Bottle FeedingNCT04440137
Controlling ECC and Terminating Bottle-feeding Habits Among Toddlers Using a Modified Oral Care Package
A study testing Bottle-feeding cessation program in people with Bottle Feeding and Dental Caries in Children, run by University of Malaya at 1 site in Malaysia.
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… Read more about this study
- Who is it for?
- Ages 1 year to 2 yearsHealthy volunteers can take part
- Conditions the study is for
- Bottle Feeding, Dental Caries in Children
- What is being tested?
- Bottle-feeding cessation program
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Jan 2020to 6 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 2 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Patient with medical problems
- Cleft lip or cleft palate or both
- Patient with a craniofacial anomaly
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Faculty Of Dentistry, University of Malaya
Kuala Lumpur, Kuala Lumpur, 50603
About this study
Official title: 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)
Read the 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.
- Conditions
- Bottle Feeding, Dental Caries in Children
- Being tested
- Bottle-feeding cessation program
- Keywords
- Infant, Health promotion, Program development
- Medical subject headings
- Bottle Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bottle-feeding cessation programBehavioural
Specific brochure and proper oral hygiene education emphasizing on the benefit of stopping bottle-feeding given to subject
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Bottle-feeding cessation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 6 month, 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start1 Jan 2020
- Primary completion6 Aug 2020
- Study completion6 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bottle FeedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamad Haziq, Principal investigator, Faculty Of Dentistry, University Of MalayaShani Ann Mani, Principal investigator, Faculty Of Dentistry, University Of MalayaSharifah Wade'ah Wafa, Principal investigator, Faculty Of Dentistry, University Of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04440137
- Sponsor's protocol ID
- DRPG/08/19
- Status last verified
- Dec 2024
- First submitted
- 31 May 2020
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlling Early Childhood Caries and Terminating Bottle-feeding Habits Among Toddlers Using a Modified Oral Care Package: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04440137
- Acronym / sponsor ID
- DRPG/08/19
- Conditions
- Bottle Feeding, Dental Caries in Children
- Keywords
- Infant, Health promotion, Program development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 6 Aug 2020 (actual)
- Study completion
- 6 May 2021 (actual)
- First posted
- 19 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Bottle-feeding cessation programMother 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. |
Who may qualify
- Ages
- 1 year to 2 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (3 listed)
- Patient with medical problems
- Cleft lip or cleft palate or both
- Patient with a craniofacial anomaly
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bottle-feeding cessation programSpecific brochure and proper oral hygiene education emphasizing on the benefit of stopping bottle-feeding given to subject | Behavioural | Intervention group |
Primary outcome
To identify changes in caries incidence
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Bottle Feeding
Recruiting
The Bottle Optimization Testing Tiny Little Eaters Study
Childhood Obesity
RecruitingPhase 2/3
BabySTrong II taVNS Feeding Trial
Feeding Delays, Neonates and Term Infants
Recruiting
Positive Feeding of the Preterm Infant
Preterm Infant, Breast Feeding
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamad Haziq principal investigator
Faculty Of Dentistry, University Of Malaya
Shani Ann Mani principal investigator
Faculty Of Dentistry, University Of Malaya
Sharifah Wade'ah Wafa principal investigator
Faculty Of Dentistry, University Of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bottle-feeding cessation program in people with Bottle Feeding and Dental Caries in Children, run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To identify changes in caries incidence (time frame: Baseline, 6 month, 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.