NCT00066950

Brief Summary

The purpose of this study is to determine whether dental disease patterns and transmissable bacteria that are known to cause a severe form of dental decay in young children can be reduced or eliminated by treating mothers and their young infants early on with Chlorhexidine and fluoride varnish applications, respectively as part of a comprehensive Prevention Management Model.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
361

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 2003

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

March 1, 2003

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 8, 2003

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
Last Updated

March 21, 2022

Status Verified

March 1, 2022

Enrollment Period

2.3 years

First QC Date

August 7, 2003

Last Update Submit

March 7, 2022

Conditions

Dental Caries

Keywords

Early childhood caries

Outcome Measures

Primary Outcomes (1)

  • Caries Incidence and Caries Index

    Caries Incidence (number of participants who developed caries during the study) and the number of decayed or filled tooth surfaces (dfs) index.

    4 year

Study Arms (2)

Counseling Only

NO INTERVENTION

Oral Health Counseling Only

CHX+Counseling (caregiver) + FV (child)

EXPERIMENTAL

Oral Health Counseling plus Chlorhexidine for caregiver plus fluoride varnish every 6 months from 12mo to 30mo of age for child

Drug: Chlorhexidine gluconateDevice: Fluoride Varnish

Interventions

Chlorhexidine gluconateDRUG

0.5oz chlorhexidine gluconate 0.12% solution mouth rinse twice daily for 14 days then no rinse for 14 days, repeated for 3 months

Also known as: Peridex® OMNII Oral Pharmaceuticals
CHX+Counseling (caregiver) + FV (child)
Fluoride VarnishDEVICE

0.25ml FV every 6 months from age 12 to 30 months

Also known as: CavityShield® OMNII Oral Pharmaceuticals
CHX+Counseling (caregiver) + FV (child)

Eligibility Criteria

Age18 Years - 33 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Some evidence of geographic stability in South San Diego Bay Area
  • Planning on remaining in area approximately 3 years after birth of child
  • Must be able to provide consent in English or Spanish
  • Must be registered patients at San Ysidro Health Center in the prenatal program
  • Must be experiencing a normal pregnancy

You may not qualify if:

  • Diabetes, anemia, placenta previa, seizure disorders, GDM, evidence of chromosomal disorders, Polyhydramnios, Thrombophlebitis, or RH-negative status
  • Vaginal bleeding, premature uterine contractions, viral or bacterial infections, diabetes, pregnant with twins or multiple births expected
  • Previous pregnancy complications where hospitalization was required

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Ysidro Health Center

San Ysidro, California, 92173, United States

Location

Related Publications (3)

  • Ramos-Gomez F, Chung LH, Gonzalez Beristain R, Santo W, Jue B, Weintraub J, Gansky S. Recruiting and retaining pregnant women from a community health center at the US-Mexico border for the Mothers and Youth Access clinical trial. Clin Trials. 2008;5(4):336-46. doi: 10.1177/1740774508093980.

    PMID: 18697848RESULT

  • Ramos-Gomez FJ, Gansky SA, Featherstone JD, Jue B, Gonzalez-Beristain R, Santo W, Martinez E, Weintraub JA. Mother and youth access (MAYA) maternal chlorhexidine, counselling and paediatric fluoride varnish randomized clinical trial to prevent early childhood caries. Int J Paediatr Dent. 2012 May;22(3):169-79. doi: 10.1111/j.1365-263X.2011.01188.x. Epub 2011 Oct 17.

    PMID: 21999806RESULT

  • Chaffee BW, Gansky SA, Weintraub JA, Featherstone JD, Ramos-Gomez FJ. Maternal oral bacterial levels predict early childhood caries development. J Dent Res. 2014 Mar;93(3):238-44. doi: 10.1177/0022034513517713. Epub 2013 Dec 19.

    PMID: 24356441RESULT

MeSH Terms

Conditions

Dental Caries

Interventions

chlorhexidine gluconate

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Francisco J Ramos-Gomez, DDS,MS, MPH

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

  • Stuart A Gansky, DrPH

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2003

First Posted

August 8, 2003

Study Start

March 1, 2003

Primary Completion

July 1, 2005

Study Completion

August 1, 2005

Last Updated

March 21, 2022

Record last verified: 2022-03

Locations

US(1)