|- candidate number||15550|
|- NTR Number||NTR4208|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||14-okt-2013|
|- Secondary IDs||ACTA 2013 Master CE-8 |
|- Public Title||The effect of an oral photograph showing dental plaque on oral health behavior|
|- Scientific Title||The effect of a dental plaque fluorescence photograph on oral health behavior|
|- ACRONYM||Motivation with a QLF photo|
|- hypothesis||Individual oral hygiene instructions based on visible plaque on an oral photograph of ones own dentition adjunct to a school oral health education lesson provides an added benefit to receiving only the school oral health education lesson.|
|- Healt Condition(s) or Problem(s) studied||Periodontal health, Motivation, |
|- Inclusion criteria||children attending group 7 of 8 of dutch elementary school|
|- Exclusion criteria||no consent|
unable to open mouth
|- mec approval received||no|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||2-jan-2014|
|- planned closingdate||31-dec-2014|
|- Target number of participants||212|
|- Interventions||All children receive a public health education program on oral health 'hou je mond gezond' as part of which they fill out a questionaire on knowledge, attitude and locus of controls at the start of the lesson and at the end. The front dentition of the children will be photographed using a fluorescence camera (QLF), after which the test-group will receive explanation about the photograph and the control group will receive a standard message.
The photograph and questionnaire will be repeated after 4-6 weeks, when all children will get personalized oral hygiene advice according to their photo. |
|- Primary outcome||plaque percentage as derived from the photograhs|
|- Secondary outcome||knowledge, attitude and locus of controls as assessed by questionnaire.|
|- Timepoints||Both primary and secondary oucome measures are assessed at baseline and 8 weeks thereafter.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| M.H. Veen, van der|
|- CONTACT for SCIENTIFIC QUERIES|| M.H. Veen, van der|
|- Sponsor/Initiator ||ACTA-ADR|
(Source(s) of Monetary or Material Support)
|- Brief summary||Background of the study: |
Inadequate oral hygiene in children and adults is a common phenomenon. This may result in dental caries or periodontal disease, which are a major problem. The most important aspect in prevention is oral hygiene instruction where the importance of good oral health is emphasized. For this purpose the project "Hou je mond gezond" ('Keep your mouth healthy' , Ivoren Kruis) was developped, which is an educational program on oral health/ tooth brushing for children attending primary school. In this study we want to investigate if this classroom approach to improve oral hygiene and motivation can benefit from the addition of a fluorescence photograph diplaying the current oral hygiene status of each child. These so-called quantitative light-induced fluorescence (QLF) photographs show old plaque or calculus on the dentitition as red fluorescence. We hypothesize that showing these QLF-photos adjunct to the "Hou je mond gezond" lesson has a positive effect on oral hygiene behaviour and oral hygiene motivation in comparisson to the 'Hou je mond gezond' lesson alone.
Objective of the study:
In this study we want to investigate whether displaying QLF-pictures can help to improve oral hygiene behavior and motivation. We want to investigate the motivational effect of QLF-photos in children from groups 7 and 8 of primary schools, where the brushing instruction of "Hou je mond gezond" project (Ivoren Kruis) is used as reference. The research question of this study is, 'Does displaying fluorescence images of ones own dentitition have a positive impact in motivating participants to improve their oral hygiene?'.
The study will be carried out as a randomized controlled trial (RCT) linked to a 'Hou je mond gezond' lesson.
One half of the participating children will get to see the QLF photo of their dentition, which will be explained and linked to oral hygiene advice at both visits. The other half of children will get to see their QLF photo with eplanation and personal oral hygiene advice only at visit two, i.e the end of the study. All children are asked to fill out a brief questionaire on oral hygiene knowledge, behavior and motivation (1 A4) at the start and end of the oral hygiene lesson. The questionaire is repeated at the second visit.
Children with an age of about 10-12 years attending group 7 or 8 of primary schools.
Intervention (if applicable):
Primary study parameters/outcome of the study:
Primary study parameter: Plaque percentage assessed on fluorescence photos.
Secundary study parameters/outcome of the study (if applicable):
Motivation and knowledge measured through questionnaires.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness (if applicable):
Participation is only a very small burden on participating children: making and explaining the QLF photo takes up to one minute per child per visit (2 visits), next to the "Hou je mond gezond' lesson in the classroom wich is given to all children. Completing the questionnaire takes less than 5 minutes at a time. Given the nature of the study, we expect that all children benefit from the brushing lesson. There are no risks associated with participation.
|- Main changes (audit trail)|
|- RECORD||14-okt-2013 - 23-dec-2013|