UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040973 |
|---|---|
| Receipt number | 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 | 2024/07/04 21:33:51 |
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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
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
torisu@nagasaki-u.ac.jp
Sponsor or person
Institute
Department of Prosthetic Dentistry, Graduate School of Biomedical Sciences, Nagasaki University
Institute
Department
Personal name
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
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
https://center6.umin.ac.jp/cgi-bin/icdr/ctr_view_reg.cgi?recptno=R000046757
Publication of results
Partially published
Result
URL related to results and publications
https://jorofacialpain.sakura.ne.jp/?page_id=1487
Number of participants that the trial has enrolled
77
Results
The difference between expected pain before the dental implant surgery and pain that the patients actually felt by the surgery (pain after surgery) was examined. The value of visual analogue scale (VAS) of the expected pain was significantly larger than the pain after surgery. Additionally, it is suggested that the increasing tendency becomes strong in the patients who showed high value in pain catastrophizing scale.
Results date posted
| 2024 | Year | 07 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The patients who received dental implant surgery
Participant flow
obtainment of informed consent, preoperative evaluation, postoperative evaluation
Adverse events
non
Outcome measures
Visual analog scale (VAS) of pain intensity before and after implant surgery
pain catastrophizing scale
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
| 2024 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046757
