Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00066040
Status:
COMPLETED
Last Update Posted:
2022-11-03
First Post:
2003-08-01
Brief Title:
Prevention of Transmission of Bacteria That Cause Cavities From Mothers to Their Children
Sponsor:
New York University
Organization:
New York University
Study Overview
Official Title:
Prevention of Transmission of Mutans Streptococci From Mother to Child
Status:
COMPLETED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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 250000 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DE013534 | NIH | None | httpsreporternihgovquickSearchR01DE013534 |