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Completed

NCT Number: NCT01770782

Orthodontic Retention on the Maxillary Stability After SARME Using Laser Scanner

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

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Key information

Conditions

Maxillary Hypoplasia Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Jaw Abnormalities Jaw Diseases Mandibular Diseases Maxillofacial Abnormalities Musculoskeletal Abnormalities Musculoskeletal Diseases Retrognathia Stomatognathic Diseases Stomatognathic System Abnormalities

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of Sao Paulo

São Paulo, 04020-050, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgically Assisted Rapid Maxillary Expansion (SARME)

Procedure

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.

Laser Scanner

Other

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.

Primary outcomes

  1. Maxillary Stability

    Time frame: up to 10 months after the end of expansion

    Laser scanner to create a 3D virtual dental cast

Sponsors and collaborators

Lead sponsor

Max Domingues Pereira

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

Orthodontic Retention on Dental and Skeletal Maxillary Transverse Stability After Surgically Assisted Rapid Maxillary Expansion (SARME)Using Laser Scanner

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Jan 18, 2013
Registry last updated
Jan 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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