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
|Condition or disease||Intervention/treatment||Phase|
|Dental Plaque||Behavioral: The SIMS programme||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||653 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Cluster Randomised Controlled Trial|
|Masking:||Single (Outcomes Assessor)|
|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|
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.
- 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.
- 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)
- 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.
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
|State Education Department|
|Ipoh, Perak, Malaysia, 30640|
|Principal Investigator:||Zamros YM Yusof, BDS, MSc, PhD||Faculty of Dentistry, University of Malaya, Kuala Lumpur, 50603, Malaysia|