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Prevention of Transmission of Bacteria That Cause Cavities From Mothers to Their Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00066040
Recruitment Status : Completed
First Posted : August 5, 2003
Last Update Posted : July 17, 2012
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
walter bretz, New York University

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.

Condition or disease Intervention/treatment Phase
Caries, Dental Drug: Cervitec chlorhexidine varnish Drug: Duraphat fluoride varnish Drug: xylitol gum from Fennobon, Finland Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Prevention of Transmission of Mutans Streptococci From Mother to Child
Study Start Date : January 2001
Actual Primary Completion Date : January 2006
Actual Study Completion Date : January 2006

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00066040

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University of Pittsburgh-Univesidade de Dao Paulo
Bauru,, Sao Paulo, Brazil
Sponsors and Collaborators
New York University
National Institute of Dental and Craniofacial Research (NIDCR)
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Responsible Party: walter bretz, Assoc Prof, New York University Identifier: NCT00066040    
Obsolete Identifiers: NCT00016822
Other Study ID Numbers: NIDCR-13534
R01DE013534 ( U.S. NIH Grant/Contract )
First Posted: August 5, 2003    Key Record Dates
Last Update Posted: July 17, 2012
Last Verified: July 2012
Keywords provided by walter bretz, New York University:
mutans streptococci infections
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Chlorhexidine, thymol drug combination
Fluorides, Topical
Sodium fluoride topical preparation
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents