Clinical Trials Directory

Trials / Completed

CompletedNCT04440137

Controlling ECC and Terminating Bottle-feeding Habits Among Toddlers Using a Modified Oral Care Package

Controlling Early Childhood Caries and Terminating Bottle-feeding Habits Among Toddlers Using a Modified Oral Care Package: a Randomised Controlled Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
60 (actual)
Sponsor
University of Malaya · Academic / Other
Sex
All
Age
1 Year – 2 Years
Healthy volunteers
Accepted

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 (87.1% 1995, 76.2% 2005 and 71.3% 2015) \[NOHPS 2015\], yet the difference is just 15.8% 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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALBottle-feeding cessation programSpecific brochure and proper oral hygiene education emphasizing on the benefit of stopping bottle-feeding given to subject

Timeline

Start date
2020-01-01
Primary completion
2020-08-06
Completion
2021-05-06
First posted
2020-06-19
Last updated
2024-12-09

Locations

1 site across 1 country: Malaysia

Source: ClinicalTrials.gov record NCT04440137. Inclusion in this directory is not an endorsement.