Comparison of 2 Techniques of Surgically Assisted Rapid Maxillary Expansion

NCT03503448 | Completed DMC

• 1 other identifier: 69696317.0.0000.5259
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Malocclusion; Maxillar Hypoplasia; Transverse Maxillary Deficiency

Keywords

surgically assisted rapid maxillary expansion; surgically assisted rapid palatal expansion; Malocclusion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Patient´s perception

  2 months post-expansion.

• Periodontal effects

  2 months post-expansion.

• Surgery time

  During surgery

Study Arms (2)

space between 11/21

OTHER

Osteotomy between the maxillary central incisors

Procedure: Osteotomy between the maxillary central incisors

space between 12/13 and 22/23

OTHER

Osteotomy between the maxillary lateral incisors and canines

Procedure: Osteotomy between the maxillary lateral incisors and canines

Interventions

Osteotomy between the maxillary central incisors PROCEDURE

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

space between 11/21

Osteotomy between the maxillary lateral incisors and canines PROCEDURE

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

space between 12/13 and 22/23

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Hospital Universitario Pedro Ernesto: lead

Study Sites (1)

Hospital Universitario Pedro Ernesto

Rio de Janeiro, 20551030, Brazil

Location

Related Publications (3)

• 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.

  PMID: 19761925 RESULT

• 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.

  PMID: 26847514 RESULT

• 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.

  PMID: 28279603 RESULT

MeSH Terms

Conditions

Malocclusion; Retrognathia

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Mandibular Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Fabio G Ritto, PhD

  Hospital Universitario Pedro Ernesto

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS, Clinical Research

Study Record Dates

• First Submitted: April 1, 2018
• First Posted: April 19, 2018
• Study Start: May 7, 2018
• Primary Completion: July 22, 2019
• Study Completion: August 5, 2019
• Last Updated: February 17, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)