UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055954 |
|---|---|
| Receipt number | R000063942 |
| Scientific Title | Examination of the optimal load-bearing start time for implants placed simultaneously with maxillary sinus floor elevation using the alveolar crest approach |
| Date of disclosure of the study information | 2024/10/25 |
| Last modified on | 2026/01/13 22:16:32 |
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Basic information
Public title
Examination of the optimal load-bearing start time for implants placed simultaneously with maxillary sinus floor elevation using the alveolar crest approach
Acronym
Examination of the optimal load-bearing start time for implants placed simultaneously with maxillary sinus floor elevation using the alveolar crest approach
Scientific Title
Examination of the optimal load-bearing start time for implants placed simultaneously with maxillary sinus floor elevation using the alveolar crest approach
Scientific Title:Acronym
Examination of the optimal load-bearing start time for implants placed simultaneously with maxillary sinus floor elevation using the alveolar crest approach
Region
| Japan |
Condition
Condition
tooth loss
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, the purpose of this study was to perform implant placement at the same time as maxillary sinus floor elevation using the alveolar crest approach, and to evaluate the timing of starting load bearing based on the ISQ value at that time.
Basic objectives2
Others
Basic objectives -Others
As a result of this research, by clarifying when to start weight-bearing, it is possible to present the flow of treatment to patients in a more concrete manner, and it may also be possible for medical professionals to decide the time to start weight-bearing with peace of mind.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Find out when ISQ>65
Key secondary outcomes
1) Image evaluation: amount of host bone, amount of created bone.
2) Torque value at the time of implantation.
3) ISQ: At the time of implantation, at each measurement, and at the time of final prosthesis placement.
4) Number of implants for which ISQ>65 could not be obtained by the period.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Patients whose vertical distance of the alveolar bone to the maxillary sinus at the planned implantation location is 3-7.5 mm according to CBCT, and it has been determined that maxillary sinus floor elevation using the alveolar crest approach is necessary for implant placement.
2. Age: Patients aged 20 to 90 years at the time of obtaining consent.
3. Patients who have received sufficient explanation to participate in this study, and who have given their own voluntary written consent based on sufficient understanding.
Key exclusion criteria
Patients who fall under any of the following will be excluded from the study.
1. Patients with severe blood disorders
2. Patients suspected of having abnormalities in calcium metabolism system organs such as kidneys or digestive organs or collagen disease
3. Patients who are considered difficult to visit for follow-up, such as those living in remote areas
4. Patients whose social or home environment restricts their ability to comply with the requirements of this study
5. Smoker
6. Patients who are pregnant or breastfeeding.
7. Patients who require a legal guardian
8. Patients receiving treatment with drugs that affect bone metabolism, such as bisphosphonates.
9. Other patients judged to be inappropriate by the research director or research co-investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yujiro |
| Middle name | |
| Last name | Furuse |
Organization
Arie Furuse Dental Oralsurgery Clininc
Division name
Director
Zip code
8592206
Address
Nakasukawa 202-1 Arie Minamishimabara Nagasaki
TEL
0957824182
yfuruse2@icloud.com
Public contact
Name of contact person
| 1st name | Yujiro |
| Middle name | |
| Last name | Furuse |
Organization
Arie Furuse Dental Oralsurgery Clininc
Division name
Director
Zip code
8592206
Address
Nakasukawa 202-1 Arie Minamishimabara Nagasaki
TEL
0957824182
Homepage URL
yfuruse2@icloud.com
Sponsor or person
Institute
Arie Furuse Dental Oralsurgery Clininc
Institute
Department
Personal name
Yujiro Furuse
Funding Source
Organization
Arie Furuse Dental Oralsurgery Clinic
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University Hospital Clinical Research Ethics Committee
Address
Sakamoto 1-7-1 Nagasaki-city Nagasaki
Tel
0958197229
kenkyujim-ngs@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
有家ふるせ歯科口腔外科クリニック（長崎県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 25 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 03 | Month | 23 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 23 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2026 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2027 | Year | 03 | Month | 31 | Day |
Other
Other related information
This study targets cases in which maxillary sinus floor elevation using an alveolar crest approach is used in combination with implant treatment for tooth-deficient areas. A healing abutment is attached to the implant so that it is flush with the gingiva, and the wound is closed. The ISQ value will be measured every 4 weeks after the completion of surgery to evaluate the state of implant fixation. Impressions are taken when ISQ > 65, and temporary teeth are fitted if necessary. The final prosthesis is then fitted. This time is the time to start applying the load. Measure ISQ again when wearing. In order to evaluate the relationship between changes in bone volume and ISQ values, ISQ measurements and CBCT imaging will be performed when ISQ > 65 and when the final prosthesis is installed.
Management information
Registered date
| 2024 | Year | 10 | Month | 25 | Day |
Last modified on
| 2026 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063942
