UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Electronic-based personalised dental education for caries prevention in a disadvantaged population: a randomised controlled study
Title of the study (Brief title)	Electronic-based personalised dental education for caries prevention
Region	Europe

Condition
Condition	Dental caries
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This project aims to investigate the effectiveness of an electronic-based assessment (Cariogram) and a personalised approach to caries prevention.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	"Chance to avoid new cavities" of the Cariogram at six months after the baseline examination.
Key secondary outcomes	Frequency of fermentable-carbohydrate intake Amount of plaque present Bacterial counts (mutans streptococci, lactobacilli) Use of fluorides Salivary flow Salivary buffering capacity The knowledge, behaviour and patient satisfaction relating to personalised caries prevention at six months after the baseline examination.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom Other
Interventions/Control_1	Intervention A report of their caries risk assessment, along with their output chart as generated by Cariogram was sent by post to the subjects in the Test group. Once weekly for 24 weeks, the Test group received personalised oral health text messages on caries prevention.
Interventions/Control_2	Control The subjects in the Control group was sent only general information (not generated by Cariogram) on caries prevention, also by post. Once weekly for 24 weeks, while the Control group received non-personalised text messages offering general oral healthcare advice.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	19 years-old <=
Age-upper limit	70 years-old >=
Gender	Male and Female
Key inclusion criteria	(i) Willingness to participate in the project (ii) 19 to 70 years of age (iii) Medical card holder (used as a proxy for economic disadvantage) (iv) >=20 teeth present (v) Being not pregnant (vi) Being able to use text messaging
Key exclusion criteria	(i) Not willingness to participate in the project (ii) <19 years of age (iii) >70 years of age (iv) Non medical-card holder (v) <20 teeth present (vi) Being pregnant (vii) Being unable to use text messaging
Target sample size	200

Research contact person
Name of lead principal investigator	Professor Finbarr Allen
Organization	University Dental School & Hospital, University College Cork The National University of Singapore and Director of the NUHS Centre for Oral Health (since April 2016)
Division name	Restorative Dentistry. Faculty of Dentistry (since April 2016)
Address	Wilton, Cork city, Co. Cork, T12 E8YV, Republic of Ireland. 11 Lower Kent Ridge Road, 119083, Republic of Singapore (since April 2016)
TEL	+65-6772-5340
Email	f.allen@ucc.ie

Public contact
Name of contact person	Dr Makiko Nishi
Organization	University College Cork
Division name	Oral Health Services Research Centre
Address	Wilton, Cork city, Co. Cork, T12 E8YV, Republic of Ireland
TEL	+353-21-490-1210
Homepage URL
Email	makikonishi@hotmail.com

Sponsor
Institute	University College Cork
Institute
Department

Funding Source
Organization	The International Association for Dental Research (IADR)
Organization
Division
Category of Funding Organization	Outside Japan
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)	Unilever Ivoclar Vivadent

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions

Institutions

Oral Health Services Research Centre (Cork city, Co. Cork) Iona Dental Surgery (Cork city, Co. Cork) Frank Whelton Dental Surgery (Cork city, Co. Cork) Cork Dental Care (Cork city, Co. Cork) Tom McCarthy Dental Surgery (Macroom Town, Co. Cork) Elmwood Dental & Facial Aesthetics (Cork city, Co. Cork) Riverside Dental Care (Cork city, Co. Cork) Lydendental (Cork city, Co. Cork) William Street Dental Practice (Bantry Town, Co. Cork)

Other administrative information
Date of disclosure of the study information	2017 Year 05 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 07 Month 15 Day
Anticipated trial start date	2015 Year 02 Month 25 Day
Last follow-up date	2016 Year 06 Month 16 Day
Date of closure to data entry	2016 Year 08 Month 18 Day
Date trial data considered complete	2016 Year 08 Month 19 Day
Date analysis concluded	2017 Year 09 Month 30 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 05 Month 06 Day
Last modified on	2017 Year 05 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031220