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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01765062
Other study ID # KRM-300585
Secondary ID
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


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