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

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ClinicalTrials.gov Identifier: NCT04339647
Recruitment Status : Completed
First Posted : April 9, 2020
Last Update Posted : April 9, 2020
Sponsor:
Collaborator:
Ministry of Health, Malaysia
Information provided by (Responsible Party):
University of Malaya

Brief 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.

Condition or disease Intervention/treatment Phase
Dental Plaque Behavioral: The SIMS programme Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 653 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Cluster Randomised Controlled Trial
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of the Community-based SIMS Programme on Preschool Children's Oral Hygiene Level: A Cluster Randomised Control Trial
Actual Study Start Date : February 18, 2019
Actual Primary Completion Date : October 17, 2019
Actual Study Completion Date : November 17, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: The SIMS Programme
The SIMS programme is a community-based intervention which improvised the usual care (defined as the existing preschool oral health programme) offered by the Ministry of Health. The target group is 5-6-year-old preschool children and their parents. Apart from the usual care, the 5-6-year-old children receive interventions carried out by teacher in school and home tooth brushing supervision by parents. In addition, parents/guardians will receive OHE from the DT team, free toothbrush and toothpaste (1000ppm F) for child home tooth brushing and supervised child home tooth brushing for 6 months.
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).

No Intervention: Control
The control group receives the usual care from the preschool oral health programme. The usual care is described as a DT team visiting the school to do an oral examination, provides OHE to the children, and applies fluoride varnish (20,000 ppmF) twice/year.



Primary Outcome Measures :
  1. The mean decrement in plaque score assessed using the Oral Cleanliness Index [ Time Frame: 6 months ]
    The mean decrement in plaque score from baseline to follow up between the intervention and control group will be assessed. Assessment for the presence of visible plaque will involve examining the labial surfaces of upper right to upper left primary canines. Each of the surface is assessed by scoring; 0 = teeth appear clean, 1 = a little plaque visible (existence of plaque around the labial cervical margins and covering < ½ of labial tooth surfaces), 2 = substantial amount of plaque visible (plaque covering > ½ labial tooth surfaces), and 9 = assessment cannot be made (there is no teeth in both anterior segments for plaque assessment). Total score is the sum of scores from the 6 surfaces. Mean decrement score is obtained by subtracting mean score at follow up from mean score at baseline. Finally, mean decrement scores of intervention and control group are compared.


Secondary Outcome Measures :
  1. Changes in child's oral health behaviours assessed using a self-reported questionnaire by parents [ Time Frame: 6 months ]
    Changes in the prevalence of good oral health behaviours. The changes are recorded as follows: Brushing teeth with fluoride toothpaste (yes, no), tooth brushing frequency (at least 2x/day, < 2x/day), frequency of monitoring child's tooth brushing (daily, do not monitor), bottle feeding (yes, no), bottle feeding frequency (daily, infrequent), bottle feeding at night (yes, no), sugar intake (up to 4x/day, > 5x/day), dental visit (< 1 yr, between 1-2 yr, > 2 yr)

  2. The mean increment of oral health literacy score of parents/guardians assessed using The Dental Health Literacy Assessment Index (DHLAI) [ Time Frame: 6 months ]
    The DHLAI consists of 3 domains; (a) Oral Health Knowledge domain (12 items). Each item is assessed by one correct answer from 4 options. Total score = sum scores of correct answers with score range from 0-12; (b) Comprehension domain (5 items). Each item is scored by true/false answer options. Total score = the sum scores of correct answers with score range from 0-5; (c) Skills and Motivation domain (39 items). Each item is assessed using a 5-point Likert scale (strongly disagree to strongly agree). Total score = sum scores of all items with score range from 0-39. Total score of OHL = sum of scores from the 3 domains with score range from 0-56. Mean increment scores of total OHL and the 3 domains are calculated by subtracting the respective scores at baseline from follow up scores. The mean scores were compared between intervention and control group.



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Ages Eligible for Study:   5 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Children who are healthy
  • Preschool children who can understand Malay language
  • Parents who can speak and write in Malay language

Exclusion Criteria:

  • Children with chronic medical conditions, dental/oral developmental conditions, long term medications, and physical disability

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): NCT04339647


Locations
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Malaysia
State Education Department
Ipoh, Perak, Malaysia, 30640
Sponsors and Collaborators
University of Malaya
Ministry of Health, Malaysia
Investigators
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Principal Investigator: Zamros YM Yusof, BDS, MSc, PhD Faculty of Dentistry, University of Malaya, Kuala Lumpur, 50603, Malaysia
Additional Information:
Publications:
Freeman, R, Gibson, B, Humphris, GM, Leonard, H, Yuan, S & Whelton, H. School-based health education programmes, health-learning capacity and child oral health-related quality of life. Health Education Journal. 2016;75(6):698-711.
Pine CM. Designing school programmes to be effective vehicles for changing oral hygiene behaviour. Int Dent J. 2007;57(S5):377-81.
. Ludke RL, Kudel I, and Weber DL, Dental Health Literacy Assessment Instrument, U.o. Cincinnati, Editor. 2008.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Malaya
ClinicalTrials.gov Identifier: NCT04339647    
Other Study ID Numbers: IIRG035A
First Posted: April 9, 2020    Key Record Dates
Last Update Posted: April 9, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be kept at the Faculty of Dentistry, University of Malaya, 50603, Kuala Lumpur, Malaysia. Data can be shared upon request and is subjected to the data protection regulations.

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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 University of Malaya:
Preschool
Children
Dental plaque
Oral health behaviour
Health literacy
Additional relevant MeSH terms:
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Dental Plaque
Dental Deposits
Tooth Diseases
Stomatognathic Diseases