UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052547 |
|---|---|
| Receipt number | R000059957 |
| Scientific Title | Comparative study of apatite carbonate and octacalcium phosphate in sinus lifts |
| Date of disclosure of the study information | 2023/10/21 |
| Last modified on | 2024/02/17 09:14:14 |
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Basic information
Public title
Comparative study of apatite carbonate and octacalcium phosphate in sinus lifts
Acronym
Comparative study of apatite carbonate and octacalcium phosphate
Scientific Title
Comparative study of apatite carbonate and octacalcium phosphate in sinus lifts
Scientific Title:Acronym
Comparative study of apatite carbonate and octacalcium phosphate
Region
| Japan |
Condition
Condition
missing tooth
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to compare the preoperative and postoperative volume changes of sinus lifts of apatite carbonate and octacalcium phosphate.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Volume immediately after sinus lift and 6 months after operation.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients requiring sinus lifts
Key exclusion criteria
Patients who do not consent to the research
Patients with systemic diseases
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Koudai |
| Middle name | |
| Last name | Nagata |
Organization
Kanagawa Dental University
Division name
Department of Oral and Maxillofacial Implantology
Zip code
238-8580
Address
82 Inaoka-cho, Yokosuka 238-8580, Japan
TEL
0468228880
ngata@kdu.ac.jp
Public contact
Name of contact person
| 1st name | Koudai |
| Middle name | |
| Last name | Nagata |
Organization
Kanagawa Dental University
Division name
Department of Oral and Maxillofacial Implantology
Zip code
235-0023
Address
82 Inaoka-cho, Yokosuka 238-8580, Japan
TEL
0468228880
Homepage URL
nagata@kdu.ac.jp
Sponsor or person
Institute
Kanagawa Dental University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kanagawa Dental University
Address
82 Inaoka-cho, Yokosuka 238-8580, Japan
Tel
08012499914
nagata@kdu.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 | 10 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
50
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
Main results already published
Date of protocol fixation
| 2022 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Change in volume of apatite carbonate and octacalcium phosphate after sinus lift
Management information
Registered date
| 2023 | Year | 10 | Month | 19 | Day |
Last modified on
| 2024 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059957
