SARME: Comparison of 2 Techniques of Surgically Assisted Rapid Maxillary Expansion

• Sponsor: Hospital Universitario Pedro Ernesto (Other)
• Overall Status: Completed
• CT.gov ID: NCT03503448
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Actual Duration (Months): 14.9
• Patients Per Site Per Month: 1.3

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Malocclusion; Maxillar Hypoplasia; Transverse Maxillary Deficiency	Procedure: Osteotomy between the maxillary central incisors; Procedure: Osteotomy between the maxillary lateral incisors and canines	N/A

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 Design

• Study Type: Interventional
• Actual 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
• Actual Study Start Date: May 7, 2018
• Actual Primary Completion Date: Jul 22, 2019
• Actual Study Completion Date: Aug 5, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.
Other: 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

Outcome Measures

Primary Outcome Measures

1. Bone expansion and dental inclination [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 [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 [2 months post-expansion.]

   Assessment of periodontal changes in the teeth adjacent to the segmentation, through periodontal probing

3. Surgery time [During surgery]

   Time elapsed during surgery.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

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Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Universitario Pedro Ernesto	Rio de Janeiro		Brazil	20551030

Sponsors and Collaborators

• Hospital Universitario Pedro Ernesto

Investigators

• Study Chair: Fabio G Ritto, PhD, Hospital Universitario Pedro Ernesto

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pedro Andre Alves Pereira, DDS, Clinical Research, Hospital Universitario Pedro Ernesto
• ClinicalTrials.gov Identifier: NCT03503448
• Other Study ID Numbers: 69696317.0.0000.5259
• First Posted: Apr 19, 2018
• Last Update Posted: Feb 17, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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, DDS, Clinical Research, Hospital Universitario Pedro Ernesto: surgically assisted rapid maxillary expansion; surgically assisted rapid palatal expansion; Malocclusion
• Additional relevant MeSH terms: Malocclusion

Study Results

No Results Posted as of Feb 17, 2020