Comparison of 2 Techniques of Surgically Assisted Rapid Maxillary Expansion (SARME)
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|ClinicalTrials.gov Identifier: NCT03503448|
Recruitment Status : Recruiting
First Posted : April 19, 2018
Last Update Posted : August 2, 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|
|Actual Study Start Date :||May 7, 2018|
|Estimated Primary Completion Date :||February 7, 2019|
|Estimated Study Completion Date :||May 7, 2019|
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
- 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.
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
|Contact: Pedro Andre A Pereira, DDS||55 21 firstname.lastname@example.org|
|Hospital Universitario Pedro Ernesto||Recruiting|
|Rio de Janeiro, Brazil, 20551030|
|Contact: Pedro Pereira, DDS 552128688266 email@example.com|
|Contact: Fabio Ritto, DDS MS Phd 552128688266 firstname.lastname@example.org|
|Study Chair:||Fabio G Ritto, PhD||Hospital Universitario Pedro Ernesto|