Comparison of 2 Techniques of Surgically Assisted Rapid Maxillary Expansion

Malocclusion Clinical Trial

— SARME  

Official title:

Clinical Trial Comparing 2 Techniques of Surgically Assisted Rapid Maxillary Expansion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03503448
• Other study ID #: 69696317.0.0000.5259
• Status: Completed
• Phase: N/A
• Start date: May 7, 2018
• Est. completion date: August 5, 2019

Study information

• Verified date: February 2020
• Source: Hospital Universitario Pedro Ernesto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 5, 2019
• Est. primary completion date: July 22, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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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Related Conditions & MeSH terms

• Malocclusion
• Maxillar Hypoplasia
• Transverse Maxillary Deficiency

Intervention

Procedure:
• Osteotomy between the maxillary central incisors
Surgically Assisted Rapid Maxillary Expansion with osteotomy between the central incisors.
• Osteotomy between the maxillary lateral incisors and canines
Surgically Assisted Rapid Maxillary Expansion with bilateral osteotomy between the lateral incisors and canines

Locations

Country	Name	City	State
Brazil	Hospital Universitario Pedro Ernesto	Rio de Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Pedro Ernesto

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

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. Review. — View Citation

Camps-Perepérez I, Guijarro-Martínez R, Peiró-Guijarro MA, Hernández-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;4 — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	Periodontal effects	Assessment of periodontal changes in the teeth adjacent to the segmentation, through periodontal probing	2 months post-expansion.
Secondary	Surgery time	Time elapsed during surgery.	During surgery