Plain English Summary
Background and study aims
Toothbrushing to remove dental biofilm (bacteria) is important to prevent oral diseases. Accurate brushing techniques are necessary to improve biofilm removal compared to habitual toothbrushing, but are difficult to adopt. This study aims to analyse the effect of differential learning on the adoption of a toothbrushing technique.
Who can participate?
Healthy children aged 6 to 9
What does the study involve?
Participants are randomly allocated to three groups. The intervention lasts for 15 days, and all children receive the same toothbrush and toothpaste during the whole study. In the control group, the children are asked to brush their teeth with their habitual brushing technique. In the second group, the brushing technique is instructed once a day by verbal instruction and demonstration models. In the third group, the brushing technqiue is instructed once a day according to the differential learning approach (one variation per day, 15 variations in total). Oral hygiene is assessed before the intervention and 21 days, 42 days and 63 day after the beginning of the intervention.
What are the possible benefits/risks of participating?
The participants might improve their personal oral hygiene. No side effects are expected.
Where is the study run from?
Department of Preventive Dentistry, Periodontology and Cariology, University Medical Center Göttingen (Germany)
When is study starting and how long is it expected to run for?
December 2015 to June 2016
Who is funding the study?
Department of Preventive Dentistry, Periodontology and Cariology, University Medical Center Göttingen (Germany)
Who is the main contact?
Prof. Dr Annette Wiegand
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
13/1/16
Study information
Scientific title
Effect of differential learning on the oral hygiene status of 6- to 9-year-old children
Acronym
Study hypothesis
The null hypothesis is that there is no significant difference in the oral hygiene status (Quigley-Hein plaque-index and papilla bleeding index) of children brushing:
1. With the habitual technique
2. After instruction of a brushing technique
3. After instruction of a brushing technique with the differential learning approach
at 21, 42 and 63 days after the start of the study.
Ethics approval
Ethic committee of the University Medical Center Göttingen, 24/02/2016, No:13/1/16
Study design
Single-centre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Schools
Trial type
Prevention
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Oral hygiene
Intervention
This single-center study is conducted by the Department of Preventive Dentistry, Periodontology and Cariology at the Primary School Drispenstedt, 32235 Hildesheim, Germany. Approximately fifty children are randomly allocated to three groups:
1. Control: No treatment, habitual toothbrushing with standardized toothbrush and toothpaste
2. Instruction of brushing technique: Toothbrushing technique is instructed, toothbrushing is performed with standardized toothbrush and toothpaste
3. Instruction of brushing technique and differential learning: Toothbrushing technique is instructed, toothbrushing is performed with standardized toothbrush and toothpaste while applying differential learning
Intervention type
Behavioural
Phase
Drug names
Primary outcome measures
1. Quigley-Hein plaque index at day 21, 42 and 63
2. Papilla bleeding index at day 21, 42 and 63
Secondary outcome measures
None
Overall trial start date
01/12/2015
Overall trial end date
10/06/2016
Reason abandoned
Eligibility
Participant inclusion criteria
Healthy children aged 6 to 9 years
Participant type
Healthy volunteer
Age group
Child
Gender
Both
Target number of participants
50
Participant exclusion criteria
Toothpaste allergy
Recruitment start date
14/03/2016
Recruitment end date
06/04/2016
Locations
Countries of recruitment
Germany
Trial participating centre
University of Göttingen (Germany)
Department of Preventive Dentistry, Periodontology and Cariology
37075
Funders
Funder type
Not defined
Funder name
University Medical Center Göttingen (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
To be confirmed at a later date
Intention to publish date
Participant level data
Not expected to be available
Results - basic reporting
Publication summary