UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042455 |
|---|---|
| Receipt number | R000048464 |
| Scientific Title | Effect of saliva on dental cement |
| Date of disclosure of the study information | 2020/11/14 |
| Last modified on | 2022/11/16 10:13:16 |
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Basic information
Public title
Effect of saliva on dental cement
Acronym
Effect of saliva on dental cement
Scientific Title
Effect of saliva on dental cement
Scientific Title:Acronym
Effect of saliva on dental cement
Region
| Japan |
Condition
Condition
1)Healthy volunteers
2)caries/periodontal disease/
pericoronitis
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate the extent to which saliva is immersed during the filling of dental cement
Basic objectives2
Others
Basic objectives -Others
Evaluation of material
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Vickers hardness/Immersion distance/Acoustic impedance/Gap distance
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
saliva
Those who do not have a disease that affects saliva production
Extracted tooth
Caries: Teeth judged to be difficult to preserve in C3 to C4
Periodontitis: Teeth judged to be difficult to preserve due to severe periodontitis (P3, etc.)
Pericoronitis: Teeth judged to be suitable for tooth extraction due to repeated pain / swelling
Key exclusion criteria
1) Saliva
Those suffering from diseases that affect saliva production
2) Extracted teeth
When the patient or the patient's family refuses to provide the extracted tooth
A tooth that was removed because the dentin was so severely damaged that it was not possible to secure the 3.5 mm x 3.5 mm x 1.5 mm that was to be formed into the tooth cavity
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Takahashi |
Organization
Tohoku University Hospital
Division name
Clinics of Dentistry for Disabled
Zip code
980-8575
Address
4-1, Seiryo-cho, Aoba-ku, Sendai City, Miyagi Prefecture
TEL
022-717-8438
at@dent.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Yukihiro |
| Middle name | |
| Last name | Naganuma |
Organization
Tohoku University Hospital
Division name
Clinics of Dentistry for Disabled
Zip code
980-8575
Address
4-1, Seiryo-cho, Aoba-ku, Sendai City, Miyagi Prefecture
TEL
022-717-8438
Homepage URL
dd169306@dent.tohoku.ac.jp
Sponsor or person
Institute
Clinics of Dentistry for Disabled, Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of education
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku University ethics committee
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
Tel
022-728-4105
med-kenkyo@grp.tohoku.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 11 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
5
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
Main results already published
Date of protocol fixation
| 2020 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Fill with cement that has been hardened by exposure to saliva and evaluate its physical properties.
Management information
Registered date
| 2020 | Year | 11 | Month | 14 | Day |
Last modified on
| 2022 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048464
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
