Controlling ECC and Terminating Bottle-feeding Habits Among Toddlers Using a Modified Oral Care P… (NCT04440137) | Clinical Trial Compass
CompletedNot Applicable
Controlling ECC and Terminating Bottle-feeding Habits Among Toddlers Using a Modified Oral Care Package
Malaysia60 participantsStarted 2020-01-01
Plain-language 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)
Who can participate
Age range
1 Year – 2 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.