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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.
ClinicalTrials.gov Identifier: NCT00066040
Recruitment Status : Completed
First Posted : August 5, 2003
Last Update Posted : July 17, 2012
Information provided by (Responsible Party):

August 1, 2003
August 5, 2003
July 17, 2012
January 2001
January 2006   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00066040 on ClinicalTrials.gov Archive Site
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Prevention of Transmission of Bacteria That Cause Cavities From Mothers to Their Children
Prevention of Transmission of Mutans Streptococci From Mother to Child
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.
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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Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Caries, Dental
  • Drug: Cervitec chlorhexidine varnish
  • Drug: Duraphat fluoride varnish
  • Drug: xylitol gum from Fennobon, Finland
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
January 2006
January 2006   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
2 Months to 35 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
R01DE013534 ( U.S. NIH Grant/Contract )
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walter bretz, New York University
New York University
National Institute of Dental and Craniofacial Research (NIDCR)
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New York University
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP