Clinical trial NCT01770782: Orthodontic Retention on the Maxillary Stability After SARME Using Laser Scanner
Official title: Orthodontic Retention on Dental and Skeletal Maxillary Transverse Stability After Surgically Assisted Rapid Maxillary Expansion (SARME)Using Laser Scanner
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maxillary Hypoplasia
Keywords: Palatal Expansion Technique
Orthognathic Surgery
Three Dimensional images
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2013-01-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study was to evaluate the effect of the orthodontic retainer on transverse maxillary dental and skeletal stability after SARME.

Detailed description: Methods: Ninety digitized dental casts of 30 adult patients (18 males and 12 females) submitted to SARME using the Hyrax expansion appliance were evaluated. Patients were distributed into two groups: Group Without Retention (GSC) n = 15; and Group With Retention (GCC) n = 15. In the GCC group, a Transpalatal Arch (TPA) was installed for retention soon after removal of the expander. The dental casts were scanned using a Vivid 9i 3D laser scanner (Konica Minolta, Wayne, NJ). The plaster models were performed preoperatively (T1), 4 months after the expander was removed (T2), and 10 months after the end of the expansion (T3). The distances measured were Inter-Cusps of Premolars and Molars (Inter-Cusp PM) (Inter-Cusp M), Inter-Cervicals of Premolars and Molars (Inter-Cervical PM) (Inter-Cervical M), Inter-WALA edges of Premolars and Molars (PM Inter-BW) (BW Inter-M), palatal height at the molar, and palatal area and volume at T1, T2, and T3.

Eligibility criteria: Inclusion Criteria:

* Adult patients with bilateral transverse maxillary deficiencies greater than 5 mm

Exclusion Criteria:

* Patients with previous histories of maxillary surgery,
* congenital craniofacial malformations and
* unilateral transverse maxillary deficiencies

Primary outcomes:
measure: Maxillary Stability
timeFrame: up to 10 months after the end of expansion
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Federal University of Sao Paulo
state: SP
Study officials:
affiliation: Federal University of São Paulo
name: Max D Pereira, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of São Paulo
name: Gabriela PR Prado, MS
role: STUDY_CHAIR
affiliation: Federal University of São Paulo
name: Fabianne MG Furtado, PhD
role: STUDY_CHAIR
affiliation: Federal University of São Paulo
name: João PR Biló, MD
role: STUDY_CHAIR
affiliation: Federal University of São Paulo
name: Lydia M Ferreira, PhD
role: STUDY_CHAIR
References:
citation: Prado GP, Pereira MD, Bilo JP, Furtado F, Ferreira LM. Stability of surgically assisted rapid palatal expansion: a randomized trial. J Dent Res. 2013 Jul;92(7 Suppl):49S-54S. doi: 10.1177/0022034513486899. Epub 2013 May 20.