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

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ClinicalTrials.gov Identifier: NCT03503448
Recruitment Status : Not yet recruiting
First Posted : April 19, 2018
Last Update Posted : April 19, 2018
Sponsor:
Information provided by (Responsible Party):
Pedro Andre Alves Pereira, 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).

Condition or disease Intervention/treatment Phase
Malocclusion Maxillar Hypoplasia Maxilla Procedure: Osteotomy between the maxillary central incisors Procedure: Osteotomy between the maxillary lateral incisors and canines Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Trial Comparing 2 Techniques of Surgically Assisted Rapid Maxillary Expansion
Estimated Study Start Date : May 7, 2018
Estimated Primary Completion Date : February 7, 2019
Estimated Study Completion Date : May 7, 2019

Arm Intervention/treatment
space between 11/21
Osteotomy between the maxillary central incisors
Procedure: Osteotomy between the maxillary central incisors
Surgically Assisted Rapid Maxillary Expansion with osteotomy between the central incisors.

space between 12/13 and 22/23
Osteotomy between the maxillary lateral incisors and canines
Procedure: Osteotomy between the maxillary lateral incisors and canines
Surgically Assisted Rapid Maxillary Expansion with bilateral osteotomy between the lateral incisors and canines




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03503448


Contacts
Contact: Pedro Andre A Pereira, DDS 55 21 2868-8282 pedrofacial@gmail.com

Sponsors and Collaborators
Hospital Universitario Pedro Ernesto
Investigators
Study Chair: Fabio G Ritto, PhD Hospital Universitario Pedro Ernesto

Publications of Results:
Responsible Party: Pedro Andre Alves Pereira, DDS, Clinical Research, Hospital Universitario Pedro Ernesto
ClinicalTrials.gov Identifier: NCT03503448     History of Changes
Other Study ID Numbers: 69696317.0.0000.5259
First Posted: April 19, 2018    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pedro Andre Alves Pereira, Hospital Universitario Pedro Ernesto:
surgically assisted rapid maxillary expansion
surgically assisted rapid palatal expansion
Malocclusion

Additional relevant MeSH terms:
Malocclusion
Tooth Diseases
Stomatognathic Diseases