Clinical trial NCT03903575: 3D Comparison of Anterior Teeth Retraction and Anchorage Control Between En-masse and Two-step Mechanics
Official title: 3D Comparison of Anterior Teeth Retraction and Anchorage Control Between En-masse and Two-step Mechanics: A Randomized Prospective Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Malocclusion, Angle Class I
Bimaxillary Protrusion
Orthodontic Space Closure
Lead sponsor: Rio de Janeiro State University
Sponsor class: OTHER
Collaborators: name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2019-04-04
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


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;

Primary outcomes:
measure: Anchorage loss
timeFrame: 12 months
measure: Anterior teeth retraction
timeFrame: 12 months
Secondary outcomes:
measure: Molar inclination
timeFrame: 12 months
measure: Canine inclination
timeFrame: 12 months
measure: Incisors inclination
timeFrame: 12 months
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Faculdade de Odontologia - UERJ
Study officials:
affiliation: Rio de Janeiro State University
name: Sergio Caetano, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Rio de Janeiro State University
name: Flavia Artese, PhD
role: STUDY_DIRECTOR
affiliation: Rio de Janeiro State University
name: Jose Augusto M Miguel, PhD
role: STUDY_CHAIR
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