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 | 2023/11/20 11:56:56 |
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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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
50 patients using implants for upper and lower jaw crest defects
1) Any age and gender
2) Have 1 to 3 tooth defects in the oral cavity
3) Able to perform dental implant surgery and single crown prosthetics
4) Able to answer a self-administered questionnaire
Key exclusion criteria
1) Poorly controlled general condition
2) Chemotherapy for head and neck
3) Previous radiation therapy
4) Heavy smoker (>10 cigarettes/day)
5) Infectious diseases
6) Mental illness
7) TMJ disorder
For history of BP medication, follow the tooth extraction guideline and consult the primary physician.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Kanazawa |
Organization
Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Division name
Digital Dentistry
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, Tokyo Medical and Dental University
Division name
Digital Dentistry
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, Tokyo Medical and Dental University
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
Tokyo Medical and Dental University
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
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
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
Preinitiation
Date of protocol fixation
| 2023 | Year | 03 | Month | 01 | Day |
Date of IRB
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) Obtain consent for participation in the study after performing a screening examination on the participant.
2) CT imaging was performed and a dental implant placement plan was made using simulation software.
3) The surgeon wears an MR device and performs implant placement under local anesthesia.
4) After the implant placement is completed, the data tracked by the MR device is stored in a dedicated PC. The patient's postoperative CT scan is performed to verify the accuracy by superimposing the 3D data with the preoperative implantation plan.
5) Accumulate the tracking data with the MR device and evaluate the movement of the fingers and handpiece about the dentition.
Management information
Registered date
| 2023 | Year | 11 | Month | 20 | Day |
Last modified on
| 2023 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060306
