UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060992 |
|---|---|
| Receipt number | R000069793 |
| Scientific Title | Morphological, radiological, and histological comparison of alveolar ridge preservation using two types of bone substitute |
| Date of disclosure of the study information | 2026/03/20 |
| Last modified on | 2026/03/19 15:19:16 |
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Basic information
Public title
Morphological, radiological, and histological comparison of alveolar ridge preservation using two types of bone substitute
Acronym
Morphological, radiological, and histological comparison of alveolar ridge preservation using two types of bone substitute
Scientific Title
Morphological, radiological, and histological comparison of alveolar ridge preservation using two types of bone substitute
Scientific Title:Acronym
Morphological, radiological, and histological comparison of alveolar ridge preservation using two types of bone substitute
Region
| Japan |
Condition
Condition
molar tooth loss
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Alveolar ridge preservation (ARP) is performed to prevent alveolar ridge resorption following the extraction of molars. Two types of bone grafting materials are used for ARP, and their efficacy is compared and evaluated morphologically, radiographically, and histologically.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Vertical bone formation on CBCT images 3 months after ARP
Key secondary outcomes
Bone formation volume (volume percentage relative to the extraction socket) on CBCT images 3 months after ARP
Buccal bone height on CBCT images 3 months after ARP
Changes in alveolar ridge volume captured using intra oral scanner 3 months after ARP
Histological comparison of bone formation at the time of implant placement
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
hydroxyapatite/collagen composite material
Interventions/Control_2
octacalcium/collagen composite material
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
Patients aged 20 years or olde but under 90 years at the time of consent acquisition
Patients seeking implant treatment in the molar region
Patients who require tooth extraction at the relevant site and need ARP to prevent bone resorption
The difference in alveolar bone height between buccal and lingual or palatal sides is within 5 mm
Patients who have provided written consent to participate in the study
Key exclusion criteria
Patients with acute inflammation at the treatment site
Smokers (10 or more cigarettes per day)
Pregnant patient
Patients with a history of allergy to collagen
Patients with uncontrolled metabolic disorders (diabetes, osteomalacia, thyroid disease, severe liver or kidney disease)
Patients who are taking long term steroid or immunosuppressive drugs for autoimmune diseases, etc
Patients taking antiresorptive agents
Patients undergoing radiation therapy
Other patients who are not adequate to participate this study
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Tetsurou |
| Middle name | |
| Last name | Odatsu |
Organization
Nagasaki University
Division name
Department of Applied Prosthodontics
Zip code
852-8588
Address
1-7-1, Sakamoto, Nagasaki
TEL
095-819-7688
odatsu@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Tetsurou |
| Middle name | |
| Last name | Odatsu |
Organization
Naasaki University
Division name
Department of Applied Prosthodontics
Zip code
852-8588
Address
1-7-1, Sakamoto, Nagasaki
TEL
095-819-7688
Homepage URL
odatsu@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Tetsurou Odatsu
Funding Source
Organization
Nagasaki University
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
Ethic committee of the Graduate School of Biomedical Sciences, Nagasaki University
Address
1-12-4, Sakamoto, Nagasaki
Tel
095-819-7198
gakujutu_gakuji@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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 02 | Month | 10 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 16 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 19 | Day |
Last follow-up date
| 2029 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 03 | Month | 19 | Day |
Last modified on
| 2026 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069793
