Ignite Creation Date:
2024-05-06 @ 2:51 PM
Last Modification Date:
2024-10-26 @ 1:38 PM
Study NCT ID:
NCT04440137
Status:
UNKNOWN
Last Update Posted:
2020-06-19
First Post:
2020-05-31
Brief Title:
Effectiveness of Oral Health Promotion in Bottle Fed Children
Sponsor:
University of Malaya
Organization:
University of Malaya
Study Overview
Official Title:
Effectiveness of Oral Health Promotion in Bottle Fed Children
Status:
UNKNOWN
Status Verified Date:
2020-06
Last Known Status:
RECRUITING
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:
This study will evaluate the effectiveness of oral health promotion in the prevention of ECC early childhood caries in bottle-fed children Half of the patient will receive oral health promotion which emphasizing more on the benefit of stopping the bottle feeding habit a free-flow cup and oral hygiene kit which include a toothbrush toothpaste 1000ppm fluoride The other half of the patient will receive standard of care oral hygiene promotion and oral hygiene kit which include a toothbrush toothpaste 1000ppm fluoride
Detailed Description:
In Malaysia even though there are decreasing trend in caries prevalence from a survey conduct in 1995 to 2015 871 1995 762 2005 and 713 2015 NOHPS 2015 yet the difference is just 158 in a period of 20 years One of the factors which contribute to the development of ECC in children in prolonged bottle-feeding Many literatures had mentioned association of bottle feeding and ECC however there are no controlled studies done on the effect of bottle feeding and ECC Despite antenatal oral health promotion program done by Ministry of Health Malaysia and incorporation of oral hygiene education and oral hygiene instruction during dental visit the prevalence of ECC remains high This study will provide evidence regarding the effectiveness of oral health promotion in preventing early childhood caries by early termination of bottle feeding in toddlers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None