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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000040973
Receipt No. R000046757
Scientific Title Subjective quantitative and qualitative measurements of pain before and after implant surgery
Date of disclosure of the study information 2020/07/01
Last modified on 2020/07/01

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Basic information
Public title Subjective quantitative and qualitative measurements of pain before and after implant surgery
Acronym Subjective measurements of pain before and after implant surgery
Scientific Title Subjective quantitative and qualitative measurements of pain before and after implant surgery
Scientific Title:Acronym Subjective measurements of pain before and after implant surgery
Region
Japan

Condition
Condition Masticatory dysfunction caused by tooth missing
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine pain before and after implant surgery
Basic objectives2 Others
Basic objectives -Others To examine the relationship between pain intensity and catastrophic thinking before and after implant surgery
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Visual analog scale (VAS) of pain intensity before and after implant surgery
Key secondary outcomes Profile of Mood States (POMS): short version

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
20 years-old <=
Age-upper limit
85 years-old >
Gender Male and Female
Key inclusion criteria Patients who choose dental implant treatment
Key exclusion criteria The person who does not give informed consent, the person who uses psychotropic drug, the person with experience of pain within two months, the person who can not understand the meaning of the questions, the person with chronic pain
Target sample size 65

Research contact person
Name of lead principal investigator
1st name Tetsurou
Middle name
Last name Torisu
Organization Nagasaki University
Division name Department of Prosthetic Dentistry, Graduate School of Biomedical Sciences
Zip code 8528588
Address 1-7-1 Sakamoto, Nagasaki
TEL 0958197692
Email torisu@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name Tetsurou
Middle name
Last name Torisu
Organization Nagasaki University
Division name Department of Prosthetic Dentistry, Graduate School of Biomedical Sciences
Zip code 8528588
Address 1-7-1 Sakamoto, Nagasaki
TEL 0958197692
Homepage URL
Email torisu@nagasaki-u.ac.jp

Sponsor
Institute Department of Prosthetic Dentistry, Graduate School of Biomedical Sciences, Nagasaki University
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Nakai Dental Office
Name of secondary funder(s)

IRB Contact (For public release)
Organization the ethics committee of Nagasaki University Graduate School of Medicine and Dentistry
Address 1-7-1, Sakamoto, Nagasaki
Tel 0958197229
Email gaibushikin@ml.nagasaki-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 なかい歯科(京都府)/Nakai Dental Office (Kyoto)

Other administrative information
Date of disclosure of the study information
2020 Year 07 Month 01 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 59
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
2014 Year 07 Month 28 Day
Date of IRB
2014 Year 09 Month 08 Day
Anticipated trial start date
2014 Year 09 Month 09 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To examine the effect of the degree of catastrophic thinking on quality and/or intensity of pain before and after implant surgery by use of pain VAS and Profile of Mood Status (POMS)

Management information
Registered date
2020 Year 07 Month 01 Day
Last modified on
2020 Year 07 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046757

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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