NCT00066040

Brief Summary

The purpose of this study is to control the levels of bacteria that causes cavities in mothers by a combination of treatments that include fluoride and chlorhexidine varnishes and xylitol-chewing gum before the appearance of teeth in the mouth of their children. By doing that we expect to reduce the acquisition of the bacteria that causes cavities (the mutans streptococci) by the children which in turn will reduce the development of cavities.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
280

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2001

Longer than P75 for not_applicable

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

January 1, 2001

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

August 1, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2003

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
Last Updated

November 3, 2022

Status Verified

July 1, 2012

Enrollment Period

5 years

First QC Date

August 1, 2003

Last Update Submit

November 1, 2022

Conditions

Caries, Dental

Keywords

mutans streptococci infections

Interventions

Cervitec chlorhexidine varnishDRUG
Duraphat fluoride varnishDRUG
xylitol gum from Fennobon, FinlandDRUG

Eligibility Criteria

Age2 Months - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may not qualify if:

  • Mother
  • teeth
  • Medically healthy
  • First-time mother
  • High levels of the mutans streptococci
  • No fluoride exposure in the previous 6 months.
  • Infant
  • Medically healthy
  • No cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh-Univesidade de Dao Paulo

Bauru, São Paulo, Brazil

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2003

First Posted

August 5, 2003

Study Start

January 1, 2001

Primary Completion

January 1, 2006

Study Completion

January 1, 2006

Last Updated

November 3, 2022

Record last verified: 2012-07

Locations

BR(1)