Orthodontic Retention on the Maxillary Stability After SARME Using Laser Scanner

This study has been completed.
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Max Domingues Pereira, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01770782
First received: January 16, 2013
Last updated: January 17, 2013
Last verified: July 2009
  Purpose

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


Condition Intervention
Maxillary Hypoplasia
Procedure: Surgically Assisted Rapid Maxillary Expansion (SARME)
Other: Laser Scanner

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Orthodontic Retention on Dental and Skeletal Maxillary Transverse Stability After Surgically Assisted Rapid Maxillary Expansion (SARME)Using Laser Scanner

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Maxillary Stability [ Time Frame: up to 10 months after the end of expansion ] [ Designated as safety issue: Yes ]
    Laser scanner to create a 3D virtual dental cast


Enrollment: 30
Study Start Date: August 2009
Study Completion Date: January 2011
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Laser Scanner
Laser Scanner (Vivid 9i® - Konica Minolta)was used to digitize the study casts. After scanning the dental casts a 3D virtual dental casts was used to realize all measurements (pre-treatment, 4 months and 10 months).
Other: Laser Scanner
Laser Scanner Vivid 9i was used to digitize the study models. The 3d virtual dental casts is a reliable copy of the original dental casts. On this virtual casts all measurements (linear, area and volume of the palate) was done to evaluate the stability after SARME.
SARME
Surgically Assisted rapid Maxillary Expansion -SARME was used for the treatment of transverse maxillary deficiency.This procedure is a combination of a surgical procedure and orthopedic expansion of the maxilla.
Procedure: Surgically Assisted Rapid Maxillary Expansion (SARME)
Surgical technique is performed with subtotal LeFort I osteotomy with separation of the pterygomaxillary fissure.The procedure was performed under general anesthesia using endotracheal intubation. Following the osteotomies, the expander screw was activated to 1.6 mm intraoperatively until a small diastema was observed between the upper central incisors. The incision was sutured along two planes.

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

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01770782

Locations
Brazil
Federal University of Sao Paulo
Sao Paulo, SP, Brazil, 04020-050
Sponsors and Collaborators
Max Domingues Pereira
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Max D Pereira, Phd Federal University of São Paulo
Study Chair: Gabriela PR Prado, MS Federal University of São Paulo
Study Chair: Fabianne MG Furtado, PhD Federal University of Sao Paulo
Study Chair: João PR Biló, MD Federal University of Sao Paulo
Study Chair: Lydia M Ferreira, PhD Federal University of Sao Paulo
  More Information

No publications provided by Federal University of São Paulo

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Max Domingues Pereira, MD, PhD, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01770782     History of Changes
Other Study ID Numbers: 0949/09
Study First Received: January 16, 2013
Last Updated: January 17, 2013
Health Authority: Brazil: Associação Fundo de Incentivo à Pesquisa
Brazil: Ethics Committee
Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of São Paulo:
Palatal Expansion Technique
Orthognathic Surgery
Three Dimensional images

Additional relevant MeSH terms:
Micrognathism
Jaw Abnormalities
Jaw Diseases
Musculoskeletal Diseases
Maxillofacial Abnormalities
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Stomatognathic Diseases
Stomatognathic System Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on September 29, 2014