Effectiveness of Oral Health Promotion in Bottle Fed Children

Dental Caries in Children Clinical Trial

Official title:

Effectiveness of Oral Health Promotion in Bottle Fed Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04440137
• Other study ID #: DRPG/08/19
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: June 2021

Study information

• Verified date: June 2020
• Source: University of Malaya
• Contact: Mohamad Zawawi
• Phone: +0139736415
• Email: haziqmzh[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: June 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 3 Years

Eligibility

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

Related Conditions & MeSH terms

• Bottle Feeding
• Dental Caries
• Dental Caries in Children

Intervention

Behavioral:
• Bottle-feeding cessation program
Specific brochure and proper oral hygiene education emphasizing on the benefit of stopping bottle-feeding given to subject

Locations

Country	Name	City	State
Malaysia	Faculty Of Dentistry, University of Malaya	Kuala Lumpur	Wilayah Persekutuan Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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