Pilot study on the use of a serious game in oral prophylaxis in children
Organizational Data
- DRKS-ID:
- DRKS00009698
- Recruitment Status:
- Recruiting planned
- Date of registration in DRKS:
- 2016-01-27
- Last update in DRKS:
- 2018-02-08
- Registration type:
- Prospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
Brief summary in lay language
No Entry
Brief summary in scientific language
Aim of the pilot study is to evaluate the effect of a dental serious game on school children (8-11 years) by semi-structured interviews. Questions are related to knowledge, attitudes and feelings about oral hygiene and the played computer game. The results will be compared to a group of school children playing a serious game without dental content.
Health condition or problem studied
- ICD10:
- K02.9 - Dental caries, unspecified
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Schoolchildren playing a dental serious game.
- Arm 2:
- Schoolchildren playing a game without dental content.
Endpoints
- Primary outcome:
- Aim of the study is a comparative analysis of semi-structured interviews of schoolchildren after playing a dental serious game. Primary outcomes are interview elements regarding oral hygiene knowledge.
- Secondary outcome:
- Secondary outcomes are elements regarding self-efficacy and game spirit.
Study Design
- Purpose:
- Prevention
- Allocation:
- Randomized controlled study
- Control:
-
- Placebo
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting planned
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- Other Grundschulen Freiburg im Breisgau
Recruitment period and number of participants
- Planned study start date:
- 2016-02-26
- Actual study start date:
- No Entry
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 30
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 8 Years
- Maximum Age:
- 11 Years
- Additional Inclusion Criteria:
- Informed consent of the parents and the head of school.
Exclusion Criteria
neurological disorders, disturbing behaviour, participation in other studies
Addresses
Primary Sponsor
- Address:
- Abteilung für Zahnerhaltungskunde & Parodontologie, Universitätsklinikum FreiburgDr. Johan WölberHugstetter Str. 5579106 FreiburgGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Uniklinik Freiburg, Abteilung für Zahnerhaltungskunde und ParodontologieDr. Johan WölberHusgtetter Str. 5579106 FreiburgGermany
- Telephone:
- 0049 761 270 47310
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Uniklinik Freiburg, Abteilung für Zahnerhaltungskunde und ParodontologieDr. Johan WölberHusgtetter Str. 5579106 FreiburgGermany
- Telephone:
- 0049 761 270 47310
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Uniklinik Freiburg, Abteilung für Zahnerhaltungskunde und ParodontologieDr. Johan WölberHusgtetter Str. 5579106 FreiburgGermany
- Telephone:
- 0049 761 270 47310
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Abteilung für Zahnerhaltungskunde & Parodontologie, Universitätsklinikum FreiburgHugstetter Str. 5579106 FreiburgGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Albert-Ludwigs-Universität FreiburgEngelberger Str. 2179106 FreiburgGermany
- Telephone:
- +49-761-27072600
- Fax:
- +49-761-27072630
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2015-07-14
- Ethics committee number:
- 320/15
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2015-11-09
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No Entry
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry