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

Bimaxillary Protrusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03903575
• Other study ID #: 04186818.2.0000.5259
• Status: Recruiting
• Phase: N/A
• Start date: April 3, 2019
• Est. completion date: December 2020

Study information

• Verified date: April 2019
• Source: Rio de Janeiro State University
• Contact: Sergio Caetano, MSc
• Phone: +55(21)97912-5679
• Email: srocaetano[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: December 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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;

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Faculdade de Odontologia - UERJ	Rio de Janeiro

Sponsors (2)

Lead Sponsor	Collaborator
Rio de Janeiro State University	Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Country where clinical trial is conducted

Brazil, 

References & Publications (22)

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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. — View Citation

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Keim RG. The challenge of bimaxillary protrusion. J Clin Orthod. 2017 Jun;51(6):315-316. — View Citation

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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. — View Citation

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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. — View Citation

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. — View Citation

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. Review. — View Citation

Schneider PP, Gandini Júnior 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. — View Citation

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* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Molar inclination	Quantitative assessment of molars inclination between the two groups as measured by tomographic superimposition at the end of space closure.	12 months
Secondary	Canine inclination	Quantitative assessment of canines inclination between the two groups as measured by tomographic superimposition at the end of space closure.	12 months
Secondary	Incisors inclination	Quantitative assessment of incisors inclination between the two groups as measured by tomographic superimposition at the end of space closure.	12 months