Clinical trial NCT03503448: Comparison of 2 Techniques of Surgically Assisted Rapid Maxillary Expansion
Official title: Clinical Trial Comparing 2 Techniques of Surgically Assisted Rapid Maxillary Expansion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malocclusion
Maxillar Hypoplasia
Transverse Maxillary Deficiency
Keywords: surgically assisted rapid maxillary expansion
surgically assisted rapid palatal expansion
Malocclusion
Lead sponsor: Hospital Universitario Pedro Ernesto
Sponsor class: OTHER
First posted: 2018-04-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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.

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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Primary outcomes:
measure: Bone expansion and dental inclination
timeFrame: 1-2 months post-expansion.
Secondary outcomes:
measure: Patient´s perception
timeFrame: 2 months post-expansion.
measure: Periodontal effects
timeFrame: 2 months post-expansion.
measure: Surgery time
timeFrame: During surgery
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Hospital Universitario Pedro Ernesto
Study officials:
affiliation: Hospital Universitario Pedro Ernesto
name: Fabio G Ritto, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.