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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

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.


Condition or disease Intervention/treatment Phase
Dental Plaque Behavior Behavior, Health Behavioral: 21 day Brush Day and Night school programme Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2020 participants
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
Official Title: A Study to Examine the Impact of a 21day School Brushing Intervention on the Knowledge, Behaviour and Oral Health of School Children
Actual Study Start Date : February 1, 2018
Actual Primary Completion Date : August 31, 2019
Actual Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dental Health

Arm Intervention/treatment
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.
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.

No Intervention: Control schools
Schools / children who receive only toothpaste / toothbrushes, no 21 day Brush Day and Night intervention



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).


Other Outcome Measures:
  1. 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


  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT04001296


Locations
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Indonesia
Indonesian Dental Association Jl. Utan Kayu Raya no. 46 13120
Jakarta, Timur, Indonesia, 13120
Nigeria
Department of Restorative Dentistry Lagos University Teaching Hospital (LUTH) Idi Araba Surulere 101014
Lagos, Nigeria, 101014
Sponsors and Collaborators
Unilever R&D
World Dental Federation (FDI)
Investigators
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Study Chair: Paolo Melo, Prof. Universidade do Porto
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Unilever R&D
ClinicalTrials.gov Identifier: NCT04001296    
Other Study ID Numbers: FDIUL-BDN-2018-01
First Posted: June 28, 2019    Key Record Dates
Last Update Posted: September 11, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Results will only be presented as grouped data never as individual data.

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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 Unilever R&D:
Behavior
Toothbrushing
Toothpastes
Dental Caries
Education, Dental
Additional relevant MeSH terms:
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Dental Plaque
Dental Deposits
Tooth Diseases
Stomatognathic Diseases