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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
Sponsor:
Information provided by (Responsible Party):
Damascus University

Brief Summary:

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

Detailed Description:
For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the CAD/CAM technology, clear aligners treat a broader range of cases with greater precision. They consist of a series of plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for about two weeks, then replaced by the next in the series until the final position is achieved.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Orthodontia

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.

  2. 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.




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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Class I malocclusion with severe crowding (more than 5 mm of tooth-size-arch-length-discrepancy).
  • Good oral hygiene and periodontal health.
  • No severe skeletal discrepancy.
  • Normal proclination for the upper and lower incisors.
  • No congenitally missing or extracted teeth (except for the third molars).
  • No history of previous trauma to the maxillofacial region or surgical interventions.

Exclusion Criteria:

  • Bimaxillary dentoalveolar severe protrusion.
  • Previous orthodontic treatment.
  • Subject with psychological abnormalities.
  • Subject with systemic diseases.
  • Subject has known allergy to latex and plastic

Information from the National Library of Medicine

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


Contacts
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Contact: Samer T Jaber, DDS MSc +963966037869 samerjaber1989@hotmail.com
Contact: Mohammad Y Hajeer, DDS MSc PhD +963940404840 myhajeer@gmail.com

Locations
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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    myhajeer@gmail.com   
Principal Investigator: Samer T Jaber, DDS MSc         
Sponsors and Collaborators
Damascus University
Investigators
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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

Publications:
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Responsible Party: Damascus University
ClinicalTrials.gov Identifier: NCT03645356     History of Changes
Other Study ID Numbers: UDDS-Ortho-07-2018
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Tooth Loss
Malocclusion
Anodontia
Malocclusion, Angle Class I
Tooth Diseases
Stomatognathic Diseases
Periodontal Diseases
Mouth Diseases
Tooth Abnormalities
Stomatognathic System Abnormalities
Congenital Abnormalities