Differential learning and oral hygiene

ISRCTN	ISRCTN14951343
DOI	https://doi.org/10.1186/ISRCTN14951343
Secondary identifying numbers	13/1/16

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

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

Prof Annette Wiegand
Public

Department of Preventive Dentistry, Periodontology and Cariology
Robert-Koch-Str. 40
Göttingen
37075
Germany

Study information

Study design	Single-centre randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	School
Study type	Prevention
Participant information sheet	Not available in web format, please use contact details to request a 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	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 study start date	01/12/2015
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	Both
Target number of participants	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

University of Göttingen (Germany)

Department of Preventive Dentistry, Periodontology and Cariology
37075

Sponsor information

University of Göttingen (Germany)
University/education

Department of Preventive Dentistry, Periodontology and Cardiology
Robert-Koch-Str. 40
Göttingen
37075
Germany

"ROR"	https://ror.org/01y9bpm73

Funders

Funder type

Hospital/treatment centre

University Medical Center Göttingen (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
Publication and dissemination plan	To be confirmed at a later date
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2018		Yes	No

Editorial Notes

12/03/2018: Publication reference added.