UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030340 |
|---|---|
| Receipt number | R000034648 |
| Scientific Title | Evaluating the transition of bacterial composition around dental implants over time |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2024/12/16 12:13:40 |
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Basic information
Public title
Evaluating the transition of bacterial composition around dental implants over time
Acronym
Transition of bacterial status around dental implants
Scientific Title
Evaluating the transition of bacterial composition around dental implants over time
Scientific Title:Acronym
Transition of bacterial status around dental implants
Region
| Japan |
Condition
Condition
Missing teeth
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the transition of bacterial composition around dental implants which are placed into patients by submerged insertion and to clarify the factors contributing to such changes.
Basic objectives2
Others
Basic objectives -Others
Unraveling the transition of bacterial composition
Associated factor
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bacterial composition
Key secondary outcomes
Inflammation of the gums
Plaque
Radiographic assessment
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Subjects with an indication for dental implant treatment who consent to the operation (both maxilla and mandible can be included).
2)Subjects with a first-person voluntary consent to participate in this clinical study, which can be obtained in writing (inpatients, outpatients, or both gender can be included).
3)Subjects aged 20 and above, at the time of a written consent.
Key exclusion criteria
1)The exclusion criteria for study device.
(1)Patients with hemorrhagic diathesis.
(2)Patients with metabolic or endocrine diseases that may significantly affect postoperative bone formation (severe osteoporosis and others).
(3)Patients taking steroids that may affect the postoperative healing of tissues.
(4)Patients with uncontrolled diabetes.
(5)Patients with strong bruxism or in overloading condition.
(6)Patients known to be allergic to the metal (titanium alloy) used in this product.
(7)Patients with a history of radiotherapy at the site of implantation.
(8)Patients for whom postoperative care cannot be controlled such as the following:
- Patients with dementia or other mental disabilities
- Patients with drug addiction
- Patients with alcoholism
(9)Patients with insufficient width and height of bone (bone mass) around the implant (patients who need combination therapy of bone prosthetic materials).
(10)Patients with serious cardiovascular disease such as myocardial infarction.
(11)Pregnant or breast-feeding patients.
(12)Other patients who are not adequate to participate this study.
*Additionally, the exclusion criteria for clinical study.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Shimogisji |
Organization
Graduate School of Medical and Dental Sciences, Institute of Science Tokyo
Division name
Regenerative and Reconstructive Medicine
Zip code
113-8519
Address
1-5-45, Yushima, Bunkyo-ku, TOKYO , JAPAN
TEL
03-5803-5773
shimogishi.irm@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Shimogishi |
Organization
Graduate School of Medical and Dental Sciences, Institute of Science Tokyo
Division name
Regenerative and Reconstructive Medicine
Zip code
113-8519
Address
1-5-45, Yushima, Bunkyo-ku, TOKYO , JAPAN
TEL
03-5803-5773
Homepage URL
shimogishi.irm@tmd.ac.jp
Sponsor or person
Institute
Graduate School of Medical and Dental Sciences, Institute of Science Tokyo
Regenerative and Reconstructive Medicine
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
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of Tokyo Medical and Dental University
Address
1-5-45, Yushima, Bunkyo-ku, TOKYO , 113-8549, JAPAN
Tel
03-5803-5404
d-hyoka.adm@tmd.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
| 2018 | Year | 04 | 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
24
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
| 2017 | Year | 12 | Month | 12 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 14 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To evaluate the transition of bacterial composition around dental implants and to clarify the factors contributing to such changes.
Management information
Registered date
| 2017 | Year | 12 | Month | 11 | Day |
Last modified on
| 2024 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034648
