Lips and Tongue of Mouth Breathing Children | NCT01296828

Studies
Lips and Tongue of Mouth Breathing Children

NCT01296828

Sponsor

Pontificia Universidade Catolica de Sao Paulo

Status

Unknown status

Last Update Posted

Feb 16, 2011Estimated

Enrollment

40Actual

Phase

Not provided

Conditions

Mouth Breathing

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

Nov 2010Actual

Completion Date

May 2011Estimated

First Submitted Date

Feb 1, 2011

First Submission Date that Met QC Criteria

Feb 15, 2011

First Posted Date

Feb 16, 2011Estimated

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

Feb 15, 2011

Last Update Posted Date

Feb 16, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Pontificia Universidade Catolica de Sao PauloOTHER

Collaborators

Name	Class
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Purpose: to characterize the posture, tone and mobility of lips and tongue of mouth breathing children.

Methods: 40 mouth breathing children, 26 (65%) male and 14 (35%) female, aging between 7 and 10 years old, were involved in this research realized in São Paulo, SP, Brazil . It was used the MBGR protocol to evaluate the posture, tone and mobility of lips and tongue of mouth breathing children.

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

Not provided

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

40Actual

Label	Type	Description	Intervention Names
MOUTH BREATHING CHILDREN

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Mouth breathing children diagnosed by doctor.

Exclusion Criteria:

Children with mental, neurological or hearing diseases, or with cold or flu at the examination day.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Years

Maximum Age

10 Years

Standard Ages

Child

Study Population

40 mouth breathing children, 26 (65%) male and 14 (35%) female, aging between 7 and 10 years old, were involved in this research realized in Instituto CEFAC, São Paulo, SP, Brazil.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Irene Q Marchesan	CEFAC Educação e Saúde	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Instituto CEFAC		São Paulo	São Paulo		Brazil

Type	Date	Date Unknown
Release	May 5, 2015
Reset	May 21, 2015
Release	Apr 10, 2019
Reset	Jul 1, 2019

Submission Tracking

Estimated Results First Submitted Date

May 5, 2015

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
May 5, 2015			May 21, 2015
Apr 10, 2019

Condition Browse Module

MeSH Terms

ID	Term
D009058	Mouth Breathing

Ancestor Terms

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided