Comparison Between Clear Aligners and Traditional Fixed Appliances in the Treatment of Four-premolar-extraction Cases
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|ClinicalTrials.gov Identifier: NCT03645356|
Recruitment Status : Recruiting
First Posted : August 24, 2018
Last Update Posted : August 29, 2018
Patients who have severe crowding that require four premolars extraction will be treated in this study. The efficacy of the clear aligners and vestibular fixed appliances will be assessed. The treatment result of these two different methods will be explored using the Peer Assessment Rating (PAR) in two different times (T0: Before treatment, T1: After treatment) and the American Board of Orthodontics Objective Grading System (ABO-OGS) after treatment (T1).
There are two groups:
First group (Experimental): the patients in this group will be treated using clear aligners.
Second group (Control): the patients in this group will be treated using fixed appliances.
|Condition or disease||Intervention/treatment||Phase|
|Malocclusion, Angle Class I Malocclusion; Displaced or Missing Teeth Crowding||Device: Fixed Appliances Device: Clear Aligners||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Evaluation of the Efficacy of Clear Aligners in the Correction of Severe Dental Crowding Cases Combined With Premolar Extraction Versus Vestibular Fixed Orthodontic Appliances: A Randomized Clinical Controlled Trial|
|Actual Study Start Date :||August 19, 2018|
|Estimated Primary Completion Date :||June 10, 2019|
|Estimated Study Completion Date :||January 20, 2021|
Active Comparator: fixed appliances
patients will be treated using fixed appliances in order to align their teeth after extraction of four premolars
Device: Fixed Appliances
Using an MBT-prescription of metallic brackets, patients will be treated in the conventional way
Experimental: clear aligners
patients will be treated using clear aligners in order to align their teeth after extraction of four premolars
Device: Clear Aligners
Using a sequence of clear aligners, patients will be give an aligner every two weeks until the completion of treatment
- Change in PAR index [ Time Frame: T1: one day before the commencement of treatment. T2: one day following the end of treatment (that is expected to happen within 24 months) ]The PAR index will be used to provide objective assessment of treatment success. Each set of dental models prepared before and after treatment for each case will be occluded in maximum intercuspation and a calibrated PAR ruler is used to assign a value to each of the PAR index components: contact displacement in the upper and lower labial segment (UAS), overjet (OJ), overbite (OB), medline deviation (MID) and right and left buccal occlusion (RBO, LBO). Then the weighted PAR index score will be calculated according to the American wightining system as follows: UAS times 1, RBO and LBO times 2, OJ and OB times 3 and MID times 2. A perfect occlusion would receive a score of zero, a score from one to nine indicates that good dental relationships are present; a score above 40 indicates severe malocclusion.
- Change in the American Board of Orthodontics - Objective Grading System (ABO-OGS): [ Time Frame: T1: one day before the commencement of treatment. T2: one day following the end of treatment (that is expected to happen within 24 months) ]
Eight domains are evaluated:
Alignment: No more than 2 points shall be subtracted for any tooth when it is poorly aligned; Marginal Ridges: The total number of deductions shall be subtracted from 32 to give the score for this domain; Buccolingual inclination: If the mandibular lingual cusps or maxillary buccal cusps are more than 1 mm from the straight edge surface, 1 point shall be subtracted for that tooth; Occlusal Contacts: If a cusp is out of contact with the opposing arch, 1 point is subtracted for that tooth; Occlusal relationships. The total number of deductions are subtracted from 24 to give the score for occlusal relationships; Overjet; Interproximal contacts. If no interproximal spaces exist, then no points are subtracted; and Root angulation: Any deviations in roots' angulations will cause a deduction form the general score. Finally, a case that loses more than 30 points will be considered a failure. A case that loses less than 20 points will be considered acceptable.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03645356
|Contact: Samer T Jaber, DDS MScfirstname.lastname@example.org|
|Contact: Mohammad Y Hajeer, DDS MSc PhDemail@example.com|
|Syrian Arab Republic|
|Department of Orthodontics, University of Damascus Dental School||Recruiting|
|Damascus, Syrian Arab Republic, DM20AM18|
|Contact: Mohammad Y Hajeer, DDS MSc PhD +963940404840 firstname.lastname@example.org|
|Principal Investigator: Samer T Jaber, DDS MSc|
|Principal Investigator:||Samer T Jaber, DDS MSc||PhD Student in Orthodontics, University of Damascus Dental School, Damascus|
|Study Chair:||Mohammad Y Hajeer, DDS MSc PhD||Associate Professor of Orthodontics, University of Damascus Dental School, Damascus, Syria|