Skip to main content
OpenTrials
Completed

NCT Number: NCT03503448

Comparison of 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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Malocclusion Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Jaw Abnormalities Jaw Diseases Mandibular Diseases Maxillar Hypoplasia Maxillofacial Abnormalities Musculoskeletal Abnormalities Musculoskeletal Diseases Retrognathia Stomatognathic Diseases Stomatognathic System Abnormalities Tooth Diseases Transverse Maxillary Deficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Pedro Ernesto

Rio de Janeiro, 20551030, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

-

Treatment and study plan

Osteotomy between the maxillary central incisors

Procedure

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

Osteotomy between the maxillary lateral incisors and canines

Procedure

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

Primary outcomes

  1. Bone expansion and dental inclination

    Time frame: 1-2 months post-expansion.

    Assessment of bone expansion and dental inclination through Cone Beam computed tomography (CBCT) images

Secondary outcomes

  1. Patient´s perception

    Time frame: 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.

  2. Periodontal effects

    Time frame: 2 months post-expansion.

    Assessment of periodontal changes in the teeth adjacent to the segmentation, through periodontal probing

  3. Surgery time

    Time frame: During surgery

    Time elapsed during surgery.

Sponsors and collaborators

Lead sponsor

Hospital Universitario Pedro Ernesto

Other

Registry information

Official study title

Clinical Trial Comparing 2 Techniques of Surgically Assisted Rapid Maxillary Expansion

Acronym: SARME

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 19, 2018
Registry last updated
Feb 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.