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

Primary Purpose

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

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
En masse anterior teeth retraction
Two-Step Retraction
Sponsored by
Rio de Janeiro State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malocclusion, Angle Class I

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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;

Sites / Locations

  • Faculdade de Odontologia - UERJRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

En Masse Retraction

Two-Step Retraction

Arm Description

Group treated by retracting the six anterior teeth simultaneously.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 3, 2019
Last Updated
April 3, 2019
Sponsor
Rio de Janeiro State University
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
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1. Study Identification

Unique Protocol Identification Number
NCT03903575
Brief Title
3D Comparison of Anterior Teeth Retraction and Anchorage Control Between En-masse and Two-step Mechanics
Official Title
3D Comparison of Anterior Teeth Retraction and Anchorage Control Between En-masse and Two-step Mechanics: A Randomized Prospective Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 3, 2019 (Actual)
Primary Completion Date
April 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rio de Janeiro State University
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion, Angle Class I, Bimaxillary Protrusion, Orthodontic Space Closure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
En Masse Retraction
Arm Type
Experimental
Arm Description
Group treated by retracting the six anterior teeth simultaneously.
Arm Title
Two-Step Retraction
Arm Type
Active Comparator
Arm Description
Group treated by retracting the canines incisors in two different steps.
Intervention Type
Procedure
Intervention Name(s)
En masse anterior teeth retraction
Intervention Description
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
Intervention Name(s)
Two-Step Retraction
Intervention Description
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.
Primary Outcome Measure Information:
Title
Anchorage loss
Description
Quantitative assessment of posterior anchorage loss between the two groups as measured by tomographic superimposition at the end of space closure.
Time Frame
12 months
Title
Anterior teeth retraction
Description
Quantitative assessment of anterior teeth retraction between the two groups as measured by tomographic superimposition at the end of space closure.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Molar inclination
Description
Quantitative assessment of molars inclination between the two groups as measured by tomographic superimposition at the end of space closure.
Time Frame
12 months
Title
Canine inclination
Description
Quantitative assessment of canines inclination between the two groups as measured by tomographic superimposition at the end of space closure.
Time Frame
12 months
Title
Incisors inclination
Description
Quantitative assessment of incisors inclination between the two groups as measured by tomographic superimposition at the end of space closure.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sergio Caetano, MSc
Phone
+55(21)97912-5679
Email
srocaetano@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Flavia Artese, PhD
Phone
+55(21)98155-4280
Email
flaviaartese@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sergio Caetano, MSc
Organizational Affiliation
Rio de Janeiro State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Flavia Artese, PhD
Organizational Affiliation
Rio de Janeiro State University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jose Augusto M Miguel, PhD
Organizational Affiliation
Rio de Janeiro State University
Official's Role
Study Chair
Facility Information:
Facility Name
Faculdade de Odontologia - UERJ
City
Rio de Janeiro
ZIP/Postal Code
20551-030
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sergio Caetano, MSc
Phone
+55(21)97912-5679
Email
srocaetano@hotmail.com
First Name & Middle Initial & Last Name & Degree
Flavia Artese, PhD
Phone
+55(21)98155-4280
Email
flaviaartese@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
18004930
Citation
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.
Results Reference
background
PubMed Identifier
21055588
Citation
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.
Results Reference
background
PubMed Identifier
30475647
Citation
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.
Results Reference
background
PubMed Identifier
19852663
Citation
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.
Results Reference
background
PubMed Identifier
15877034
Citation
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.
Results Reference
background
PubMed Identifier
2094736
Citation
Bennett JC, McLaughlin RP. Controlled space closure with a preadjusted appliance system. J Clin Orthod. 1990 Apr;24(4):251-60. No abstract available.
Results Reference
background
PubMed Identifier
27275623
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.
Results Reference
background
PubMed Identifier
30573856
Citation
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.
Results Reference
background
PubMed Identifier
29302879
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.
Results Reference
background
PubMed Identifier
16227481
Citation
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.
Results Reference
background
PubMed Identifier
16679201
Citation
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.
Results Reference
background
PubMed Identifier
16637733
Citation
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.
Results Reference
background
PubMed Identifier
14719740
Citation
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.
Results Reference
background
PubMed Identifier
30697398
Citation
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.
Results Reference
background
PubMed Identifier
23660788
Citation
Keim RG. Space closure and anchorage control. J Clin Orthod. 2013 Mar;47(3):153-4. No abstract available.
Results Reference
background
PubMed Identifier
29059058
Citation
Keim RG. The challenge of bimaxillary protrusion. J Clin Orthod. 2017 Jun;51(6):315-316. No abstract available.
Results Reference
background
PubMed Identifier
19852656
Citation
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.
Results Reference
background
PubMed Identifier
10715095
Citation
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.
Results Reference
background
PubMed Identifier
11302594
Citation
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.
Results Reference
background
PubMed Identifier
23910203
Citation
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.
Results Reference
background
PubMed Identifier
1062936
Citation
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.
Results Reference
background
PubMed Identifier
11668872
Citation
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.
Results Reference
background

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

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