UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052845 |
|---|---|
| Receipt number | R000060306 |
| Scientific Title | Development of database for dental implant surgery using MR devices and research on infrastructure for remote surgical support |
| Date of disclosure of the study information | 2023/11/20 |
| Last modified on | 2026/05/25 16:21:39 |
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Basic information
Public title
Development of database for dental implant surgery using MR devices and research on infrastructure for remote surgical support
Acronym
Development of database for dental implant surgery using MR devices and research on infrastructure for remote surgical support
Scientific Title
Development of database for dental implant surgery using MR devices and research on infrastructure for remote surgical support
Scientific Title:Acronym
Development of database for dental implant surgery using MR devices and research on infrastructure for remote surgical support
Region
| Japan |
Condition
Condition
Tooth, jawbone or maxillofacial defects caused by caries, periodontal disease, trauma, tumors, congenital defects, etc.
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will develop an algorithm for appropriate procedures in dental implant surgery using a trackable MR device, construct a database that enables data accumulation, and then clinically evaluate a new surgical support system using AR technology.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hand and handpiece movement relative to dentition
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
25 patients using implants for upper and lower jaw crest defects
1) Aged 20 years or older, regardless of gender
2) Scheduled to undergo dental implant surgery, with 1 to 3 missing teeth in the oral cavity
3) Confirmed to undergo dental implant surgery at the Institute of Science Tokyo
Key exclusion criteria
None specified
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Kanazawa |
Organization
Graduate School of Medical and Dental Sciences, Institute of Science Tokyo
Division name
Department of Gerodontology and Oral Rehabilitation
Zip code
1138549
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5379
m.kanazawa.gerd@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Manabu |
| Middle name | |
| Last name | Kanazawa |
Organization
Graduate School of Medical and Dental Sciences, Institute of Science Tokyo
Division name
Department of Gerodontology and Oral Rehabilitation
Zip code
1138549
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5379
Homepage URL
m.kanazawa.gerd@tmd.ac.jp
Sponsor or person
Institute
Graduate School of Medical and Dental Sciences, Institute of Science Tokyo
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institute of Science Tokyo
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo Japan
Tel
03-5803-5379
info.bec@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
東京科学大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 11 | Month | 20 | 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
25
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
Completed
Date of protocol fixation
| 2023 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 17 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1)Explain the details of the study to the participants and obtain their written informed consent.
2)The operator wears the MR device and performs the implant placement surgery using the conventional method.
3)Upon completion of the implant placement, save the data acquired by the MR device to a dedicated PC.
4)Along with accumulating the data obtained from the MR device, evaluate the movements of the hand and handpiece relative to the dentition.
Management information
Registered date
| 2023 | Year | 11 | Month | 20 | Day |
Last modified on
| 2026 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060306
