An interventional study of 0.5 mm-thick Duran® clear aligner and 0.75 mm-thick Duran® clear aligner in Angle's Class I Malocclusion and Crowding, Tooth, sponsored by Mersin University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-16.
Sponsored by Mersin University · Not applicable, Interventional, and Treatment
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 0.5 and 0.75 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).
The sample size was computed to detect difference in the amount of orthodontic tooth movement between groups (G*Power, University of Dusseldorf, Germany). The calculated sample size was 14 for each group, similar to the previously published study (effect size = 0.8, α = 0.05, and 1 - β = 0.80). 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 0.5 mm-thick clear aligners, patients in Group 2 were treated with 0.75 mm-thick clear aligners. The Little's 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.
35 studies on the registry are indexed under Malocclusion, Angle Class I; 10 are open to participants now.
This study's enrollment of 28 is below the median of 32 across 31 interventional studies indexed under Malocclusion, Angle Class I.
Browse Malocclusion, Angle Class I studies →Mersin University is the lead sponsor of 176 studies on the registry; 45 are open to participants now.
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Exclusion Criteria:
0.5 mm-thick clear aligners (Duran®; Scheu-Dental GmBH, Iserlohn, Germany).
Device: 0.5 mm-thick Duran® clear aligner
0.75 mm-thick clear aligners (Duran®; Scheu-Dental GmBH, Iserlohn, Germany).
Device: 0.75 mm-thick Duran® clear aligner
0.5 mm-thick clear aligner was used for orthodontic treatment.
0.75 mm-thick clear aligner was used for orthodontic treatment.
Radiographic tooth movement
Changes in the amount of maxillary cephalometric parameters using lateral cephalometric radiographs after 6 months.
Time frame: At 6th months
Orthodontic tooth movement
Changes in intercanine, interpremolar, intermolar arch expansions and dental arch perimeter (maxillary dental parameters) using OrthoAnalyzer® software after 6 months.
Time frame: At 6th months
Patients' pain level
Changes in patients' pain level using a 10-cm VAS using ''no pain'' and ''severe pain'' as anchor descriptions at the 4th hours, 2nd days, 1st week, 1st month, and 6th months.
Time frame: At the 4th hours, 2nd days, 1st week, 1st month, and 6th months
Patients' satisfaction level
Changes in patients' satisfaction level using ''Patient Satisfaction Evaluation Form 1'' at the 4th hours, 2nd days, 1st week, 1st month; and using ''Patient Satisfaction Evaluation Form 2'' at the 6th months.
Time frame: At the 4th hours, 2nd days, 1st week, 1st month, and 6th months
Ran from May 2021 to primary completion in Jan 2022, 8 months.
Of 23 interventional studies with no phase under Malocclusion, Angle Class I, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 24. This study's 8 months is below that.
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This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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