Condition category
Oral Health
Date applied
24/02/2020
Date assigned
25/02/2020
Last edited
25/02/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Tooth decay is one of the most prevalent diseases affecting children in Jordan. Previous studies have indicated that many do not brush their teeth regularly and frequently consume sugary snacks. Parents reported facing difficulties in establishing healthy routines at home.

Video-games have been successfully used to educate and motivate children on a variety of topics, including in health education. The researchers in this study, have previously developed an English-speaking oral-health-education video-game. Testing that game in a sample of children in London, United Kingdom has shown that the game can promote some positive changes on children's dietary knowledge and practices.

The researchers have now developed an Arabic-speaking oral-health-education video-game. The aim of this study is to evaluate this game and see if it teaches and encourages children to take care of their teeth.

Who can participate?
Children in 1st and 2nd school-grade (six- to eight-year-old) attending a public school in Amman, Jordan.

What does the study involve?
A group of public schools in Amman, Jordan, will be invited to take part in this study. Children in the 1st and 2nd grade in those schools will be targeted. The researchers will examine the children's teeth at baseline to evaluate how much dental plaque and tooth decay they have. The researchers will also give them questionnaires to be completed by them and their parents to give us an insight into their oral health habits. The children's will be asked to fill in a picture-based questionnaire that quizzes them on foods and drinks that contain sugar. They will also be asked to record their foods and drinks and toothbrushing for a few days. The parents’ will be asked about their basic demographics such as education and current employment in addition to their child’s toothbrushing habits, dietary habits, and visits to the dentist.

The researchers will then divide the schools into two groups, one group will get to play a simple video-game (Computer and smartphone) about taking care of their teeth (toothbrushing, healthy diet, visiting the dentist) at school and at home. The other group will not receive any intervention at this stage.

Three months after the intervention, the researchers will re-visit the schools to re-examine the children’s teeth and ask them and their parents to fill-in the questionnaires again to determine if the video-game has helped them take better care of their teeth.

Participation will be voluntary and no one will be forced to take part. Participants can choose not to answer any questions or withdraw from the study at any time without giving an explanation and without any impact on their care. The researchers will follow ethical and legal practice and all information will be handled in confidence and will remain anonymous throughout.

What are the possible benefits and risks of participating?
Children and families taking part in the study and allocated to the intervention group might benefit from the oral health advice provided by the oral health education video-game. Children and families from the control group will be given oral health advice verbally by the research team following the conclusion of the study. there are no foreseen risks to taking part in this study.

Where is the study run from?
The University of Jordan

When is the study starting and how long is it expected to run for?
December 2019 to May 2020

Who is funding the study?
The Borrow Foundation (UK)

Who is the main contact?
Dr Ahmad Aljafari (public)
ahmad.jafari@ju.edu.jo
Prof Marie Therese Hosey (scientific)
m.t.hosey@kcl.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Dr Ahmad Aljafari

ORCID ID

https://orcid.org/0000-0002-2292-3311

Contact details

Department of Paediatric Dentistry
Orthodontics
and Preventive Dentistry
School of Dentistry
The University of Jordan
Amman
11942
Jordan
+96265355000 ext (23557)
ahmad.jafari@ju.edu.jo

Type

Scientific

Additional contact

Prof Marie Therese Hosey

ORCID ID

https://orcid.org/0000-0003-1178-4106

Contact details

Division of Population and Patient Health
King's College London Dental Institute
London
SE5 9RS
United Kingdom
+44 (0)20 3299 9000
m.t.hosey@kcl.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

University of Jordan/Video-Game

Study information

Scientific title

Evaluation of an Arabic-speaking oral health education video-game for children aged six to eight years

Acronym

Study hypothesis

There are no statistically significant differences in children's oral health knowledge or practices following the use of an oral-health-education video-game when compared to a control group

Ethics approval

1. Approved 08/08/2019, Jordan University Hospital Institutional Review Board (JUH IRB, PO BOX 13046, 11942 Amman, Jorda; +962 6 5353388; m.ahram@ju.edu.jo), ref: 2019/176
2. Approved 25/09/2019, Jordanian Ministry of Health - School Health Division (PO BOX 86, 11118 Amman, Jordan; +962 6 5200230; diwan@moh.gov.jo), ref: 461/1122942
3. Approved 07/11/2019, Jordanian Ministry of Education - 61298/10/3 (PO BOX 1646, 11118 Amman, Jordan; +962 6 5607331; moecs@moe.gov.jo), ref: 2019/176

Study design

An interventional study (Randomised Controlled Trial). Public schools in Amman, Jordan will be randomly chosen and children aged six to eight in those schools will be assigned to one of two study groups:
1. Intervention group: receives an oral-health-education video-game.
2. Control group: receives no intervention (Blank).

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

Dental caries

Intervention

Cluster sampling will be used. A group of public schools in Amman, Jordan, will be selected randomly and invited to take part. Children in first and second grades in those schools will be targeted.

Schools that agree to take part will be randomly assigned to either the control or intervention group as follows:

Intervention group: plays an oral health education video-game at school and gets a link to download the game at home. The content of the game is based on the caries prevention recommendations of Public Health England's ‘Delivering Better Oral Health’ guidelines (Public Health England 2017). The game contains segments on non-cariogenic food selection, tooth brushing with fluoride toothpaste, and visiting the dentist regularly for fluoride application. The game is based on a previous, English-speaking, video-game that the research team had developed.
Control group: does not receive any intervention.

Follow up for both group will be for three months after the intervention.

Randomisation: Cluster randomisation will be used. A list of all primary public schools in Amman, Jordan fitting the study's criteria will be drawn. Six schools will be randomly selected using computer-generated numbers. The selected schools will then be randomly allocated to either intervention or control group using a simple computer-generated grid.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Children's dietary knowledge measured using a Pictorial Dietary Questionnaire (PDQ) at baseline and three months after the intervention

Secondary outcome measures

At baseline and three months after the intervention:
1. Dietary and tooth brushing practices, as reported by children: recorded using tooth brushing and diet diaries
2. Dietary, tooth brushing, and dental attendance practices, as reported by parents: recorded using the Child Dietary Questionnaire (CDQ) and the Oral Health Habits Questionnaire (OHHQ)
3. Children’s plaque scores: measured using the Oral Hygiene Index (OHI)

Overall trial start date

01/09/2019

Overall trial end date

31/05/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Children in 1st and 2nd school-grade (six- to eight-year-old)
2. Attending a public school in Amman, Jordan

Participant type

Other

Age group

Child

Gender

Both

Target number of participants

Number of schools (clusters): six. Number of children (participants) in each schools: 166. Total participants: 996

Participant exclusion criteria

Schools, children or parents that decline consent to participate

Recruitment start date

01/12/2019

Recruitment end date

31/05/2020

Locations

Countries of recruitment

Jordan

Trial participating centre

The University of Jordan
Queen Rania Street
Amman
11942
Jordan

Sponsor information

Organisation

University of Jordan

Sponsor details

Queen Rania Street
Amman
11942
Jordan
+962 65355000
dent.diwan@ju.edu.jo

Sponsor type

University/education

Website

http://www,ju,edu,jo

Organisation

King's College London

Sponsor details

Strand
London
WC2R 2LS
United Kingdom
+44 (0)2078365454
m.t.hosey@kcl.ac.uk

Sponsor type

University/education

Website

http://www.kcl.ac.uk/index.aspx

Funders

Funder type

Charity

Funder name

The Borrow Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

1. Study final report to funder (August 2020).
2. Publication of results in a peer-reviewed journal (September 2020)

IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date.

Intention to publish date

01/09/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

25/02/2020: Trial’s existence confirmed by The Borrow Foundation