UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027253 |
|---|---|
| Receipt number | 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 00:05:24 |
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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
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
makikonishi@hotmail.com
Sponsor or person
Institute
University College Cork
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031220
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