UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041862 |
|---|---|
| Receipt number | R000047789 |
| Scientific Title | Building a safe and secure dental care environment using PHR managed by the patient himself: A pilot study |
| Date of disclosure of the study information | 2021/12/28 |
| Last modified on | 2021/10/19 14:18:09 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Building a safe and secure dental care environment using PHR managed by the patient himself
Acronym
PHR Dentistry
Scientific Title
Building a safe and secure dental care environment using PHR managed by the patient himself: A pilot study
Scientific Title:Acronym
PHR-DP
Region
| Japan |
Condition
Condition
Dental caries, Endodontic lesioin, Periodontitis
Classification by specialty
| Dental medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to transform the materials used for explanations provided b dental institutions to patients to personal health information managed by patients themselves, from treating personal health records (PHR) as medical information, and change their behavior toward dental care after 6 months after use.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Behavior change of the patient
Key secondary outcomes
Changes in oral examination values, changes in the perception of dental care providers
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Explanation for the inspection (including dentition), imaging tests (X-rays and intraoral photographs), periodontal tissue tests, and documents issued for dental disease management, etc., which patients receive explanations at the time of dental consultation will be imported to a secure smartphone, etc. When necessary, it can be reviewed by oneself to correct the behavior, and presented or provided to the newly visited medical institution.
Interventions/Control_2
Explanation for the inspection (including dentition), imaging tests (X-rays and intraoral photographs), periodontal tissue tests, and documents issued for dental disease management, etc., which patients receive explanations at the time of dental consultation will be given to the patient as usual consultation.
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. First-visit patients who visit each university hospital between June 30, 2021 after approval by the Ethics Committee
2. Patients who can obtain written consent to participate in the research voluntarily
3. Outpatients in a clinical department specializing in dental conservative treatment
Key exclusion criteria
Women who are pregnant or may become pregnant at the first visit
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Shogo |
| Middle name | |
| Last name | Takahsiba |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Pathophysiology - Periodontal Science
Zip code
700-8525
Address
2-5-1 Shikata-cho, Kita-ku, Okayama 700-8525, Japan
TEL
086-235-6677
stakashi@okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Shogo |
| Middle name | |
| Last name | Takahsiba |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Pathophysiology - Periodontal Science
Zip code
700-8525
Address
2-5-1 Shikata-cho, Kita-ku, Okayama 700-8525, Japan
TEL
086-235-6677
Homepage URL
stakashi@okayama-u.ac.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
Japanese Association for Dental Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Tokyo Medical and Dental University
Tohoku University
Ohu University
Meikai University
Tsurumi University
Aichi Gakuin University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address
2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
Tel
086-235-6938
mae6605@adm.okayama-u.ac.jp
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
岡山大学病院（岡山県），東北大学病院（宮城県），奥羽大学歯学部附属病院（福島県），明海大学歯学部付属明海大学病院（埼玉県），鶴見大学歯学部附属病院（神奈川県），愛知学院大学歯学部附属病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 12 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 09 | Month | 23 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 26 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 28 | Day |
Date of closure to data entry
| 2022 | Year | 01 | Month | 10 | Day |
Date trial data considered complete
| 2022 | Year | 01 | Month | 20 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 09 | Month | 22 | Day |
Last modified on
| 2021 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047789
