A Pilot Study to Promote Maternal and Infant Oral Health | NCT00719238

Studies
A Pilot Study to Promote Maternal and Infant Oral Health

NCT00719238

Sponsor

UConn Health

Status

Completed

Last Update Posted

Jul 21, 2008Estimated

Enrollment

121Actual

Phase

Not Applicable

Conditions

Dental Caries

Interventions

Nutrition plus education
Education only

Countries

United States

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

ID	Type	Description	Link
CTF2007

Status Module

Record Verification Date

Jul 2008

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

Jan 2007

Primary Completion Date

May 2008Actual

Completion Date

Jul 2008Actual

First Submitted Date

Jul 17, 2008

First Submission Date that Met QC Criteria

Jul 18, 2008

First Posted Date

Jul 21, 2008Estimated

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

Jul 18, 2008

Last Update Posted Date

Jul 21, 2008Estimated

Name	Class
Connecticut Health Foundation	OTHER

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 long term goals of this project are to develop and implement a combined prenatal and postnatal intervention to decrease early childhood caries. The program is based on risk assessment, diet intervention and counseling. To accomplish these goals a pilot study is needed to determine: 1) The ability to recruit and retain pregnant mothers in an intervention program; 2) The levels of S. mutans in pregnant mothers; 3) The ability of a diet intervention to decrease S. mutans in pregnant mothers.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

121Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Behavioral: Nutrition plus education
2	Active Comparator		Behavioral: Education only

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nutrition plus education	Behavioral	Nutritional instruction in small groups plus education	1

Measure	Description	Time Frame
Sugar intake		3 months post partum

Measure	Description	Time Frame
mutans streptococci levels		3 months post partum

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18 or over;
Pregnant
High S. mutans levels

Exclusion Criteria:

Younger than 18;
Other health conditions

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Susan Reisine, PhD	UConn Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Connecticut Health Center		Farmington	Connecticut	06030	United States

Condition Browse Module

MeSH Terms

ID	Term
D003731	Dental Caries

Ancestor Terms

ID	Term
D017001	Tooth Demineralization
D014076	Tooth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009752	Nutritional Status
D004522	Educational Status

Ancestor Terms

ID	Term
D009747	Nutritional Physiological Phenomena
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena
D006304	Health Status

Browse Leaves

Not provided

Browse Branches

Not provided