Comparison of 2 Techniques of Surgically Assisted Rapid Maxillary Expansion

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Trial Comparing 2 Techniques of Surgically Assisted Rapid Maxillary Expansion

Conditions
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Malocclusion, Maxillar Hypoplasia, Transverse Maxillary Deficiency

Intervention / Treatment
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* Procedure: Osteotomy between the maxillary central incisors
* Procedure: Osteotomy between the maxillary lateral incisors and canines


Participation Criteria
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Eligibility Criteria
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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. -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: space between 11/21<br>Osteotomy between the maxillary central incisors | Procedure: Osteotomy between the maxillary central incisors<br>* Surgically Assisted Rapid Maxillary Expansion with osteotomy between the central incisors.<br>|
| Other: space between 12/13 and 22/23<br>Osteotomy between the maxillary lateral incisors and canines | Procedure: Osteotomy between the maxillary lateral incisors and canines<br>* Surgically Assisted Rapid Maxillary Expansion with bilateral osteotomy between the lateral incisors and canines<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone expansion and dental inclination | Assessment of bone expansion and dental inclination through Cone Beam computed tomography (CBCT) images | 1-2 months post-expansion. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 months post-expansion. | 
| Periodontal effects | Assessment of periodontal changes in the teeth adjacent to the segmentation, through periodontal probing | 2 months post-expansion. | 
| Surgery time | Time elapsed during surgery. | During surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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surgically assisted rapid maxillary expansion, surgically assisted rapid palatal expansion, Malocclusion