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

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)

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Key information

Conditions

Bottle Feeding Behavior Dental Caries in Children Feeding Behavior

Age range

1 year–2 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty Of Dentistry, University of Malaya

Kuala Lumpur, 50603, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Malaysian citizen
Child age 12 to 24 months old
Child with bottle feeding habit (patients from Klinik Kesihatan Ibu & Anak (KKIA))
Having at least 2 upper and 2 lower incisors at the time of recruitment
A child is taken care of predominantly by their mother (housewife) or a single carer (maid/ grandmother)
The parent who can read and write in Bahasa Melayu
Full Term baby

Exclusion criteria

Patient with medical problems
Cleft lip or cleft palate or both
Patient with a craniofacial anomaly

Treatment and study plan

Bottle-feeding cessation program

Behavioral

Specific brochure and proper oral hygiene education emphasizing on the benefit of stopping bottle-feeding given to subject

Primary outcomes

To identify changes in caries incidence

Time frame: Baseline, 6 month, 12 month

After the measurement of caries experience during the first visit, subject will be seen again in period of 6 month and 12 month to measure caries incidence on both group

Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Registry information

Official study title

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

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2021
First posted: Jun 19, 2020
Registry last updated: Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed