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

Not Applicable

Completed

• Conditions: Bottle Feeding; Dental Caries in Children
• Interventions: Behavioral: Bottle-feeding cessation program

• Registration Number: NCT04440137
• Lead Sponsor: University of Malaya

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.

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2020-05-31
• Study First Submitted QC: 2020-06-17
• Study First Posted: 2020-06-19
• Primary Completion: 2020-08-06
• Study Completion: 2021-05-06
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Bottle-feeding cessation program	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.

Primary Outcome Measures

Name	Time	Method
To identify changes in caries incidence	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

Trial Locations

Locations (1)

Faculty Of Dentistry, University of Malaya; 🇲🇾 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia