Comparison of 2 Techniques of Surgically Assisted Rapid Maxillary Expansion

Not Applicable

Completed

• Conditions: Malocclusion; Maxillar Hypoplasia; Transverse Maxillary Deficiency
• Interventions: Procedure: Osteotomy between the maxillary central incisors; Procedure: Osteotomy between the maxillary lateral incisors and canines

• Registration Number: NCT03503448
• Lead Sponsor: Hospital Universitario Pedro Ernesto

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.

Study Timeline

• Study First Submitted: 2018-04-01
• Study First Submitted QC: 2018-04-11
• Study First Posted: 2018-04-19
• Study Start: 2018-05-07
• Primary Completion: 2019-07-22
• Study Completion: 2019-08-05
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-13
• Last Update Posted: 2020-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
space between 11/21	Osteotomy between the maxillary central incisors	Osteotomy between the maxillary central incisors
space between 12/13 and 22/23	Osteotomy between the maxillary lateral incisors and canines	Osteotomy between the maxillary lateral incisors and canines

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Patient´s perception	2 months post-expansion.	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.
Surgery time	During surgery	Time elapsed during surgery.
Periodontal effects	2 months post-expansion.	Assessment of periodontal changes in the teeth adjacent to the segmentation, through periodontal probing

Trial Locations

Locations (1)

Hospital Universitario Pedro Ernesto; 🇧🇷 Rio de Janeiro, Brazil