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Trial record 67 of 1215 for:    tooth decay

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

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ClinicalTrials.gov Identifier: NCT03478748
Recruitment Status : Completed
First Posted : March 27, 2018
Last Update Posted : March 27, 2018
Sponsor:
Information provided by (Responsible Party):
Norintan Ab Murat, University of Malaya

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Dental Caries in Children Other: Dental health education Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 478 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Masking Description: Both investigators and participants knew about the intervention and who were involved.
Primary Purpose: Prevention
Official Title: The Impact of Anticipatory Guidance on Early Childhood Caries: a Quasi-experimental Study
Actual Study Start Date : January 2, 2015
Actual Primary Completion Date : December 15, 2017
Actual Study Completion Date : December 15, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Other: Dental health education
Anticipatory guidance given to mothers to promote their children's oral health.
Other Name: Anticipatory guidance

Experimental: 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.
Other: Dental health education
Anticipatory guidance given to mothers to promote their children's oral health.
Other Name: Anticipatory guidance




Primary Outcome Measures :
  1. Incidence of dental caries [ Time Frame: Baseline and 3 years ]
    Change from baseline dental caries prevalence at 3 years using visual and tactile examination


Secondary Outcome Measures :
  1. Mothers' oral health literacy [ Time Frame: Baseline and 3 years ]
    Changes in mothers' oral health literacy at 3 year follow up using a validated Dental Health Literacy instruments



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03478748


Locations
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Malaysia
Batu Pahat Dental Clinic
Batu Pahat, Johor, Malaysia, 83100
Sponsors and Collaborators
University of Malaya
Investigators
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Study Chair: Norintan Ab Murat, PhD University of Malaya

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Norintan Ab Murat, Associate Professor, University of Malaya
ClinicalTrials.gov Identifier: NCT03478748     History of Changes
Other Study ID Numbers: DFCO1505/0005P
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Norintan Ab Murat, University of Malaya:
Dental caries
Oral health literacy

Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases