Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06631131
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-27
Brief Title:
Distalization With Aligners Anchorage Options
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of the Dentoskeletal Effects of Maxillary Molar Distalization With Clear Aligners Class II Elastic Anchorage vs Miniscrew Anchorage
Status:
COMPLETED
Status Verified Date:
2024-10
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:
Background To compare the dentoskeletal effects of Class II elastic anchorage and infrazygomatic crest IZC miniscrew anchorage in sequential maxillary molar distalization using clear aligners
Methods A total of 22 patients with Angle Class II malocclusion treated with clear aligners and maxillary molar distalization were included Based on the anchorage method patients were divided into two groups Class II elastics Group 1 or IZC miniscrews Group 2 Lateral cephalometric radiographs and digital models were obtained from all patients before treatment T0 and after distalization of the second premolars T1 to assess skeletal and dental changes Geomagic Control X was used to superimpose the digital models
Methods A total of 22 patients with Angle Class II malocclusion treated with clear aligners and maxillary molar distalization were included Based on the anchorage method patients were divided into two groups Class II elastics Group 1 or IZC miniscrews Group 2 Lateral cephalometric radiographs and digital models were obtained from all patients before treatment T0 and after distalization of the second premolars T1 to assess skeletal and dental changes Geomagic Control X was used to superimpose the digital models
Detailed Description:
The data for this study were obtained from patients who presented for treatment at the Department of Orthodontics at Bezmialem Vakif University Faculty of Dentistry All patients were treated with clear aligners Invisalign Align Technology CA USA at Bezmialem University Hospital Sequential distalization 50 was planned in the maxillary arch For each aligner a staging of 025 mm was determined Distalization starts with the second molars then the first molars after half of the second molar movement is completed and finally the premolars In the ClinCheck planning 3 or 4 mm vertical rectangular attachments were placed from the second molar to the canine and were bevelled mesially to enhance the distalization forces The patients were divided into two groups those who were treated with sequential distalization with aligners supported by Class II elastics group 1 or IZC miniscrews group 2 In group 1 with the beginning of the movement of the upper first molars Class II intermaxillary elastics were used from precision cuts of the upper canines to the buttons on the lower first molars In group 2 IZC miniscrews were inserted in the IZC region between the upper molars in both sides before first molar movement started The same intramaxillary elastics were used from precision cuts of the upper canines to the IZC miniscrew The use of intraintermaxillary elastics was started with the initiation of upper first molar movement to prevent anchorage loss and maxillary incisor proclination Both groups were instructed to wear the elastics and aligners a minimum of 22 hours per day using a 10-day aligner wear protocol Maxillary third molars were extracted before treatment
Patients were scanned by iTero 5D Element intraoral scanner and radiographs were taken before treatment T0 and after distalization of the second premolar T1
Cephalometric radiographs were obtained from all patients and these radiographs were used for two-dimensional measurementsDigital tracing and measurements of the cephalometric radiographs were performed using NemoCeph version 60 software Angular dental measurements were performed between the long axis of the teeth and the sella-nasion S-N plane using Image J software The long axis was determined as a line through the incisal edge and the root apex for the incisors through the buccal cusp tip and the root apex for the premolars and through the centroid and the furcation for the molars Digital models were exported from OrthoCAD software as stereolithography STL files and imported into Geomagic Control X software for three-dimensional 3D model comparison All digital models were superimposed using the local best fit algorithm A reference area in the palatal region was used for the model superimposition and 50 iteration points were defined in this area for the superimpositions
After model superimposition reference points of the teeth were selected on the two models to enable linear measurements These points were the mesiobuccal cusp tips of the maxillary molars and the buccal cusp tips of the premolars These reference points were marked on the T0 and T1 models and measurements were taken to observe changes on all three axis In linear measurements
1 X-axis represent buccolingual transversal differences X in the buccal direction and X- in the palatal direction
2 Y-axis represent mesiodistal sagittal differences Y in the distal direction and Y- in the mesial direction and
3 Z-axis represent vertical differences Z indicating extrusion and Z- indicating intrusion
For angular measurements reference points and vectors were identified on 3D models These points were the mesiobuccal and mesiopalatal cusp tips of the molars and the buccal and palatal cusp tips of the premolars The angles between reference vectors were measured Rotational movements were measured using the XY-axis with positive values indicating mesiobuccal rotation and negative values indicating distobuccal rotation
Patients were scanned by iTero 5D Element intraoral scanner and radiographs were taken before treatment T0 and after distalization of the second premolar T1
Cephalometric radiographs were obtained from all patients and these radiographs were used for two-dimensional measurementsDigital tracing and measurements of the cephalometric radiographs were performed using NemoCeph version 60 software Angular dental measurements were performed between the long axis of the teeth and the sella-nasion S-N plane using Image J software The long axis was determined as a line through the incisal edge and the root apex for the incisors through the buccal cusp tip and the root apex for the premolars and through the centroid and the furcation for the molars Digital models were exported from OrthoCAD software as stereolithography STL files and imported into Geomagic Control X software for three-dimensional 3D model comparison All digital models were superimposed using the local best fit algorithm A reference area in the palatal region was used for the model superimposition and 50 iteration points were defined in this area for the superimpositions
After model superimposition reference points of the teeth were selected on the two models to enable linear measurements These points were the mesiobuccal cusp tips of the maxillary molars and the buccal cusp tips of the premolars These reference points were marked on the T0 and T1 models and measurements were taken to observe changes on all three axis In linear measurements
1 X-axis represent buccolingual transversal differences X in the buccal direction and X- in the palatal direction
2 Y-axis represent mesiodistal sagittal differences Y in the distal direction and Y- in the mesial direction and
3 Z-axis represent vertical differences Z indicating extrusion and Z- indicating intrusion
For angular measurements reference points and vectors were identified on 3D models These points were the mesiobuccal and mesiopalatal cusp tips of the molars and the buccal and palatal cusp tips of the premolars The angles between reference vectors were measured Rotational movements were measured using the XY-axis with positive values indicating mesiobuccal rotation and negative values indicating distobuccal rotation
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