Behavior Clinical Trial
Official title:
A Study to Examine the Impact of a 21day School Brushing Intervention on the Knowledge, Behaviour and Oral Health of School Children
Verified date | September 2020 |
Source | Unilever R&D |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 2020 |
Est. completion date | July 31, 2020 |
Est. primary completion date | August 31, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Years to 9 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Indonesia | Indonesian Dental Association Jl. Utan Kayu Raya no. 46 13120 | Jakarta | Timur |
Nigeria | Department of Restorative Dentistry Lagos University Teaching Hospital (LUTH) Idi Araba Surulere 101014 | Lagos |
Lead Sponsor | Collaborator |
---|---|
Unilever R&D | World Dental Federation (FDI) |
Indonesia, Nigeria,
GREENE JC, VERMILLION JR. THE SIMPLIFIED ORAL HYGIENE INDEX. J Am Dent Assoc. 1964 Jan;68:7-13. — View 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 1:3-6. doi: 10.1111/idj.12404. Epub 2018 Mar 24. — View 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 1:7-16. doi: 10.1111/idj.12410. Epub 2018 Apr 16. — View 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 1:17-19. doi: 10.1111/idj.12403. Epub 2018 Mar 22. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Alterations in brushing frequency continue beyond the end of the 21 day programme. | 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 | |
Other | The intervention influences the behaviour of parents / carers | 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 | |
Other | Children and adults who brush more frequently report a change in their own wellbeing | 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 | |
Primary | 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. | Baseline, 21 days, 8 weeks, 24 weeks | |
Secondary | 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). | Baseline, 21 days, 8 weeks, 24 weeks |
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