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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04440137
Enrollment
60
Registered
2020-06-19
Start date
2020-01-01
Completion date
2021-05-06
Last updated
2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bottle Feeding, Dental Caries in Children

Keywords

Infant, Health promotion, Program development

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.

Interventions

BEHAVIORALBottle-feeding cessation program

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

Sponsors

University of Malaya
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

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.

Eligibility

Sex/Gender
ALL
Age
1 Years to 2 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
To identify changes in caries incidenceBaseline, 6 month, 12 monthAfter 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

Countries

Malaysia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026