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

NCT03903575 | Unknown

• 1 other identifier: 04186818.2.0000.5259
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Anchorage loss

  Quantitative assessment of posterior anchorage loss between the two groups as measured by tomographic superimposition at the end of space closure.

  12 months

• Anterior teeth retraction

  Quantitative assessment of anterior teeth retraction between the two groups as measured by tomographic superimposition at the end of space closure.

  12 months

Secondary Outcomes (3)

• Molar inclination

  12 months

• Canine inclination

  12 months

• Incisors inclination

  12 months

Study Arms (2)

En Masse Retraction

EXPERIMENTAL

Group treated by retracting the six anterior teeth simultaneously.

Procedure: En masse anterior teeth retraction

Two-Step Retraction

ACTIVE COMPARATOR

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

Procedure: Two-Step Retraction

Interventions

En masse anterior teeth retraction 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.

En Masse Retraction

Two-Step Retraction 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.

Two-Step Retraction

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Rio de Janeiro State University: lead
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator

Study Sites (1)

Faculdade de Odontologia - UERJ

Rio de Janeiro, 20551-030, Brazil

RECRUITING

Related Publications (22)

• 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.

  PMID: 18004930 BACKGROUND

• 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.

  PMID: 21055588 BACKGROUND

• 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.

  PMID: 30475647 BACKGROUND

• 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.

  PMID: 19852663 BACKGROUND

• 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.

  PMID: 15877034 BACKGROUND

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

  PMID: 2094736 BACKGROUND

• 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.

  PMID: 27275623 BACKGROUND

• 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.

  PMID: 30573856 BACKGROUND

• 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.

  PMID: 29302879 BACKGROUND

• 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.

  PMID: 16227481 BACKGROUND

• 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.

  PMID: 16679201 BACKGROUND

• 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.

  PMID: 16637733 BACKGROUND

• 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.

  PMID: 14719740 BACKGROUND

• 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.

  PMID: 30697398 BACKGROUND

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

  PMID: 23660788 BACKGROUND

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

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• 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.

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• 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.

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• 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.

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• 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.

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  PMID: 11668872 BACKGROUND

MeSH Terms

Conditions

Malocclusion, Angle Class I

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Sergio Caetano, MSc

  Rio de Janeiro State University

  PRINCIPAL INVESTIGATOR

• Flavia Artese, PhD

  Rio de Janeiro State University

  STUDY DIRECTOR

• Jose Augusto M Miguel, PhD

  Rio de Janeiro State University

  STUDY CHAIR

Central Study Contacts

Sergio Caetano, MSc

CONTACT

+55(21)97912-5679; srocaetano@hotmail.com

Flavia Artese, PhD

CONTACT

+55(21)98155-4280; flaviaartese@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Masters in Orthodontics, PhD Student

Model Details: 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.

Study Record Dates

• First Submitted: April 3, 2019
• First Posted: April 4, 2019
• Study Start: April 3, 2019
• Primary Completion: April 1, 2020
• Study Completion: December 1, 2020
• Last Updated: April 5, 2019

Record last verified: 2019-04

Locations

BR (1)