One Year Skeletal and Dental Arch Changes Following Rapid Maxillary Expansion Treatment in Children

Cross-bite Clinical Trial

— ERM  

Official title:

One Year Skeletal and Dental Arch Changes Following Rapid Maxillary Expansion Treatment in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01765062
• Other study ID #: KRM-300585
• Status: Completed
• Phase: N/A
• First received: December 20, 2012
• Last updated: January 8, 2013
• Start date: July 2008
• Est. completion date: July 2009

Study information

• Verified date: January 2013
• Source: State University of Maringá
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Sistema NAcional de Ética em Pesquisa (SISNEP)
• Study type: Observational

Clinical Trial Summary

Many author have exposed the rapid and slow expansion, the diversity of activation and containment protocols and the follow-up time, justify the need for more studies to evaluate the effects to the ERM for the long-term.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: July 2009
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 11 Years

Eligibility

Inclusion Criteria:

• cross-bite with maxillary atresia

Exclusion Criteria:

• patients had undergone orthodontic treatment or had a syndrome

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cross-bite

Locations

Country	Name	City	State
Brazil	Universidade Estadual de Maringa	Maringa	Parana

Sponsors (1)

Lead Sponsor	Collaborator
State University of Maringá

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in cephalometric variables		prior to rapid maxillary expansion (T0), after three months (T1) and after one year	Yes
Secondary	Dental casts		prior to rapid maxillary expansion (T0), after three months (T1) and after one year (T2).	Yes