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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
walter bretz, New York University
ClinicalTrials.gov Identifier:
NCT00066040
First received: August 1, 2003
Last updated: July 16, 2012
Last verified: July 2012

August 1, 2003
July 16, 2012
January 2001
January 2006   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00066040 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Caries, Dental
  • Drug: Cervitec chlorhexidine varnish
  • Drug: Duraphat fluoride varnish
  • Drug: xylitol gum from Fennobon, Finland
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
280
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
Both
2 Months to 35 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00066040
NIDCR-13534, R01DE013534
Yes
walter bretz, New York University
New York University
National Institute of Dental and Craniofacial Research (NIDCR)
Not Provided
New York University
July 2012

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