Effectiveness of Oral Health Promotion in Bottle Fed Children

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effectiveness of Oral Health Promotion in Bottle Fed Children

Conditions
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Bottle Feeding, Dental Caries in Children

Intervention / Treatment
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* Behavioral: Bottle-feeding cessation program


Participation Criteria
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Eligibility Criteria
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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 Child is taken care predominantly by their mother (housewife) 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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Collection of Samples Randomization will be carried out. Research Briefing and Questionnaire Distribution Research briefing will be carried out and details of the study will be explained. Questionnaire Collection and Dental Examination at baseline After obtaining informed consent, questionnaires will be distributed. Caries experience of children will be recorded using ICDAS score. Caries experience also will be recorded in DMFT with cavitated and DMFT without cavitated. 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. An electronic form of OHP, will be given every 3 months to both group Dental check-up will be done every 6 months at the respective woman and child clinic. After a period of 1 year, the patient will be given a questionnaire again and dental check-up to compare any difference.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>Mother of children will receive a brochure with a standard of care info (with only essential information regarding the harmful effect of bottle feeding) and kid toothbrush and toothpaste (1000ppm of fluoride). | |
| Experimental: Intervention group<br>Mother of the children will be provided with intervention brochure (which include detailed information regarding the harmful effect of bottle feeding), kid toothbrush and toothpaste (1000ppm of fluoride) and a sippy cup. | Behavioral: Bottle-feeding cessation program<br>* Specific brochure and proper oral hygiene education emphasizing on the benefit of stopping bottle-feeding given to subject<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To identify changes in caries incidence | 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 | Baseline, 6 month, 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infant, Health promotion, Program development