Skip to content

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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03903575
Enrollment
32
Registered
2019-04-04
Start date
2019-04-03
Completion date
2020-12-31
Last updated
2019-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bimaxillary Protrusion, Malocclusion, Angle Class I, Orthodontic Space Closure

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.

Interventions

PROCEDUREEn 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.

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.

Sponsors

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
CollaboratorOTHER_GOV
Rio de Janeiro State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

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;

Design outcomes

Primary

MeasureTime frameDescription
Anchorage loss12 monthsQuantitative assessment of posterior anchorage loss between the two groups as measured by tomographic superimposition at the end of space closure.
Anterior teeth retraction12 monthsQuantitative assessment of anterior teeth retraction between the two groups as measured by tomographic superimposition at the end of space closure.

Secondary

MeasureTime frameDescription
Molar inclination12 monthsQuantitative assessment of molars inclination between the two groups as measured by tomographic superimposition at the end of space closure.
Canine inclination12 monthsQuantitative assessment of canines inclination between the two groups as measured by tomographic superimposition at the end of space closure.
Incisors inclination12 monthsQuantitative assessment of incisors inclination between the two groups as measured by tomographic superimposition at the end of space closure.

Countries

Brazil

Contacts

Primary ContactSergio Caetano, MSc
srocaetano@hotmail.com+55(21)97912-5679
Backup ContactFlavia Artese, PhD
flaviaartese@gmail.com+55(21)98155-4280

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026