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
|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|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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Osteotomy between the maxillary central incisors
Procedure: Osteotomy between the maxillary central incisors
Surgically Assisted Rapid Maxillary Expansion with osteotomy between the central incisors.
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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
- 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
- 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.
- Periodontal effects [ Time Frame: 2 months post-expansion. ]Assessment of periodontal changes in the teeth adjacent to the segmentation, through periodontal probing
- Surgery time [ Time Frame: During surgery ]Time elapsed during surgery.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03503448
|Contact: Pedro Andre A Pereira, DDS||55 21 email@example.com|
|Study Chair:||Fabio G Ritto, PhD||Hospital Universitario Pedro Ernesto|