Effectiveness of Oral Health Promotion in Bottle Fed Children
Primary Purpose
Bottle Feeding, Dental Caries in Children
Status
Unknown status
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Bottle-feeding cessation program
Sponsored by
About this trial
This is an interventional prevention trial for Bottle Feeding focused on measuring Infant, Health promotion, Program development
Eligibility Criteria
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
Sites / Locations
- Faculty Of Dentistry, University of MalayaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control Group
Intervention group
Arm Description
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).
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04440137
Brief Title
Effectiveness of Oral Health Promotion in Bottle Fed Children
Official Title
Effectiveness of Oral Health Promotion in Bottle Fed Children
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
June 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Malaya
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bottle Feeding, Dental Caries in Children
Keywords
Infant, Health promotion, Program development
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Collection of Samples Randomization will be carried out.
Research Briefing and Questionnaire Distribution Research briefing will be carried out and details of the study will be explained.
Questionnaire Collection and Dental Examination at baseline
After obtaining informed consent, questionnaires will be distributed.
Caries experience of children will be recorded using ICDAS score. Caries experience also will be recorded in DMFT with cavitated and DMFT without cavitated.
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.
An electronic form of OHP, will be given every 3 months to both group
Dental check-up will be done every 6 months at the respective woman and child clinic.
After a period of 1 year, the patient will be given a questionnaire again and dental check-up to compare any difference.
Masking
Participant
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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).
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Bottle-feeding cessation program
Intervention Description
Specific brochure and proper oral hygiene education emphasizing on the benefit of stopping bottle-feeding given to subject
Primary Outcome Measure Information:
Title
To identify changes in caries incidence
Description
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
Time Frame
Baseline, 6 month, 12 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamad Zawawi
Phone
+0139736415
Email
haziqmzh@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamad Haziq
Organizational Affiliation
Faculty Of Dentistry, University Of Malaya
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shani Ann Mani
Organizational Affiliation
Faculty Of Dentistry, University Of Malaya
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sharifah Wade'ah Wafa
Organizational Affiliation
Faculty Of Dentistry, University Of Malaya
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty Of Dentistry, University of Malaya
City
Kuala Lumpur
State/Province
Wilayah Persekutuan Kuala Lumpur
ZIP/Postal Code
50603
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Puan Norazlinda
Phone
+603 7967 4802
Ext
2476
Email
norazlinda@um.edu.my
First Name & Middle Initial & Last Name & Degree
Mohamad Haziq Mohamad zawawi
First Name & Middle Initial & Last Name & Degree
Shani Ann Mani
First Name & Middle Initial & Last Name & Degree
Sharifah Wade'ah W Wafa S.S.T
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of Oral Health Promotion in Bottle Fed Children
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