Prevention of Transmission of Bacteria That Cause Cavities From Mothers to Their Children
Primary Purpose
Caries, Dental
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Cervitec chlorhexidine varnish
Duraphat fluoride varnish
xylitol gum from Fennobon, Finland
Sponsored by
About this trial
This is an interventional treatment trial for Caries, Dental focused on measuring mutans streptococci infections
Eligibility Criteria
Inclusion/Exclusion Criteria: Mother 20 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
Sites / Locations
- University of Pittsburgh-Univesidade de Dao Paulo
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00066040
First Posted
August 1, 2003
Last Updated
November 1, 2022
Sponsor
New York University
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)
1. Study Identification
Unique Protocol Identification Number
NCT00066040
Brief Title
Prevention of Transmission of Bacteria That Cause Cavities From Mothers to Their Children
Official Title
Prevention of Transmission of Mutans Streptococci From Mother to Child
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
January 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York University
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Dental decay is the most prevalent affliction in children worldwide. In recent years the occurrence of dental decay has declined dramatically in many industrialized countries subsequent to the widespread availability of fluoride in the water supply and dentifrices. However, in newly industrialized countries such as Brazil, the occurrence of decay is still high, especially among lower income groups. The mutans streptococci (MS) have been convincingly associated with human dental decay and clinical protocols, which seek to reduce the levels of MS invariably, thus resulting in a significant reduction in decay. One of the most important observations from these studies is the possibility that decay and the establishment of MS can be reduced and/or prevented in young children by treating those mothers who are highly infected with MS prior to the eruption of the primary teeth. Other studies indicate that if the MS does not colonize the primary teeth in the first year after their eruption, they are likely to remain caries free during the following years. These findings indicate that delaying the colonization of the MS in the primary dentition may prevent dental decay. The ideal population for such a study can be found in communities without water fluoridation, with a high level of unmet dental care, and who would have frequent access to sugar. Populations in many newly industrialized countries would meet these qualifications. However, it is difficult to perform an interceptive study, such as preventing the transmission of the MS from mother to infant in such countries, as the local dental community has neither the financial and physical resources nor the trained dental personnel. We have found an exception to this in the city of Bauru, Sao Paulo, Brazil. This community of 250,000 residents is situated in the sugar cane growing region of Brazil and boasts the leading dental school in South and Central America. In the investigation described, we will collaborate with the Bauru investigators in a longitudinal randomized clinical trial with the following specific aims: 1) to determine whether the salivary levels of the MS can be reduced in mothers of young infants by an intervention program consisting of restorations, topical fluorides, the use of xylitol chewing gum, chlorhexidine varnishes and oral hygiene instructions; 2) to determine whether this intervention reduces or delays the acquisition of MS in the infants and whether this in turn reduces the subsequent caries incidence in children
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caries, Dental
Keywords
mutans streptococci infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
280 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Cervitec chlorhexidine varnish
Intervention Type
Drug
Intervention Name(s)
Duraphat fluoride varnish
Intervention Type
Drug
Intervention Name(s)
xylitol gum from Fennobon, Finland
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion/Exclusion Criteria:
Mother
20 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
Facility Information:
Facility Name
University of Pittsburgh-Univesidade de Dao Paulo
City
Bauru,
State/Province
Sao Paulo
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Prevention of Transmission of Bacteria That Cause Cavities From Mothers to Their Children
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