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

NCT ID: NCT03903575

Last Updated: 2019-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-03

Study Completion Date

2020-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Malocclusion, Angle Class I Bimaxillary Protrusion Orthodontic Space Closure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

En Masse Retraction

Group treated by retracting the six anterior teeth simultaneously.

Group Type EXPERIMENTAL

En masse anterior teeth retraction

Intervention Type PROCEDURE

After extraction of the four premolars the posterior teeth will be tied-together and the six anterior teeth will be retracted by sliding mechanics.

Two-Step Retraction

Group treated by retracting the canines incisors in two different steps.

Group Type ACTIVE_COMPARATOR

Two-Step Retraction

Intervention Type PROCEDURE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

OTHER_GOV

Sponsor Role collaborator

Rio de Janeiro State University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sergio Roberto de Oliveira Caetano

Masters in Orthodontics, PhD Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sergio Caetano, MSc

Role: PRINCIPAL_INVESTIGATOR

Rio de Janeiro State University

Flavia Artese, PhD

Role: STUDY_DIRECTOR

Rio de Janeiro State University

Jose Augusto M Miguel, PhD

Role: STUDY_CHAIR

Rio de Janeiro State University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Faculdade de Odontologia - UERJ

Rio de Janeiro, , Brazil

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Brazil

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Sergio Caetano, MSc

Role: CONTACT

+55(21)97912-5679

Flavia Artese, PhD

Role: CONTACT

+55(21)98155-4280

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Sergio Caetano, MSc

Role: primary

+55(21)97912-5679

Flavia Artese, PhD

Role: backup

+55(21)98155-4280

References

Explore related publications, articles, or registry entries linked to this study.

Heo W, Nahm DS, Baek SH. En masse retraction and two-step retraction of maxillary anterior teeth in adult Class I women. A comparison of anchorage loss. Angle Orthod. 2007 Nov;77(6):973-8. doi: 10.2319/111706-464.1.

Reference Type BACKGROUND
PMID: 18004930 (View on PubMed)

Xu TM, Zhang X, Oh HS, Boyd RL, Korn EL, Baumrind S. Randomized clinical trial comparing control of maxillary anchorage with 2 retraction techniques. Am J Orthod Dentofacial Orthop. 2010 Nov;138(5):544.e1-9; discussion 544-5. doi: 10.1016/j.ajodo.2009.12.027.

Reference Type BACKGROUND
PMID: 21055588 (View on PubMed)

Schneider PP, Gandini Junior LG, Monini ADC, Pinto ADS, Kim KB. Comparison of anterior retraction and anchorage control between en masse retraction and two-step retraction: A randomized prospective clinical trial. Angle Orthod. 2019 Mar;89(2):190-199. doi: 10.2319/051518-363.1. Epub 2018 Nov 26.

Reference Type BACKGROUND
PMID: 30475647 (View on PubMed)

Leonardi R, Annunziata A, Licciardello V, Barbato E. Soft tissue changes following the extraction of premolars in nongrowing patients with bimaxillary protrusion. A systematic review. Angle Orthod. 2010 Jan;80(1):211-6. doi: 10.2319/010709-16.1.

Reference Type BACKGROUND
PMID: 19852663 (View on PubMed)

Kojima Y, Fukui H. Numerical simulation of canine retraction by sliding mechanics. Am J Orthod Dentofacial Orthop. 2005 May;127(5):542-51. doi: 10.1016/j.ajodo.2004.12.007.

Reference Type BACKGROUND
PMID: 15877034 (View on PubMed)

Bennett JC, McLaughlin RP. Controlled space closure with a preadjusted appliance system. J Clin Orthod. 1990 Apr;24(4):251-60. No abstract available.

Reference Type BACKGROUND
PMID: 2094736 (View on PubMed)

Ribeiro GL, Jacob HB. Understanding the basis of space closure in Orthodontics for a more efficient orthodontic treatment. Dental Press J Orthod. 2016 Mar-Apr;21(2):115-25. doi: 10.1590/2177-6709.21.2.115-125.sar.

Reference Type BACKGROUND
PMID: 27275623 (View on PubMed)

Pervin S, Rolland S, Taylor G. En masse versus two-step retraction of the anterior segment. Evid Based Dent. 2018 Dec;19(4):111-112. doi: 10.1038/sj.ebd.6401343.

Reference Type BACKGROUND
PMID: 30573856 (View on PubMed)

Rizk MZ, Mohammed H, Ismael O, Bearn DR. Effectiveness of en masse versus two-step retraction: a systematic review and meta-analysis. Prog Orthod. 2018 Jan 5;18(1):41. doi: 10.1186/s40510-017-0196-7.

Reference Type BACKGROUND
PMID: 29302879 (View on PubMed)

Cevidanes LH, Bailey LJ, Tucker GR Jr, Styner MA, Mol A, Phillips CL, Proffit WR, Turvey T. Superimposition of 3D cone-beam CT models of orthognathic surgery patients. Dentomaxillofac Radiol. 2005 Nov;34(6):369-75. doi: 10.1259/dmfr/17102411.

Reference Type BACKGROUND
PMID: 16227481 (View on PubMed)

Cevidanes LH, Styner MA, Proffit WR. Image analysis and superimposition of 3-dimensional cone-beam computed tomography models. Am J Orthod Dentofacial Orthop. 2006 May;129(5):611-8. doi: 10.1016/j.ajodo.2005.12.008.

Reference Type BACKGROUND
PMID: 16679201 (View on PubMed)

Feldmann I, Bondemark L. Orthodontic anchorage: a systematic review. Angle Orthod. 2006 May;76(3):493-501. doi: 10.1043/0003-3219(2006)076[0493:OA]2.0.CO;2.

Reference Type BACKGROUND
PMID: 16637733 (View on PubMed)

Geron S, Shpack N, Kandos S, Davidovitch M, Vardimon AD. Anchorage loss--a multifactorial response. Angle Orthod. 2003 Dec;73(6):730-7. doi: 10.1043/0003-3219(2003)0732.0.CO;2.

Reference Type BACKGROUND
PMID: 14719740 (View on PubMed)

Domingo-Clerigues M, Montiel-Company JM, Almerich-Silla JM, Garcia-Sanz V, Paredes-Gallardo V, Bellot-Arcis C. Changes in the alveolar bone thickness of maxillary incisors after orthodontic treatment involving extractions - A systematic review and meta-analysis. J Clin Exp Dent. 2019 Jan 1;11(1):e76-e84. doi: 10.4317/jced.55434. eCollection 2019 Jan.

Reference Type BACKGROUND
PMID: 30697398 (View on PubMed)

Keim RG. Space closure and anchorage control. J Clin Orthod. 2013 Mar;47(3):153-4. No abstract available.

Reference Type BACKGROUND
PMID: 23660788 (View on PubMed)

Keim RG. The challenge of bimaxillary protrusion. J Clin Orthod. 2017 Jun;51(6):315-316. No abstract available.

Reference Type BACKGROUND
PMID: 29059058 (View on PubMed)

Liu Y, Olszewski R, Alexandroni ES, Enciso R, Xu T, Mah JK. The validity of in vivo tooth volume determinations from cone-beam computed tomography. Angle Orthod. 2010 Jan;80(1):160-6. doi: 10.2319/121608-639.1.

Reference Type BACKGROUND
PMID: 19852656 (View on PubMed)

Shearn BN, Woods MG. An occlusal and cephalometric analysis of lower first and second premolar extraction effects. Am J Orthod Dentofacial Orthop. 2000 Mar;117(3):351-61. doi: 10.1016/s0889-5406(00)70240-x.

Reference Type BACKGROUND
PMID: 10715095 (View on PubMed)

Ong HB, Woods MG. An occlusal and cephalometric analysis of maxillary first and second premolar extraction effects. Angle Orthod. 2001 Apr;71(2):90-102. doi: 10.1043/0003-3219(2001)0712.0.CO;2.

Reference Type BACKGROUND
PMID: 11302594 (View on PubMed)

Solem RC, Marasco R, Guiterrez-Pulido L, Nielsen I, Kim SH, Nelson G. Three-dimensional soft-tissue and hard-tissue changes in the treatment of bimaxillary protrusion. Am J Orthod Dentofacial Orthop. 2013 Aug;144(2):218-28. doi: 10.1016/j.ajodo.2013.03.018.

Reference Type BACKGROUND
PMID: 23910203 (View on PubMed)

Williams R, Hosila FJ. The effect of different extraction sites upon incisor retraction. Am J Orthod. 1976 Apr;69(4):388-410. doi: 10.1016/0002-9416(76)90208-6.

Reference Type BACKGROUND
PMID: 1062936 (View on PubMed)

Yoshida N, Koga Y, Mimaki N, Kobayashi K. In vivo determination of the centres of resistance of maxillary anterior teeth subjected to retraction forces. Eur J Orthod. 2001 Oct;23(5):529-34. doi: 10.1093/ejo/23.5.529.

Reference Type BACKGROUND
PMID: 11668872 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

04186818.2.0000.5259

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.