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Orthodontic Retention on the Maxillary Stability After SARME Using Laser Scanner

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ClinicalTrials.gov Identifier: NCT01770782
Recruitment Status : Completed
First Posted : January 18, 2013
Last Update Posted : January 18, 2013
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

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.

Condition or disease Intervention/treatment Phase
Maxillary Hypoplasia Procedure: Surgically Assisted Rapid Maxillary Expansion (SARME) Other: Laser Scanner Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : August 2009
Actual Primary Completion Date : February 2010
Actual Study Completion Date : January 2011

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Maxillary Stability [ Time Frame: up to 10 months after the end of expansion ]
    Laser scanner to create a 3D virtual dental cast



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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): 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

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
First Posted: January 18, 2013    Key Record Dates
Last Update Posted: January 18, 2013
Last Verified: July 2009

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