Differential learning and oral hygiene
| ISRCTN | ISRCTN14951343 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14951343 |
| Protocol serial number | 13/1/16 |
| Sponsor | University of Göttingen (Germany) |
| Funder | University Medical Center Göttingen (Germany) |
- Submission date
- 30/05/2016
- Registration date
- 31/05/2016
- Last edited
- 12/03/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
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
Contact information
Public
Department of Preventive Dentistry, Periodontology and Cariology
Robert-Koch-Str. 40
Göttingen
37075
Germany
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Effect of differential learning on the oral hygiene status of 6- to 9-year-old children |
| Study objectives | 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(s) | Ethics committee of the University Medical Center Göttingen, 24/02/2016, No:13/1/16 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
1. Quigley-Hein plaque index at day 21, 42 and 63 |
| Key secondary outcome measure(s) |
None |
| Completion date | 10/06/2016 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Child |
| Lower age limit | 6 Years |
| Upper age limit | 9 Years |
| Sex | All |
| Target sample size at registration | 50 |
| Key inclusion criteria | Healthy children aged 6 to 9 years |
| Key exclusion criteria | Toothpaste allergy |
| Date of first enrolment | 14/03/2016 |
| Date of final enrolment | 06/04/2016 |
Locations
Countries of recruitment
- Germany
Study participating centre
37075
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2018 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
12/03/2018: Publication reference added.
