The Impact of Anticipatory Guidance on Early Childhood Caries: a Quasi-experimental Study

NCT ID: NCT03478748

Last Updated: 2018-03-27

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

478 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-02

Study Completion Date

2017-12-15

Brief Summary

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

This study aimed to compare the impact of anticipatory guidance on the caries incidence of 2-3-year-old preschool children and their 4-6-year-old siblings, as well as on their mothers' oral health literacy, as compared to the conventional Ministry of Health (MOH) programme.

Detailed Description

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

This quasi-experimental study was conducted at two government dental clinics in Batu Pahat District, Malaysia. The samples comprised of 478 mother-child-sibling trios (233 families in the intervention group, and 245 families in the control group). An oral health package named the Family Dental Wellness Programme (FDWP) was designed to provide anticipatory guidance to the intervention group at six-month intervals over three years. The control group received the standard MOH oral health education activities. The impact of FDWP on net caries increment, caries prevented fraction, and mother's oral health literacy was assessed after three years of intervention.

Conditions

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

Dental Caries in Children

Study Design

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

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

The model is an oral health education package that covers the following aspects: (i) cognitive component (for example, the provision of basic oral health knowledge using an anticipatory guidance technique); (ii) psychomotor component (for example, the demonstration of basic oral health skills such as toothbrushing skills with a hands-on practical); and (iii) attitude component (activities that help to improve the children's attitude towards oral health). Children (along with their older siblings and mothers) in the study group were required to make six-monthly visits to the dental clinic in the three-year study period. Those in the control group received the conventional Ministry of Health programme.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Both investigators and participants knew about the intervention and who were involved.

Study Groups

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

one-to-one dental health education

Conventional oral health education programme that mainly focuses at child level, which has been the normal practice at the Ministry of Health, were provided to the control participants.

Group Type ACTIVE_COMPARATOR

Dental health education

Intervention Type OTHER

Anticipatory guidance given to mothers to promote their children's oral health.

anticipatory guidance technique

Anticipatory guidance technique were applied where appropriate dental health education (according to the children's milestones) were provided to mothers and their children.

Group Type EXPERIMENTAL

Dental health education

Intervention Type OTHER

Anticipatory guidance given to mothers to promote their children's oral health.

Interventions

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

Dental health education

Anticipatory guidance given to mothers to promote their children's oral health.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Anticipatory guidance

Eligibility Criteria

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

Inclusion Criteria

* Children between the age of 2-3 years old
* Older sibling aged 4 to 6 years categorized as having high caries risk based on a Caries Risk Assessment tool adapted from the American Association of Paediatric Dentistry
* Mothers who were willing to participate in the study

Exclusion Criteria

• Medically compromised children
Minimum Eligible Age

2 Years

Maximum Eligible Age

6 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.

Norintan Ab Murat

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Norintan Ab Murat, PhD

Role: STUDY_CHAIR

University of Malaya

Locations

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

Batu Pahat Dental Clinic

Batu Pahat, Johor, Malaysia

Site Status

Countries

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

Malaysia

References

Explore related publications, articles, or registry entries linked to this study.

Ismail A, Razak IA, Ab-Murat N. The impact of anticipatory guidance on early childhood caries: a quasi-experimental study. BMC Oral Health. 2018 Jul 27;18(1):126. doi: 10.1186/s12903-018-0589-0.

Reference Type DERIVED
PMID: 30053849 (View on PubMed)

Other Identifiers

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

DFCO1505/0005P

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.