Dental PlaqueNCT04001296
The Impact of a 21day School Brushing Intervention on the Knowledge, Behaviour and Oral Health of School Children
A study testing 21 day Brush Day and Night school programme in people with Dental Plaque and Behavior, run by Unilever R&D at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Plaque, Behavior, Behavior, Health
- What is being tested?
- 21 day Brush Day and Night school programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,020 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Feb 2018to 31 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Indonesia1 site
Indonesian Dental Association Jl. Utan Kayu Raya no. 46 13120
Jakarta, Timur, 13120
Nigeria1 site
Department of Restorative Dentistry Lagos University Teaching Hospital (LUTH) Idi Araba Surulere 101014
Lagos, 101014
About this study
Official title: 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.
Read the 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.
- Conditions
- Dental Plaque, Behavior, Behavior, Health
- Being tested
- 21 day Brush Day and Night school programme
- Keywords
- Behavior, Toothbrushing, Toothpastes, Dental Caries, Education, Dental
- Medical subject headings
- Dental Plaque, Behavior, Health Behavior, Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
21 day Brush Day and Night school programmeBehavioural
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 group | Role | What they receive |
|---|---|---|
| 21 day Brush Day and Night intervention | Experimental | The 21 day Brush Day and Night programme aims to instruct on and encourage twice a day brushing with a fluoridated toothpaste. Receives: Behavioral: 21 day Brush Day and Night school programme |
| Control schools | No intervention | Schools / children who receive only toothpaste / toothbrushes, no 21 day Brush Day and Night intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 21 days, 8 weeks, 24 weeks
Secondary outcomes (1)
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).
Measured: Baseline, 21 days, 8 weeks, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2019
- Study start1 Feb 2018
- Primary completion31 Aug 2019
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Dental PlaqueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,020 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unilever R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- World Dental Federation (FDI)
- Responsible party
- Sponsor
- Investigators
- Paolo Melo, Prof., Study chair, Universidade do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04001296
- Sponsor's protocol ID
- FDIUL-BDN-2018-01
- Status last verified
- Sep 2020
- First submitted
- 25 Jun 2019
- Last updated
- 11 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Results will only be presented as grouped data never as individual data.
Publications
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.
PubMed 29573414Melo 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.
PubMed 29660791Melo 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.
PubMed 29569263GREENE 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.
PubMed 14076341Melo 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.
PubMed 32130186
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Examine the Impact of a 21day School Brushing Intervention on the Knowledge, Behaviour and Oral Health of School Children
- ClinicalTrials.gov ID
- NCT04001296
- Acronym / sponsor ID
- FDIUL-BDN-2018-01
- Conditions
- Dental Plaque, Behavior, Behavior, Health
- Keywords
- Behavior, Toothbrushing, Toothpastes, Dental Caries, Education, Dental
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,020 participants (actual)
- Lead sponsor
- Unilever R&DIndustry (pharma, biotech, devices)
- Collaborators
- World Dental Federation (FDI)
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 28 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 21 day Brush Day and Night intervention | Experimental | Behavioral: 21 day Brush Day and Night school programmeThe 21 day Brush Day and Night programme aims to instruct on and encourage twice a day brushing with a fluoridated toothpaste. |
| Control schools | No intervention | –Schools / children who receive only toothpaste / toothbrushes, no 21 day Brush Day and Night intervention |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 21 day Brush Day and Night school programmeChildren 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. | Behavioural | 21 day Brush Day and Night intervention |
Primary outcome
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.
1 secondary outcome
Change in visible plaque and debris on teeth
Time frame: Baseline, 21 days, 8 weeks, 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2020.
- Background: PubMed 29573414Kell 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.
- Background: PubMed 29660791Melo 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.
- Background: PubMed 29569263Melo 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.
- Background: PubMed 14076341GREENE 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.
- Derived from this study: PubMed 32130186Melo 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.
- Individual participant dataSharing planned: No. Results will only be presented as grouped data never as individual data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paolo Melo, Prof. study chair
Universidade do Porto
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 21 day Brush Day and Night school programme in people with Dental Plaque and Behavior, run by Unilever R&D at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Indonesia, Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in reported brushing frequency and improved knowledge on recommendation to use fluoridated toothpaste (time frame: Baseline, 21 days, 8 weeks, 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04001296, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2020.