Orthodontic Retention on the Maxillary Stability After SARME Using Laser Scanner

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2011-01-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Maxillary Hypoplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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).

Group Type OTHER

Laser Scanner

Intervention Type 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.

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.

Group Type OTHER

Surgically Assisted Rapid Maxillary Expansion (SARME)

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Max Domingues Pereira

MD, PhD

Responsibility Role SPONSOR_INVESTIGATOR