual setups for orthodontic tooth movement using OrthoAnalyzer software Virtual setups were imported into a slicing software for model preparation before printing A stereolithographic SLA 3D printer and liquid photopolymer were used to print resin models These models were used as mould for thermoforming of the aligners using a vacuum-thermoforming machine Model No 202 Keystone Industries Myerstown USA All aligners were manually cut with straight trim lines at gingival zenith to provide better comfort for the patients Attachments were placed according to the software and interproximal reductions were performed by the same operator SMC Patients were followed at 2nd day T2 1st week T3 1st month T4 and at the end of the treatment T5 Pre- T0 and post-treatment T5 digital models lateral cephalometric radiographs were compared Pain and satisfaction levels of patients were assessed using Visual Analogue Scale and Patient Satisfaction Evaluation Form
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None