Clinical trial NCT04440137: Controlling ECC and Terminating Bottle-feeding Habits Among Toddlers Using a Modified Oral Care Package
Official title: Controlling Early Childhood Caries and Terminating Bottle-feeding Habits Among Toddlers Using a Modified Oral Care Package: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bottle Feeding
Dental Caries in Children
Keywords: Infant
Health promotion
Program development
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2020-06-19
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1. Collection of Samples Randomization will be carried out.
2. Research Briefing and Questionnaire Distribution Research briefing will be carried out and details of the study will be explained.
3. Questionnaire Collection and Dental Examination at baseline

   1. After obtaining informed consent, questionnaires will be distributed.
   2. Caries experience of children will be recorded using ICDAS score. Caries experience also will be recorded in DMFT with cavitated and DMFT without cavitated.
   3. Intervention group will be provided with intervention brochure, kid toothbrush and toothpaste and a free-flow cup. Control group will receive brochure with standard of care info and kid toothbrush and toothpaste.
   4. An electronic form of OHP, will be given every 3 months to both group
   5. Dental check-up will be done every 6 months at the respective woman and child clinic.
   6. After a period of 1 year, the patient will be given a questionnaire again and dental check-up to compare any difference.
Primary purpose: PREVENTION

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 (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.

Eligibility criteria: 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

Primary outcomes:
measure: To identify changes in caries incidence
timeFrame: Baseline, 6 month, 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: Faculty Of Dentistry, University of Malaya
state: Wilayah Persekutuan Kuala Lumpur
Study officials:
affiliation: Faculty Of Dentistry, University Of Malaya
name: Mohamad Haziq
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty Of Dentistry, University Of Malaya
name: Shani Ann Mani
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty Of Dentistry, University Of Malaya
name: Sharifah Wade'ah Wafa
role: PRINCIPAL_INVESTIGATOR
References: