NCT01770782

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

January 16, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 18, 2013

Completed
Last Updated

January 18, 2013

Status Verified

July 1, 2009

Enrollment Period

6 months

First QC Date

January 16, 2013

Last Update Submit

January 17, 2013

Conditions

Maxillary Hypoplasia

Keywords

Palatal Expansion TechniqueOrthognathic SurgeryThree Dimensional images

Outcome Measures

Primary Outcomes (1)

  • Maxillary Stability

    Laser scanner to create a 3D virtual dental cast

    up to 10 months after the end of expansion

Study Arms (2)

Laser Scanner

OTHER

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

SARME

OTHER

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)

Interventions

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.

SARME
Laser ScannerOTHER

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.

Laser Scanner

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Sao Paulo

São Paulo, São Paulo, 04020-050, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 23690355DERIVED

MeSH Terms

Conditions

Retrognathia

Condition Hierarchy (Ancestors)

Jaw AbnormalitiesJaw DiseasesMusculoskeletal DiseasesMaxillofacial AbnormalitiesCraniofacial AbnormalitiesMusculoskeletal AbnormalitiesStomatognathic DiseasesMandibular DiseasesStomatognathic System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Max D Pereira, Phd

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR

  • Gabriela PR Prado, MS

    Federal University of São Paulo

    STUDY CHAIR

  • Fabianne MG Furtado, PhD

    Federal University of São Paulo

    STUDY CHAIR

  • João PR Biló, MD

    Federal University of São Paulo

    STUDY CHAIR

  • Lydia M Ferreira, PhD

    Federal University of São Paulo

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

January 16, 2013

First Posted

January 18, 2013

Study Start

August 1, 2009

Primary Completion

February 1, 2010

Study Completion

January 1, 2011

Last Updated

January 18, 2013

Record last verified: 2009-07

Locations

BR(1)