NCT01765062

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2008

Shorter than P25 for all trials

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

July 1, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2012

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 10, 2013

Completed
Last Updated

January 10, 2013

Status Verified

January 1, 2013

Enrollment Period

2 months

First QC Date

December 20, 2012

Last Update Submit

January 8, 2013

Conditions

Cross-bite

Keywords

Rapid maxillary expansionCross biteHaas applianceLateral cephalograms

Outcome Measures

Primary Outcomes (1)

  • changes in cephalometric variables

    prior to rapid maxillary expansion (T0), after three months (T1) and after one year

Secondary Outcomes (1)

  • Dental casts

    prior to rapid maxillary expansion (T0), after three months (T1) and after one year (T2).

Study Arms (3)

Before Rapid Maxillary Expansion

T0

3 months After Rapid Maxillary Expansion

T1

One year After Rapid Maxillary Expansion

T2

Eligibility Criteria

Age5 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Community Sample

You may qualify if:

  • cross-bite with maxillary atresia

You may not qualify if:

  • patients had undergone orthodontic treatment or had a syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Estadual de Maringa

Maringá, Paraná, Brazil

Location

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • Daniela G Garib, PHD

    Universidade de São Paulo-USP-Faculdade de Odontologia de Bauru

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Kelly Regina Micheletti, DDS

Study Record Dates

First Submitted

December 20, 2012

First Posted

January 10, 2013

Study Start

July 1, 2008

Primary Completion

September 1, 2008

Study Completion

July 1, 2009

Last Updated

January 10, 2013

Record last verified: 2013-01

Locations

BR(1)