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

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)

Study Overview

• Status: Completed
• Conditions: Dental Caries in Children; Bottle Feeding
• Intervention / Treatment: Behavioral: Bottle-feeding cessation program

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Wilayah Persekutuan Kuala Lumpur
    • Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia, 50603
      • Faculty Of Dentistry, University of Malaya

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 3 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; 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; 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; Specific brochure and proper oral hygiene education emphasizing on the benefit of stopping bottle-feeding given to subject

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Malaya
• Investigators: Principal Investigator: Mohamad Haziq, Faculty Of Dentistry, University of Malaya; Principal Investigator: Shani Ann Mani, Faculty Of Dentistry, University of Malaya; Principal Investigator: Sharifah Wade'ah Wafa, Faculty Of Dentistry, University of Malaya

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): August 6, 2020
• Study Completion (Actual): May 6, 2021

Study Registration Dates

• First Submitted: May 31, 2020
• First Submitted That Met QC Criteria: June 17, 2020
• First Posted (Actual): June 19, 2020

Study Record Updates

• Last Update Posted (Actual): December 9, 2024
• Last Update Submitted That Met QC Criteria: December 4, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Health promotion; Infant; Program development
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Demineralization; Dental Caries
• Other Study ID Numbers: DRPG/08/19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No