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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06000293
Other study ID # USM/JEPeM/KK/23020194
Secondary ID NMRR ID-23-00845
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 2023
Est. completion date February 2024

Study information

Verified date August 2023
Source Universiti Sains Malaysia
Contact Munalizaini Mukhtar
Phone +60136636632
Email munalizaini2020@student.usm.my
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aimed to assess the effectiveness of strengthened anticipatory guidance (AG) used in MOH Malaysia Infant Oral Healthcare Programme in preventing early childhood caries (ECC) lesions and improving caries risk of infants in Negeri Sembilan and their primary caregiver's knowledge and practice on infant oral healthcare


Description:

This randomised control trial study will be conducted at six government Maternal and Child Health Clinics (MCHCs) in Negeri Sembilan District, Malaysia. The samples comprised of 220 primary caregivers-infant pairs (110 pairs in the intervention group, and 110 pairs in the control group). A strengthened infant oral health module named the Oral Health Infant Module Anticipatory Guidance (OHIM AG) was designed to provide anticipatory guidance to the intervention group at three-month intervals over 6 months. The control group will receive the conventional Ministry of Health Anticipatory Guidance (MOH AG). The effectiveness of OHIM AG on early signs of childhood caries lesions development, caries risk of infants, and primary caregivers's knowledge and practice on infant oral healthcare will be assessed after six months of intervention.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 220
Est. completion date February 2024
Est. primary completion date February 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Months to 12 Months
Eligibility Inclusion Criteria: - The infant and primary caregivers (parents/ caregivers) are a Malaysian citizen - Primary caregivers can read and understand Bahasa Malaysia. This is because the AG will be conducted in Bahasa Malaysia, and the questionnaires are also in Bahasa Malaysia. Exclusion Criteria: - Infants with special needs, chronic diseases or conditions (e.g., stunting, failure to thrive and low birth weight) who are at risk for oral problems (e.g., higher risk of caries due to presence of hypomineralisation and hyperplasia) and require special oral health care.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Oral health education
Anticipatory Guidance (AG) provided to the primary caregivers-infant pairs in the intervention group

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Universiti Sains Malaysia

Outcome

Type Measure Description Time frame Safety issue
Primary Early dental caries lesion and dental caries risk exposure among infants The prevalence of early dental caries lesion and dental caries risk exposure between infants in the intervention and control groups. 6 months
Primary Knowledge and practice score on infant oral health care among primary caregivers (parents/ caregivers) The knowledge and practice score on infant oral health care between primary caregivers in the intervention and control groups.
The response options for knowledge items are true, false and don't know. A score of 1 will be given to correct answers and a score of 0 for incorrect and don't know answers. A higher score indicates better knowledge.
Each practice item is given 4 response options, including a never. The remaining three responses will include one correct or appropriate practice and two incorrect or inappropriate responses. A score of 1 will be given for the correct or appropriate answers, and a score of 0 will be given for inaccurate or inappropriate and never answers. A higher score indicates better practice.
In addition to individual domain scores, an overall score for knowledge and practice on infant oral health care can be determined by dividing the summed score from knowledge and practice domains by the total possible score.
6 months
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