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

NCT04440137 | Completed

• 1 other identifier: DRPG/08/19
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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)

Conditions

Bottle Feeding; Dental Caries in Children

Keywords

Infant; Health promotion; Program development

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Control Group

NO INTERVENTION

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).

Intervention group

EXPERIMENTAL

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

Interventions

Bottle-feeding cessation program BEHAVIORAL

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

Intervention group

Eligibility Criteria

• Age: 1 Year - 2 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Patient with medical problems
• Cleft lip or cleft palate or both
• Patient with a craniofacial anomaly

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

Faculty Of Dentistry, University of Malaya

Kuala Lumpur, Kuala Lumpur, 50603, Malaysia

Location

MeSH Terms

Conditions

Bottle Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 31, 2020
• First Posted: June 19, 2020
• Study Start: January 1, 2020
• Primary Completion: August 6, 2020
• Study Completion: May 6, 2021
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)