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The Impact of a 21day School Brushing Intervention on the Knowledge, Behaviour and Oral Health of School Children

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ClinicalTrials.gov Identifier: NCT04001296
Recruitment Status : Completed
First Posted : June 28, 2019
Last Update Posted : September 11, 2020
Sponsor:
Collaborator:
World Dental Federation (FDI)
Information provided by (Responsible Party):
Unilever R&D

Tracking Information
First Submitted Date  ICMJE June 25, 2019
First Posted Date  ICMJE June 28, 2019
Last Update Posted Date September 11, 2020
Actual Study Start Date  ICMJE February 1, 2018
Actual Primary Completion Date August 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 9, 2020)
Change in reported brushing frequency and improved knowledge on recommendation to use fluoridated toothpaste [ Time Frame: Baseline, 21 days, 8 weeks, 24 weeks ]
Self-reported brushing frequency (no. of times a day) and time of day (morning / evening / other). Positive responses on use of a fluoridated toothpaste.
Original Primary Outcome Measures  ICMJE
 (submitted: June 25, 2019)
Increase in reported brushing frequency and improved knowledge on recommendation to use fluoridated toothpaste [ Time Frame: Baseline, 21 days, 8 weeks, 24 weeks ]
Self-reported brushing frequency (no. of times a day) and time of day (morning / evening / other). Positive responses on use of a fluoridated toothpaste.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2020)
Change in visible plaque and debris on teeth [ Time Frame: Baseline, 21 days, 8 weeks, 24 weeks ]
To measure the impact on oral health via plaque levels at baseline and after a 21-day school programme, 8 and 24 weeks later and compare with children and compare with children in the control group. Changes from Baseline will also be made Oral Health will be assessed by measuring plaque levels via the plaque levels via the Oral Hygiene Simplified Index (OHIs).
Original Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2019)
Reduction in visible plaque and debris on teeth [ Time Frame: Baseline, 21 days, 8 weeks, 24 weeks ]
To measure the impact on oral health via plaque levels at baseline and after a 21-day school programme, 8 and 24 weeks later and compare with children and compare with children in the control group. Changes from Baseline will also be made Oral Health will be assessed by measuring plaque levels via the plaque levels via the Oral Hygiene Simplified Index (OHIs).
Current Other Pre-specified Outcome Measures
 (submitted: September 9, 2020)
  • Alterations in brushing frequency continue beyond the end of the 21 day programme. [ Time Frame: 8 weeks and 24 weeks ]
    To evaluate the longer-term impact of the 21-day programme on knowledge/behaviour and oral health in children and knowledge/behaviour of their parents/carers after a period 8 weeks and 24 weeks (i.e. approx.. 7 months altogether). For the children, use of a questionnaire and plaque levels compared with baseline and after 21 days. For their parents/carers use of a questionnaire alone
  • The intervention influences the behaviour of parents / carers [ Time Frame: Baseline, 21 days, 8 weeks, 24 weeks ]
    To provide evidence that the 21-day school program is effective in getting parents and carers to also improve their brushing habits and to brush day and night. Assessed via use of a questionnaire and compared with baseline and compared with parents/carers in their control group.
  • Children and adults who brush more frequently report a change in their own wellbeing [ Time Frame: Baseline, 21 days, 8 weeks, 24 weeks ]
    Use of a simple 4 point scale with faces which signify different emotional states from happy to sad, compared with baseline and compared with children, parents/carers in their control group.
Original Other Pre-specified Outcome Measures
 (submitted: June 25, 2019)
  • Improvements in brushing frequency continue beyond the end of the 21 day programme. [ Time Frame: 8 weeks and 24 weeks ]
    To evaluate the longer-term impact of the 21-day programme on knowledge/behaviour and oral health in children and knowledge/behaviour of their parents/carers after a period 8 weeks and 24 weeks (i.e. approx.. 7 months altogether). For the children, use of a questionnaire and plaque levels compared with baseline and after 21 days. For their parents/carers use of a questionnaire alone
  • The intervention positively influences the behaviour of parents / carers [ Time Frame: Baseline, 21 days, 8 weeks, 24 weeks ]
    To provide evidence that the 21-day school program is effective in getting parents and carers to also improve their brushing habits and to brush day and night. Assessed via use of a questionnaire and compared with baseline and compared with parents/carers in their control group.
  • Children and adults who brush more frequently are happier with their smiles and feel more confident [ Time Frame: Baseline, 21 days, 8 weeks, 24 weeks ]
    Use of a questionnaire and compared with baseline and compared with children, parents/carers in their control group.
 
Descriptive Information
Brief Title  ICMJE The Impact of a 21day School Brushing Intervention on the Knowledge, Behaviour and Oral Health of School Children
Official Title  ICMJE A Study to Examine the Impact of a 21day School Brushing Intervention on the Knowledge, Behaviour and Oral Health of School Children
Brief Summary

In this study we aim to study the effectiveness of a specially designed 21 day Brush Day and Night programme for school children aged 6-9 which aims to establish the habit of twice a day toothbrushing for oral health.

The 21 day programme is led primarily by teachers with support from a oral health care professional.

Schools will be recruited in Indonesia and Nigeria to take part in the study. Half of the schools will run the 21 day programme with their children in school grades 1 to 3, half will act as a control.

Detailed Description

Background The World Health Organization reports that dental cavities affect 60-90% of children globally. FDI World Dental Federation and Unilever Oral Care have developed public health programmes to improve brushing habits over their 12-year partnership. The last of these (Phase III) named Brush Day & Night aimed to educate children in brushing twice daily with a fluoride toothpaste and gave useful information for a new project, Phase IV. The 21-day Brush Day & Night programme is an intense education activity designed to establish the habit of brushing day and night with a fluoride toothpaste. The programme involves daily brushing instruction and includes free toothpaste and toothbrushes.

Objective In Phase IV of the partnership, the aim is to evaluate the impact on the knowledge, behaviour and toothbrushing habits in schoolchildren aged 6-9 years old, after a 21-day school programme and compare with baseline and a control group. The enduring nature of the programme will be determined by the inclusion of 8 and 24-week time points.

Methods The study is a two-arm superiority randomized controlled trial. Clusters in this study are infant and junior schools in Indonesia and Nigeria. The study aims to recruit 20 schools, with children aged 6-9 years old, in each country.

At baseline, children in both intervention and control schools will answer a questionnaire and have their clinical oral health assessed using the Simplified Oral Hygiene Index (OHIs) and Decayed Missing and Filled Teeth (DMFT) index.

Children in the intervention schools will then take part in a structured 21-day Brush Day & Night intervention.

Children in the control schools will be provided with free toothpaste and toothbrushes but will not receive the 21-day intervention.

The questionnaires and OHIs assessment are repeated after the 21 days programme is completed and then again at 8 weeks and 24 weeks later for all participating children.

Parents/Carers/Guardians of all children will sign the informed consent and complete questionnaires on their own experience and attitudes to oral health and toothbrushing routine at each of the four times points (baseline, 21-day, 8 weeks and 24 weeks).

The study will be conducted by the National Dental Associations of Indonesia and Nigeria and was approved by the Ethics Committees of both countries.

Results:

The study is ongoing. Recruitment of schools started in Indonesia in February 2018 and in Nigeria in April 2018 for the first part of the study. This concluded in Indonesia in September 2018 and in Nigeria in November 2018. The second part of the study (the second half of the schools) started in November 2018 in Indonesia and December 2018 in Nigeria.

Conclusions:

The Investigators expect to collect all the data during 2019 and publish findings from the study by Q3 2020.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
This study is a two-arm, parallel, stratified, cluster randomised trial. Clusters in this study are infant / junior schools in Indonesia and Nigeria. Ten schools in each country will be recruited. Schools will be matched into pairs by location (urban, semi-urban, rural) and then randomised to the 'intervention' and 'control' groups. using a randomisation table.
Masking: Single (Outcomes Assessor)
Masking Description:
The data analysts / statisticians will not know whether the data they are analysing is from children in an Intervention or a Control school
Primary Purpose: Prevention
Condition  ICMJE
  • Dental Plaque
  • Behavior
  • Behavior, Health
Intervention  ICMJE Behavioral: 21 day Brush Day and Night school programme
Children participating in the 21 day Brush Day and Night school programme are provided with toothpaste and a toothbrush each and enjoy brushing instruction, supervised brushing, and the singing of songs to facilitate learn the importance of brushing day and night, and stickers and calendars to track progress. A celebration is held at the end of the programme with certificates and rewards. The programme is supported by colourful and attractive materials with bespoke cartoon characters. Parents are provided with educational leaflets.
Study Arms  ICMJE
  • Experimental: 21 day Brush Day and Night intervention
    The 21 day Brush Day and Night programme aims to instruct on and encourage twice a day brushing with a fluoridated toothpaste.
    Intervention: Behavioral: 21 day Brush Day and Night school programme
  • No Intervention: Control schools
    Schools / children who receive only toothpaste / toothbrushes, no 21 day Brush Day and Night intervention
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 9, 2020)
2020
Original Estimated Enrollment  ICMJE
 (submitted: June 25, 2019)
1800
Actual Study Completion Date  ICMJE July 31, 2020
Actual Primary Completion Date August 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Children aged in school year grades 1,2 and 3 years, aged 6-9 years
  • Be of either gender and in good general health
  • Be willing and be able (e.g. to brush teeth and understand and respond to questions) to participate in a 21-day Brush Day and Night activity at school and at home.
  • Planning on attending their currently registered school for at least the next seven months.

Exclusion Criteria:

  • Failure of the parent/carer/guardian to provide written informed consent.
  • Subjects scheduled for medical or dental procedures during the duration of the study.
  • Children who have a known allergy to any toothpaste ingredients
  • Obvious signs of gross or untreated caries or of significant periodontal disease which in the opinion of the Dentist would affect the scientific validity of the study, or if the subject were to participate in the study would affect their wellbeing.
  • Children or their family should have no affiliation (e.g. employee) with either the FDI or Unilever.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 9 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Indonesia,   Nigeria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04001296
Other Study ID Numbers  ICMJE FDIUL-BDN-2018-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Results will only be presented as grouped data never as individual data.
Responsible Party Unilever R&D
Study Sponsor  ICMJE Unilever R&D
Collaborators  ICMJE World Dental Federation (FDI)
Investigators  ICMJE
Study Chair: Paolo Melo, Prof. Universidade do Porto
PRS Account Unilever R&D
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP