Oral Health of Individuals Who Attended a Mother-child De... | NCT01272544

Studies
Oral Health of Individuals Who Attended a Mother-child Dental Care Program - Longitudinal Study

NCT01272544

Sponsor

Universidade Federal do Piauí

Status

Completed

Last Update Posted

Jan 7, 2011Estimated

Enrollment

278Actual

Phase

Not provided

Conditions

Health Behavior

Interventions

Not provided

Countries

Not provided

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

Sep 2009

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

Sep 2009

Primary Completion Date

May 2010Actual

Completion Date

May 2010Actual

First Submitted Date

Jan 6, 2011

First Submission Date that Met QC Criteria

Jan 6, 2011

First Posted Date

Jan 7, 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

Jan 6, 2011

Last Update Posted Date

Jan 7, 2011Estimated

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

The aim of this longitudinal study was to assess the oral health of individuals attending a mother-child dental care program (PPPWB). The mean DMFT and GBI in the second phase and the control group were 0.75 and 6.75, 1.47 and 10.74, respectively. It was concluded that the individuals who attended the PPPWB had better oral health status than the control group. When the two phases of the study were compared, it was noted that the individuals in the second phase had better oral health, although they had a higher score for gingival bleeding.

Detailed Description

The aim of this longitudinal study was to assess the oral health of individuals attending a mother-child dental care program (PPPWB). Letters were sent to the 343 children who were examined in phase 1. One hundred and thirty nine individuals returned for the oral examination - experimental group (40.5%). The control group consisted of 139 individuals who did not receive dental care from the PPPWB. These individuals were paired to the experimental group according to their age and socio-demographic characteristics. Gingival bleeding (GBI) and DMFT indices were used in order to determine the children's oral health status. The mean DMFT and GBI in the second phase and the control group were 0.75 and 6.75, 1.47 and 10.74, respectively. It was concluded that the individuals who attended the PPPWB had better oral health status than the control group. When the two phases of the study were compared, it was noted that the individuals in the second phase had better oral health, although they had a higher score for gingival bleeding.

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

278Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
participation in a dental health program		Group 1 - children who participated to a dental health program Group 2 - children who did not participate to dental health program
participation in a preventive program		Group 1 - children who participated to the preventive program Group 2 - children who did not participate

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children who participated to the program

Exclusion Criteria:

children who did not participate

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

9 Years

Maximum Age

13 Years

Standard Ages

Child

Study Population

Letters were sent to 343 of the examined children, inviting the guardians to take their children for an oral health assessment at the children's dental clinic at UFPI. The number of children that returned for an examination was 139, and these individuals comprised the experimental group.

Control Group After assessing the characteristics of the experimental group, the control group was determined and consisted of 139 individuals (93 females and 46 males) who were paired to the experimental group according to their socio-demographic characteristics and age but who had not attended the PPPWB.

The study hypothesis is that individuals who attended the PPPWB have better oral health than those who did not attend it.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lucia D Moura, PhD	Universidade Federal do Piaui	Study Chair
Cacilda C Lima, DDS	Universidade Federal do Piaui	Principal Investigator
Marcoeli S Moura, PhD	Universidade Federal do Piaui	Study Director
Josilda F Martins, PhD	Universidade Federal do Piaui	Study Director
Marina M Lima, PhD	Universidade Federal do Piaui	Study Director

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015438	Health Behavior
D003731	Dental Caries
D005891	Gingivitis

Ancestor Terms

ID	Term
D001519	Behavior
D017001	Tooth Demineralization
D014076	Tooth Diseases
D009057	Stomatognathic Diseases

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Browse Branches

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