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CompletedNCT03503448SARMEUpdated Feb 17, 2020

Comparison of 2 Techniques of Surgically Assisted Rapid Maxillary Expansion

An interventional study of Osteotomy between the maxillary central incisors and Osteotomy between the maxillary lateral incisors and canines in Malocclusion, Maxillar Hypoplasia and Transverse Maxillary Deficiency, sponsored by Hospital Universitario Pedro Ernesto. Completed at 1 site in Brazil. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-17.

Sponsored by Hospital Universitario Pedro Ernesto · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
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Study summary

This study evaluates 2 Techniques of Surgically Assisted Rapid Maxillary Expansion (SARME) in the treatment of maxillary transverse deficiency. Half of participants will undergo an osteotomy between the maxillary central incisors, while the other half will undergo an osteotomy between the maxillary lateral incisors and canines (bilateral osteotomies).

Read the detailed description

Surgically Assisted Rapid Maxillary Expansion (SARME) can be performed by a osteotomy between the maxillary central incisors and by osteotomies between the maxillary lateral incisors and canines (bilateral).

Both techniques treat transverse maxillary hypoplasia, but they do so with different effects on esthetics, periodontium, teeth and bone expansion.

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Conditions studied

  • Malocclusion
  • Maxillar Hypoplasia
  • Transverse Maxillary Deficiency

Keywords

  • surgically assisted rapid maxillary expansion
  • surgically assisted rapid palatal expansion
  • Malocclusion
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In context

Malocclusion

323 studies on the registry are indexed under Malocclusion; 85 are open to participants now.

This study's enrollment of 20 is below the median of 37 across 242 interventional studies indexed under Malocclusion.

Browse Malocclusion studies →

Lead sponsor

Hospital Universitario Pedro Ernesto is the lead sponsor of 17 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria: patients with bilateral cross-bite and bilateral transverse maxillary deficiencies equal to or greater than 6 mm -

Exclusion Criteria: Patients with previous histories of maxillary surgery, congenital craniofacial malformations, unilateral transverse maxillary deficiencies and absence of teeth in the maxilla.

-

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Other
    space between 11/21

    Osteotomy between the maxillary central incisors

    Procedure: Osteotomy between the maxillary central incisors

  • Other
    space between 12/13 and 22/23

    Osteotomy between the maxillary lateral incisors and canines

    Procedure: Osteotomy between the maxillary lateral incisors and canines

Interventions

  • ProcedureOsteotomy between the maxillary central incisors

    Surgically Assisted Rapid Maxillary Expansion with osteotomy between the central incisors.

  • ProcedureOsteotomy between the maxillary lateral incisors and canines

    Surgically Assisted Rapid Maxillary Expansion with bilateral osteotomy between the lateral incisors and canines

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What researchers measure

Primary outcomes

  1. Bone expansion and dental inclination

    Assessment of bone expansion and dental inclination through Cone Beam computed tomography (CBCT) images

    Time frame: 1-2 months post-expansion.

Secondary outcomes

  1. Patient´s perception

    Patient´s cosmetic perception of his or her smile on a visual analogue scale (VAS) ranging from 0 to 10, where "0" represents total dissatisfaction and "10" represents total satisfaction with the postoperative smile.

    Time frame: 2 months post-expansion.

  2. Periodontal effects

    Assessment of periodontal changes in the teeth adjacent to the segmentation, through periodontal probing

    Time frame: 2 months post-expansion.

  3. Surgery time

    Time elapsed during surgery.

    Time frame: During surgery

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Study locations

1 site
  • Hospital Universitario Pedro Ernesto
    Rio de Janeiro, 20551030, Brazil
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References and documents

Publications

  • Landes CA, Laudemann K, Petruchin O, Mack MG, Kopp S, Ludwig B, Sader RA, Seitz O. Comparison of bipartite versus tripartite osteotomy for maxillary transversal expansion using 3-dimensional preoperative and postexpansion computed tomography data. J Oral Maxillofac Surg. 2009 Oct;67(10):2287-301. doi: 10.1016/j.joms.2009.04.069. PubMed 19761925 ↗
  • Betts NJ. Surgically Assisted Maxillary Expansion. Atlas Oral Maxillofac Surg Clin North Am. 2016 Mar;24(1):67-77. doi: 10.1016/j.cxom.2015.10.003. Epub 2015 Nov 24. No abstract available. PubMed 26847514 ↗
  • Camps-Pereperez I, Guijarro-Martinez R, Peiro-Guijarro MA, Hernandez-Alfaro F. The value of cone beam computed tomography imaging in surgically assisted rapid palatal expansion: a systematic review of the literature. Int J Oral Maxillofac Surg. 2017 Jul;46(7):827-838. doi: 10.1016/j.ijom.2017.01.017. Epub 2017 Mar 6. PubMed 28279603 ↗

Individual participant data

Plan to share: No — I plan to share the data on March 24, 2020 when I going to present my Master degrees' thesis. I tried to submit an article with the data. I'm waiting for a reply

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03503448
Lead sponsor
Hospital Universitario Pedro Ernesto
Responsible party
Pedro Andre Alves Pereira (DDS, Clinical Research, Hospital Universitario Pedro Ernesto) — Principal investigator
First posted
Apr 19, 2018
Start date
May 7, 2018
Primary completion
Jul 22, 2019
Completion
Aug 5, 2019
Last update
Feb 17, 2020

Study contacts

Fabio G Ritto, PhD
study chair · Hospital Universitario Pedro Ernesto

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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