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Clinical Trials/NCT03903575
NCT03903575
Unknown
Not Applicable

3D Comparison of Anterior Teeth Retraction and Anchorage Control Between En-masse and Two-step Mechanics: A Randomized Prospective Clinical Trial

Rio de Janeiro State University1 site in 1 country32 target enrollmentApril 3, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Malocclusion, Angle Class I
Sponsor
Rio de Janeiro State University
Enrollment
32
Locations
1
Primary Endpoint
Anchorage loss
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 3, 2019
End Date
December 2020
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Rio de Janeiro State University
Responsible Party
Principal Investigator
Principal Investigator

Sergio Roberto de Oliveira Caetano

Masters in Orthodontics, PhD Student

Rio de Janeiro State University

Eligibility 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;

Outcomes

Primary Outcomes

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.

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 Outcomes

  • Molar inclination(12 months)
  • Canine inclination(12 months)
  • Incisors inclination(12 months)

Study Sites (1)

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