MedDataX Logo

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

NCT ID: NCT04440137

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2021-05-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Bottle Feeding Dental Caries in Children

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Infant Health promotion Program development

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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).

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Bottle-feeding cessation program

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bottle-feeding cessation program

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

1 Year

Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Malaya

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mohamad Haziq

Role: PRINCIPAL_INVESTIGATOR

Faculty Of Dentistry, University Of Malaya

Shani Ann Mani

Role: PRINCIPAL_INVESTIGATOR

Faculty Of Dentistry, University Of Malaya

Sharifah Wade'ah Wafa

Role: PRINCIPAL_INVESTIGATOR

Faculty Of Dentistry, University Of Malaya

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Faculty Of Dentistry, University of Malaya

Kuala Lumpur, Kuala Lumpur, Malaysia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Malaysia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DRPG/08/19

Identifier Type: -

Identifier Source: org_study_id