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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000042455
Receipt No. R000048464
Scientific Title Effect of saliva on dental cement
Date of disclosure of the study information 2020/11/14
Last modified on 2020/11/14

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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
Email 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
Email dd169306@dent.tohoku.ac.jp

Sponsor
Institute Clinics of Dentistry for Disabled, Tohoku University Hospital
Institute
Department

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
Email 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 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 Open public recruiting
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 06 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
2020 Year 11 Month 14 Day


Link to view the page
URL(English) https://upload.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


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