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Effect of the SIMS Programme on Preschool Children's Oral Hygiene Level

NCT04339647 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 653

Last updated 2020-04-09

No results posted yet for this study

Summary

This is a cluster randomised control trial targeting 5-6-year-old children and their parents in Kampar district, Perak, Malaysia for a period of 6 months. In total, 28 preschools are randomly assigned into intervention and control group (14 preschools per group). Sample size for each group is 317 children. The intervention group receives the SIMS programme (SIMSP) which is an improved version of the usual care, while the control group receives the usual care. Usual care in defined as the existing preschool oral health programme (POHP) offered by the Ministry of Health. The SIMSP is formulated based on the recommendations from the National Oral Health Survey of Preschool Children's (2015) report. It comprises active participation of dental therapists (DT), parents and class teachers in children's oral health. The concept of the SIMSP is that improvement in oral health behaviours and oral hygiene of preschool children would result in improvement of gingival health and caries level in their permanent teeth in the long term. On the other hand, the control group involves DT visiting preschools twice a year without parental nor teachers active involvement. The scientific hypothesis of the study is that the SIMSP is more effective to improve oral hygiene level of preschool children than the POHP over 6 months. The primary objective of the study is to assess the effect of the SIMSP versus the POHP in improving oral hygiene level among 5-6-year-old children over 6 months. The secondary objectives are to assess the changes in oral health behaviours among the children and oral health literacy among parents over 6 months.

Conditions

  • Dental Plaque

Interventions

BEHAVIORAL

The SIMS programme

The intervention targets 5-6-year-old preschool children and their parents. Apart from the usual care, 5-6-year-old children receive oral health lessons and supervised daily tooth brushing (1000ppm F) at school over a period of 6 months, as well as home tooth brushing supervision by parents for 6 months. Parents/guardians attend a meeting with a DT team at school to discuss on child's oral health status, receive OHE and free toothbrush and fluoride toothpaste (1000ppm F) for child home tooth brushing, and receive 10 oral health infographic messages from DT over a period of 5 months (with printed versions available).

Sponsors & Collaborators

  • Ministry of Health, Malaysia

    collaborator OTHER_GOV

  • University of Malaya

    lead OTHER

Principal Investigators

  • Zamros YM Yusof, BDS, MSc, PhD · Faculty of Dentistry, University of Malaya, Kuala Lumpur, 50603, Malaysia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-18
Primary Completion
2019-10-17
Completion
2019-11-17

Countries

  • Malaysia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04339647 on ClinicalTrials.gov