One Year Skeletal and Dental Arch Changes Following Rapid... | NCT01765062

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

NCT01765062

Sponsor

State University of Maringá

Status

Completed

Last Update Posted

Jan 10, 2013Estimated

Enrollment

14Actual

Phase

Not provided

Conditions

Cross-bite

Interventions

Not provided

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2008

Primary Completion Date

Sep 2008Actual

Completion Date

Jul 2009Actual

First Submitted Date

Dec 20, 2012

First Submission Date that Met QC Criteria

Jan 8, 2013

First Posted Date

Jan 10, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 8, 2013

Last Update Posted Date

Jan 10, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

André Barbisan de Souza, DDS, Kelly Regina Micheletti, DDS, State University of MaringáPrincipal Investigator

Lead Sponsor

State University of MaringáOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

14Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Before Rapid Maxillary Expansion		T0
3 months After Rapid Maxillary Expansion		T1
One year After Rapid Maxillary Expansion		T2

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
changes in cephalometric variables		prior to rapid maxillary expansion (T0), after three months (T1) and after one year

Secondary Outcomes

Measure	Description	Time Frame
Dental casts		prior to rapid maxillary expansion (T0), after three months (T1) and after one year (T2).

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

cross-bite with maxillary atresia

Exclusion Criteria:

patients had undergone orthodontic treatment or had a syndrome

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

11 Years

Standard Ages

Child

Study Population

Community Sample

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Daniela G Garib, PHD	Universidade de São Paulo-USP-Faculdade de Odontologia de Bauru	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universidade Estadual de Maringa		Maringá	Paraná		Brazil

Condition Browse Module

MeSH Terms

ID	Term
D008310	Malocclusion

Ancestor Terms

ID	Term
D014076	Tooth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided