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

Primary Purpose

Dental Plaque, Behavior, Behavior, Health

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
21 day Brush Day and Night school programme
Sponsored by
Unilever R&D
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Plaque focused on measuring Behavior, Toothbrushing, Toothpastes, Dental Caries, Education, Dental

Eligibility Criteria

6 Years - 9 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

21 day Brush Day and Night intervention

Control schools

Arm Description

The 21 day Brush Day and Night programme aims to instruct on and encourage twice a day brushing with a fluoridated toothpaste.

Schools / children who receive only toothpaste / toothbrushes, no 21 day Brush Day and Night intervention

Outcomes

Primary Outcome Measures

Change in reported brushing frequency and improved knowledge on recommendation to use fluoridated toothpaste
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

Change in visible plaque and debris on teeth
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).

Full Information

First Posted
June 25, 2019
Last Updated
September 9, 2020
Sponsor
Unilever R&D
Collaborators
World Dental Federation (FDI)
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1. Study Identification

Unique Protocol Identification Number
NCT04001296
Brief Title
The Impact of a 21day School Brushing Intervention on the Knowledge, Behaviour and Oral Health of School Children
Official Title
A Study to Examine the Impact of a 21day School Brushing Intervention on the Knowledge, Behaviour and Oral Health of School Children
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
August 31, 2019 (Actual)
Study Completion Date
July 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unilever R&D
Collaborators
World Dental Federation (FDI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Plaque, Behavior, Behavior, Health
Keywords
Behavior, Toothbrushing, Toothpastes, Dental Caries, Education, Dental

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
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
Allocation
Randomized
Enrollment
2020 (Actual)

8. Arms, Groups, and Interventions

Arm Title
21 day Brush Day and Night intervention
Arm Type
Experimental
Arm Description
The 21 day Brush Day and Night programme aims to instruct on and encourage twice a day brushing with a fluoridated toothpaste.
Arm Title
Control schools
Arm Type
No Intervention
Arm Description
Schools / children who receive only toothpaste / toothbrushes, no 21 day Brush Day and Night intervention
Intervention Type
Behavioral
Intervention Name(s)
21 day Brush Day and Night school programme
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in reported brushing frequency and improved knowledge on recommendation to use fluoridated toothpaste
Description
Self-reported brushing frequency (no. of times a day) and time of day (morning / evening / other). Positive responses on use of a fluoridated toothpaste.
Time Frame
Baseline, 21 days, 8 weeks, 24 weeks
Secondary Outcome Measure Information:
Title
Change in visible plaque and debris on teeth
Description
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).
Time Frame
Baseline, 21 days, 8 weeks, 24 weeks
Other Pre-specified Outcome Measures:
Title
Alterations in brushing frequency continue beyond the end of the 21 day programme.
Description
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
Time Frame
8 weeks and 24 weeks
Title
The intervention influences the behaviour of parents / carers
Description
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.
Time Frame
Baseline, 21 days, 8 weeks, 24 weeks
Title
Children and adults who brush more frequently report a change in their own wellbeing
Description
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.
Time Frame
Baseline, 21 days, 8 weeks, 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paolo Melo, Prof.
Organizational Affiliation
Universidade do Porto
Official's Role
Study Chair
Facility Information:
Facility Name
Indonesian Dental Association Jl. Utan Kayu Raya no. 46 13120
City
Jakarta
State/Province
Timur
ZIP/Postal Code
13120
Country
Indonesia
Facility Name
Department of Restorative Dentistry Lagos University Teaching Hospital (LUTH) Idi Araba Surulere 101014
City
Lagos
ZIP/Postal Code
101014
Country
Nigeria

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Results will only be presented as grouped data never as individual data.
Citations:
PubMed Identifier
29573414
Citation
Kell K, Aymerich MA, Horn V. FDI-Unilever Brush Day & Night partnership: 12 years of improving behaviour for better oral health. Int Dent J. 2018 May;68 Suppl 1(Suppl 1):3-6. doi: 10.1111/idj.12404. Epub 2018 Mar 24.
Results Reference
background
PubMed Identifier
29660791
Citation
Melo P, Fine C, Malone S, Frencken JE, Horn V. The effectiveness of the Brush Day and Night programme in improving children's toothbrushing knowledge and behaviour. Int Dent J. 2018 May;68 Suppl 1(Suppl 1):7-16. doi: 10.1111/idj.12410. Epub 2018 Apr 16.
Results Reference
background
PubMed Identifier
29569263
Citation
Melo P, Fine C, Malone S, Horn V. Brush Day & Night Phase III to Phase IV: ensuring that good oral health habits are sustainable. Int Dent J. 2018 May;68 Suppl 1(Suppl 1):17-19. doi: 10.1111/idj.12403. Epub 2018 Mar 22.
Results Reference
background
PubMed Identifier
14076341
Citation
GREENE JC, VERMILLION JR. THE SIMPLIFIED ORAL HYGIENE INDEX. J Am Dent Assoc. 1964 Jan;68:7-13. doi: 10.14219/jada.archive.1964.0034. No abstract available.
Results Reference
background
PubMed Identifier
32130186
Citation
Melo P, Malone S, Rao A, Fine C. A 21-Day School-Based Toothbrushing Intervention in Children Aged 6 to 9 Years in Indonesia and Nigeria: Protocol for a Two-Arm Superiority Randomized Controlled Trial. JMIR Res Protoc. 2020 Feb 21;9(2):e14156. doi: 10.2196/14156.
Results Reference
derived
Links:
URL
https://www.unilever.com/Images/slp_5-levers-for-change_tcm244-414399_en.pdf.
Description
Unilever: Five Levers for Behaviour Change model

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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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