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3D Comparison of Anterior Teeth Retraction and Anchorage Control Between En-masse and Two-step Mechanics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03903575
Recruitment Status : Recruiting
First Posted : April 4, 2019
Last Update Posted : April 5, 2019
Sponsor:
Collaborator:
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Information provided by (Responsible Party):
Sergio Roberto de Oliveira Caetano, Rio de Janeiro State University

Brief Summary:
The aim of this study is to compare en masse (EM) and two-step anterior teeth retraction (TSR) evaluated by means of three-dimensional images superimposition. Thirty-two adult patients with bimaxillary protrusion planed for treatment with four first premolar extractions will be enrolled. All patients will be randomly allocated in a 1:1 ratio to either EM (n=16) group or the TSR (n=16) group. Cone bean computed tomography will be taken before and after anterior retraction. A blind observer will construct separate 3D models for maxillary and mandibular surfaces using the anterior cranial fossa to register models of before and after space closing. Quantitative assessment of posterior anchorage loss and amount of anterior teeth retraction are the main outcomes. The secondary outcomes are the inclination of the molars, canines and incisors.

Condition or disease Intervention/treatment Phase
Malocclusion, Angle Class I Bimaxillary Protrusion Orthodontic Space Closure Procedure: En masse anterior teeth retraction Procedure: Two-Step Retraction Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: All 32 patients will be randomly allocated in a 1:1 ratio to either en masse (n=16) group or the two-step anterior retraction (n=16) group.
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 3D Comparison of Anterior Teeth Retraction and Anchorage Control Between En-masse and Two-step Mechanics: A Randomized Prospective Clinical Trial
Actual Study Start Date : April 3, 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: En Masse Retraction
Group treated by retracting the six anterior teeth simultaneously.
Procedure: En masse anterior teeth retraction
After extraction of the four premolars the posterior teeth will be tied-together and the six anterior teeth will be retracted by sliding mechanics.

Active Comparator: Two-Step Retraction
Group treated by retracting the canines incisors in two different steps.
Procedure: Two-Step Retraction
After extraction of the four premolars the posterior teeth will be tied-together and the canines will be retracted by sliding mechanics. After the distalization of the canines they will be tied to the posterior teeth and the incisors will be retracted by sliding mechanics.




Primary Outcome Measures :
  1. Anchorage loss [ Time Frame: 12 months ]
    Quantitative assessment of posterior anchorage loss between the two groups as measured by tomographic superimposition at the end of space closure.

  2. Anterior teeth retraction [ Time Frame: 12 months ]
    Quantitative assessment of anterior teeth retraction between the two groups as measured by tomographic superimposition at the end of space closure.


Secondary Outcome Measures :
  1. Molar inclination [ Time Frame: 12 months ]
    Quantitative assessment of molars inclination between the two groups as measured by tomographic superimposition at the end of space closure.

  2. Canine inclination [ Time Frame: 12 months ]
    Quantitative assessment of canines inclination between the two groups as measured by tomographic superimposition at the end of space closure.

  3. Incisors inclination [ Time Frame: 12 months ]
    Quantitative assessment of incisors inclination between the two groups as measured by tomographic superimposition at the end of space closure.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Angle Class I malocclusion;
  • Bimaxillary protrusion;
  • Convex profile;
  • All natural teeth present in the mouth;
  • Absence of crowding or with negative discrepancy up to 4mm;
  • Absence of vertical and transverse occlusal problems;
  • Good oral health;
  • Good general health.

Exclusion Criteria:

  • Lack of time to attend consultations;
  • Patients with severe systemic and psychological illness;
  • Patients with parafunction (bruxism), reflux or eating disorders;
  • Presence of periodontal disease;

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): NCT03903575


Contacts
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Contact: Sergio Caetano, MSc +55(21)97912-5679 srocaetano@hotmail.com
Contact: Flavia Artese, PhD +55(21)98155-4280 flaviaartese@gmail.com

Locations
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Brazil
Faculdade de Odontologia - UERJ Recruiting
Rio de Janeiro, Brazil, 20551-030
Contact: Sergio Caetano, MSc    +55(21)97912-5679    srocaetano@hotmail.com   
Contact: Flavia Artese, PhD    +55(21)98155-4280    flaviaartese@gmail.com   
Sponsors and Collaborators
Rio de Janeiro State University
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Investigators
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Principal Investigator: Sergio Caetano, MSc Rio de Janeiro State University
Study Director: Flavia Artese, PhD Rio de Janeiro State University
Study Chair: Jose Augusto M Miguel, PhD Rio de Janeiro State University
Publications:

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Responsible Party: Sergio Roberto de Oliveira Caetano, Masters in Orthodontics, PhD Student, Rio de Janeiro State University
ClinicalTrials.gov Identifier: NCT03903575    
Other Study ID Numbers: 04186818.2.0000.5259
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019

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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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Malocclusion
Malocclusion, Angle Class I
Tooth Diseases
Stomatognathic Diseases