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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027253
Receipt No. R000031220
Scientific Title Electronic-based personalised dental education for caries prevention in a disadvantaged population: a randomised controlled study
Date of disclosure of the study information 2017/05/10
Last modified on 2017/05/06

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Basic information
Public title Electronic-based personalised dental education for caries prevention in a disadvantaged population: a randomised controlled study
Acronym Electronic-based personalised dental education for caries prevention
Scientific Title Electronic-based personalised dental education for caries prevention in a disadvantaged population: a randomised controlled study
Scientific Title:Acronym 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
1st name
Middle name
Last name 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)
Zip code
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
1st name
Middle name
Last name Dr Makiko Nishi
Organization University College Cork
Division name Oral Health Services Research Centre
Zip code
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

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 07 Month 15 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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