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

Primary Purpose

Malocclusion, Maxillar Hypoplasia, Transverse Maxillary Deficiency

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Osteotomy between the maxillary central incisors
Osteotomy between the maxillary lateral incisors and canines
Sponsored by
Hospital Universitario Pedro Ernesto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malocclusion focused on measuring surgically assisted rapid maxillary expansion, surgically assisted rapid palatal expansion, Malocclusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

-

Sites / Locations

  • Hospital Universitario Pedro Ernesto

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

space between 11/21

space between 12/13 and 22/23

Arm Description

Osteotomy between the maxillary central incisors

Osteotomy between the maxillary lateral incisors and canines

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Periodontal effects
Assessment of periodontal changes in the teeth adjacent to the segmentation, through periodontal probing
Surgery time
Time elapsed during surgery.

Full Information

First Posted
April 1, 2018
Last Updated
February 13, 2020
Sponsor
Hospital Universitario Pedro Ernesto
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1. Study Identification

Unique Protocol Identification Number
NCT03503448
Brief Title
Comparison of 2 Techniques of Surgically Assisted Rapid Maxillary Expansion
Acronym
SARME
Official Title
Clinical Trial Comparing 2 Techniques of Surgically Assisted Rapid Maxillary Expansion
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
May 7, 2018 (Actual)
Primary Completion Date
July 22, 2019 (Actual)
Study Completion Date
August 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario Pedro Ernesto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion, Maxillar Hypoplasia, Transverse Maxillary Deficiency
Keywords
surgically assisted rapid maxillary expansion, surgically assisted rapid palatal expansion, Malocclusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
space between 11/21
Arm Type
Other
Arm Description
Osteotomy between the maxillary central incisors
Arm Title
space between 12/13 and 22/23
Arm Type
Other
Arm Description
Osteotomy between the maxillary lateral incisors and canines
Intervention Type
Procedure
Intervention Name(s)
Osteotomy between the maxillary central incisors
Intervention Description
Surgically Assisted Rapid Maxillary Expansion with osteotomy between the central incisors.
Intervention Type
Procedure
Intervention Name(s)
Osteotomy between the maxillary lateral incisors and canines
Intervention Description
Surgically Assisted Rapid Maxillary Expansion with bilateral osteotomy between the lateral incisors and canines
Primary Outcome Measure Information:
Title
Bone expansion and dental inclination
Description
Assessment of bone expansion and dental inclination through Cone Beam computed tomography (CBCT) images
Time Frame
1-2 months post-expansion.
Secondary Outcome Measure Information:
Title
Patient´s perception
Description
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.
Time Frame
2 months post-expansion.
Title
Periodontal effects
Description
Assessment of periodontal changes in the teeth adjacent to the segmentation, through periodontal probing
Time Frame
2 months post-expansion.
Title
Surgery time
Description
Time elapsed during surgery.
Time Frame
During surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabio G Ritto, PhD
Organizational Affiliation
Hospital Universitario Pedro Ernesto
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Universitario Pedro Ernesto
City
Rio de Janeiro
ZIP/Postal Code
20551030
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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
Citations:
PubMed Identifier
19761925
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 Maxillofac Surg. 2009 Oct;67(10):2287-301. doi: 10.1016/j.joms.2009.04.069.
Results Reference
result
PubMed Identifier
26847514
Citation
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.
Results Reference
result
PubMed Identifier
28279603
Citation
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.
Results Reference
result

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Comparison of 2 Techniques of Surgically Assisted Rapid Maxillary Expansion

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