Malocclusion, Angle Class INCT03903575
3D Comparison of Anterior Teeth Retraction and Anchorage Control Between En-masse and Two-step Mechanics
A study testing En masse anterior teeth retraction and Two-Step Retraction in people with Malocclusion, Angle Class I and Bimaxillary Protrusion, run by Rio de Janeiro State University at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Malocclusion, Angle Class I, Bimaxillary Protrusion, Orthodontic Space Closure
- What is being tested?
- En masse anterior teeth retraction and Two-Step Retraction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteBrazil
- Study dates
- 3 Apr 2019to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Faculdade de Odontologia - UERJ
Rio de Janeiro, 20551-030
Sergio Caetano, MSc, +55(21)97912-5679, srocaetano@hotmail.com
Flavia Artese, PhD, +55(21)98155-4280, flaviaartese@gmail.com
About this study
Official title: 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.
- Being tested
- En masse anterior teeth retraction, Two-Step Retraction
- Medical subject headings
- Malocclusion, Angle Class I
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
En masse anterior teeth retractionProcedure or surgery
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 RetractionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| En Masse Retraction | Experimental | Group treated by retracting the six anterior teeth simultaneously. Receives: Procedure: En masse anterior teeth retraction |
| Two-Step Retraction | Active comparator | Group treated by retracting the canines incisors in two different steps. Receives: Procedure: Two-Step Retraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anchorage loss
Quantitative assessment of posterior anchorage loss between the two groups as measured by tomographic superimposition at the end of space closure.
Measured: 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.
Measured: 12 months
Secondary outcomes (3)
Molar inclination
Quantitative assessment of molars inclination between the two groups as measured by tomographic superimposition at the end of space closure.
Measured: 12 months
Canine inclination
Quantitative assessment of canines inclination between the two groups as measured by tomographic superimposition at the end of space closure.
Measured: 12 months
Incisors inclination
Quantitative assessment of incisors inclination between the two groups as measured by tomographic superimposition at the end of space closure.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start3 Apr 2019
- Primary completionApr 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Malocclusion, Angle Class IStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rio de Janeiro State University
- Sponsor type
- University, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Responsible party
- Principal investigator, Sergio Roberto de Oliveira Caetano, Rio de Janeiro State University
- Investigators
- Sergio Caetano, MSc, Principal investigator, Rio de Janeiro State UniversityFlavia Artese, PhD, Study director, Rio de Janeiro State UniversityJose Augusto M Miguel, PhD, Study chair, Rio de Janeiro State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03903575
- Sponsor's protocol ID
- 04186818.2.0000.5259
- Status last verified
- Apr 2019
- First submitted
- 3 Apr 2019
- Last updated
- 5 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 18004930Xu 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.
PubMed 21055588Schneider 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.
PubMed 30475647Leonardi 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.
PubMed 19852663Kojima 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.
PubMed 15877034Bennett JC, McLaughlin RP. Controlled space closure with a preadjusted appliance system. J Clin Orthod. 1990 Apr;24(4):251-60. No abstract available.
PubMed 2094736Ribeiro 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.
PubMed 27275623Pervin 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.
PubMed 30573856Rizk 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.
PubMed 29302879Cevidanes 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.
PubMed 16227481Cevidanes 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.
PubMed 16679201Feldmann 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.
PubMed 16637733Geron 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.
PubMed 14719740Domingo-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.
PubMed 30697398Keim RG. Space closure and anchorage control. J Clin Orthod. 2013 Mar;47(3):153-4. No abstract available.
PubMed 23660788
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D Comparison of Anterior Teeth Retraction and Anchorage Control Between En-masse and Two-step Mechanics: A Randomized Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT03903575
- Acronym / sponsor ID
- 04186818.2.0000.5259
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Rio de Janeiro State UniversityUniversity, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- 3 Apr 2019 (actual)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 4 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| En Masse Retraction | Experimental | Procedure: En masse anterior teeth retractionGroup treated by retracting the six anterior teeth simultaneously. |
| Two-Step Retraction | Active comparator | Procedure: Two-Step RetractionGroup treated by retracting the canines incisors in two different steps. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (4 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| En masse anterior teeth retractionAfter extraction of the four premolars the posterior teeth will be tied-together and the six anterior teeth will be retracted by sliding mechanics. | Procedure or surgery | En Masse Retraction |
| Two-Step RetractionAfter 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. | Procedure or surgery | Two-Step Retraction |
Primary outcome
Anchorage loss
Time frame: 12 months
Quantitative assessment of posterior anchorage loss between the two groups as measured by tomographic superimposition at the end of space closure.
Anterior teeth retraction
Time frame: 12 months
Quantitative assessment of anterior teeth retraction between the two groups as measured by tomographic superimposition at the end of space closure.
3 secondary outcomes
Molar inclination
Time frame: 12 months
Canine inclination
Time frame: 12 months
Incisors inclination
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2019.
- Background: PubMed 18004930Heo 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.
- Background: PubMed 21055588Xu 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.
- Background: PubMed 30475647Schneider 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.
- Background: PubMed 19852663Leonardi 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.
- Background: PubMed 15877034Kojima 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.
- Background: PubMed 2094736Bennett JC, McLaughlin RP. Controlled space closure with a preadjusted appliance system. J Clin Orthod. 1990 Apr;24(4):251-60. No abstract available.
- Background: PubMed 27275623Ribeiro 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.
- Background: PubMed 30573856Pervin 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.
- Background: PubMed 29302879Rizk 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.
- Background: PubMed 16227481Cevidanes 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.
- Background: PubMed 16679201Cevidanes 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.
- Background: PubMed 16637733Feldmann 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sergio Caetano, MSc principal investigator
Rio de Janeiro State University
Flavia Artese, PhD study director
Rio de Janeiro State University
Jose Augusto M Miguel, PhD study chair
Rio de Janeiro State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing En masse anterior teeth retraction and Two-Step Retraction in people with Malocclusion, Angle Class I and Bimaxillary Protrusion, run by Rio de Janeiro State University at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sergio Caetano, MSc (+55(21)97912-5679, srocaetano@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anchorage loss (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03903575, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2019.