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

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.

Study Overview

• Status: Unknown
• Conditions: Bimaxillary Protrusion; Malocclusion, Angle Class I; Orthodontic Space Closure
• Intervention / Treatment: Procedure: En masse anterior teeth retraction; Procedure: Two-Step Retraction

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sergio Caetano, MSc; Phone Number: +55(21)97912-5679; Email: srocaetano@hotmail.com
• Study Contact Backup: Name: Flavia Artese, PhD; Phone Number: +55(21)98155-4280; Email: flaviaartese@gmail.com

Study Locations

• Brazil
  • Rio de Janeiro, Brazil, 20551-030
    • Recruiting
    • Faculdade de Odontologia - UERJ
    • Contact: Sergio Caetano, MSc; Phone Number: +55(21)97912-5679; Email: srocaetano@hotmail.com
    • Contact: Flavia Artese, PhD; Phone Number: +55(21)98155-4280; Email: flaviaartese@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: En Masse Retraction; Group treated by retracting the six anterior teeth simultaneously.	Procedure: 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.
Active Comparator: Two-Step Retraction; Group treated by retracting the canines incisors in two different steps.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Molar inclination	Quantitative assessment of molars inclination between the two groups as measured by tomographic superimposition at the end of space closure.	12 months
Canine inclination	Quantitative assessment of canines inclination between the two groups as measured by tomographic superimposition at the end of space closure.	12 months
Incisors inclination	Quantitative assessment of incisors inclination between the two groups as measured by tomographic superimposition at the end of space closure.	12 months

Collaborators and Investigators

• Sponsor: Rio de Janeiro State University
• Collaborators: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
• Investigators: Study Chair: Jose Augusto M Miguel, PhD, Rio de Janeiro State University; Principal Investigator: Sergio Caetano, MSc, Rio de Janeiro State University; Study Director: Flavia Artese, PhD, Rio de Janeiro State University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Bennett JC, McLaughlin RP. Controlled space closure with a preadjusted appliance system. J Clin Orthod. 1990 Apr;24(4):251-60. No abstract available.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Keim RG. Space closure and anchorage control. J Clin Orthod. 2013 Mar;47(3):153-4. No abstract available.
• Keim RG. The challenge of bimaxillary protrusion. J Clin Orthod. 2017 Jun;51(6):315-316. No abstract available.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2019
• Primary Completion (Anticipated): April 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: April 3, 2019
• First Submitted That Met QC Criteria: April 3, 2019
• First Posted (Actual): April 4, 2019

Study Record Updates

• Last Update Posted (Actual): April 5, 2019
• Last Update Submitted That Met QC Criteria: April 3, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion; Malocclusion, Angle Class I
• Other Study ID Numbers: 04186818.2.0000.5259

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No