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

September 9, 2020 updated by: Unilever R&D

A Study to Examine the Impact of a 21day School Brushing Intervention on the Knowledge, Behaviour and Oral Health of School Children

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

2020

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • Timur
      • Jakarta, Timur, Indonesia, 13120
        • Indonesian Dental Association Jl. Utan Kayu Raya no. 46 13120
  • Nigeria
      • Lagos, Nigeria, 101014
        • Department of Restorative Dentistry Lagos University Teaching Hospital (LUTH) Idi Araba Surulere 101014

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 9 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 21 days, 8 weeks, 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline, 21 days, 8 weeks, 24 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
8 weeks and 24 weeks
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.
Baseline, 21 days, 8 weeks, 24 weeks
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.
Baseline, 21 days, 8 weeks, 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unilever R&D

Collaborators

World Dental Federation (FDI)

Investigators

  • Study Chair: Paolo Melo, Prof., Universidade do Porto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2018

Primary Completion (ACTUAL)

August 31, 2019

Study Completion (ACTUAL)

July 31, 2020

Study Registration Dates

First Submitted

June 25, 2019

First Submitted That Met QC Criteria

June 25, 2019

First Posted (ACTUAL)

June 28, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 11, 2020

Last Update Submitted That Met QC Criteria

September 9, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FDIUL-BDN-2018-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Results will only be presented as grouped data never as individual data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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