Comparison of 2 Techniques of Surgically Assisted Rapid Maxillary Expansion (SARME)

Clinical Trial Comparing 2 Techniques of Surgically Assisted Rapid Maxillary Expansion

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).

Study Overview

• Status: Completed
• Conditions: Malocclusion; Transverse Maxillary Deficiency; Maxillar Hypoplasia
• Intervention / Treatment: Procedure: Osteotomy between the maxillary central incisors; Procedure: Osteotomy between the maxillary lateral incisors and canines

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio de Janeiro, Brazil, 20551030
    • Hospital Universitário Pedro Ernesto

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: space between 11/21; Osteotomy between the maxillary central incisors	Procedure: Osteotomy between the maxillary central incisors; Surgically Assisted Rapid Maxillary Expansion with osteotomy between the 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; Surgically Assisted Rapid Maxillary Expansion with bilateral osteotomy between the lateral incisors and canines

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone expansion and dental inclination	Assessment of bone expansion and dental inclination through Cone Beam computed tomography (CBCT) images	1-2 months post-expansion.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 months post-expansion.
Periodontal effects	Assessment of periodontal changes in the teeth adjacent to the segmentation, through periodontal probing	2 months post-expansion.
Surgery time	Time elapsed during surgery.	During surgery

Collaborators and Investigators

• Sponsor: Hospital Universitario Pedro Ernesto
• Investigators: Study Chair: Fabio G Ritto, PhD, Hospital Universitário Pedro Ernesto

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2018
• Primary Completion (Actual): July 22, 2019
• Study Completion (Actual): August 5, 2019

Study Registration Dates

• First Submitted: April 1, 2018
• First Submitted That Met QC Criteria: April 11, 2018
• First Posted (Actual): April 19, 2018

Study Record Updates

• Last Update Posted (Actual): February 17, 2020
• Last Update Submitted That Met QC Criteria: February 13, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: surgically assisted rapid maxillary expansion; Malocclusion; surgically assisted rapid palatal expansion
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion
• Other Study ID Numbers: 69696317.0.0000.5259

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No