Condition category
Oral Health
Date applied
30/05/2016
Date assigned
31/05/2016
Last edited
01/06/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Public

Primary contact

Prof Annette Wiegand

ORCID ID

Contact details

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

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

Sponsor information

Organisation

University of Göttingen (Germany)

Sponsor details

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

Sponsor type

University/education

Website

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

Publication citations

Additional files

Editorial Notes