Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

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 Intervention
Caries, Dental
Drug: Cervitec chlorhexidine varnish
Drug: Duraphat fluoride varnish
Drug: xylitol gum from Fennobon, Finland

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Prevention of Transmission of Mutans Streptococci From Mother to Child

Resource links provided by NLM:


Further study details as provided by New York University:

Estimated Enrollment: 280
Study Start Date: January 2001
Study Completion Date: January 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   2 Months to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00066040

Locations
Brazil
University of Pittsburgh-Univesidade de Dao Paulo
Bauru,, Sao Paulo, Brazil
Sponsors and Collaborators
New York University
  More Information

No publications provided

Responsible Party: walter bretz, Assoc Prof, New York University
ClinicalTrials.gov Identifier: NCT00066040     History of Changes
Obsolete Identifiers: NCT00016822
Other Study ID Numbers: NIDCR-13534, R01DE013534
Study First Received: August 1, 2003
Last Updated: July 16, 2012
Health Authority: United States: Federal Government

Keywords provided by New York University:
mutans streptococci infections

Additional relevant MeSH terms:
Dental Caries
Stomatognathic Diseases
Tooth Demineralization
Tooth Diseases
Chlorhexidine
Anti-Infective Agents
Anti-Infective Agents, Local
Disinfectants
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014