UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059637 |
|---|---|
| Receipt number | R000068214 |
| Scientific Title | Clinical and histological analysis of socket preservation using octacalcium phosphate collagen (OCP/Col) |
| Date of disclosure of the study information | 2025/11/05 |
| Last modified on | 2025/11/04 18:03:47 |
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Basic information
Public title
Radiological and histological analysis of alveolar ridge preservation using octacalcium phosphate collagen composite(OCP/Col)
Acronym
Radiological and histological analysis of alveolar ridge preservation using octacalcium phosphate collagen composite(OCP/Col)
Scientific Title
Clinical and histological analysis of socket preservation using octacalcium phosphate collagen (OCP/Col)
Scientific Title:Acronym
Clinical and histological analysis of socket preservation using octacalcium phosphate collagen (OCP/Col)
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 evaluate the bone regeneration capability of Octacalcium Phosphate Collagen Composites (OCP/Col) when used alone for ridge preservation procedures (ARP), from radiographic and histological perspectives.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Radiographic and histological evaluation of tissue regeneration after the use of Octacalcium Phosphate Collagen Composites (OCP/Col) for ridge preservation procedures (ARP)
Key secondary outcomes
Radiographic and histological evaluation of tissue regeneration after the use of Octacalcium Phosphate Collagen Composites (OCP/Col) for ridge preservation procedures (ARP) by tooth type
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine | Other |
Interventions/Control_1
In patients scheduled for ridge preservation (ARP) at the time of extraction with implant therapy planned, the molar group(OCP-M group) using Octacalcium Phosphate Collagen (OCP/Col) was designated (OCP-M group).
Interventions/Control_2
In patients scheduled for ridge preservation (ARP) at the time of extraction with implant therapy planned, the anterior teeth and premolar group (OCP-IP group) using Octacalcium Phosphate Collagen (OCP/Col) was designated.
Interventions/Control_3
In patients scheduled for ridge preservation (ARP) at the time of extraction with implant therapy planned, the molar group using athero-collagen (Control-M group) was designated.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The subjects of this study were patients aged 18 years or older who required extraction in the maxilla or mandible and had planned implant-supported prosthetic treatment.
Key exclusion criteria
Exclusion criteria
The following were excluded from the study:
Patients for whom participation was judged inappropriate due to systemic diseases (e.g., poorly controlled diabetes with HbA1c > 7)
Patients currently using or with a history of bisphosphonate preparations or denosumab
Patients with neurocognitive disorders
Smokers
Patients on steroids
Patients using immunosuppressants
Patients with liver dysfunction or kidney dysfunction
Patients undergoing chemotherapy or radiotherapy, or with a history of head and neck radiotherapy
Pregnant or breastfeeding women
Patients who did not wish to participate in this study
Patients who withdrew consent to participate
Patients in whom histological examination could not be performed due to anatomical requirements, etc.
Patients with alveolar bone damage caused by tooth extraction procedures
Patients in whom the specimen for bone biopsy was damaged or its orientation was unclear, making analysis impossible
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Takashita |
Organization
Medical Corporation Jinyu-kai Takeshita Dental Clinic
Division name
Medical Corporation Jinyu-kai Takeshita Dental Clinic
Zip code
177-0035
Address
3-1-12 Minami-Tanaka, Nerima-ku, Tokyo, Japan
TEL
0339044138
k.t@shika-takeshita.com
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Miyazawa |
Organization
Medical Corporation Jinyu-kai Takeshita Dental Clinic
Division name
Medical Corporation Jinyu-kai Takeshita Dental Clinic
Zip code
177-0035
Address
3-1-12 Minami-Tanaka, Nerima-ku, Tokyo, Japan
TEL
0339044138
Homepage URL
jin.tmiyazawa@gmail.com
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Medical Corporation Jinyu-kai Takeshita Dental Clinic
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
Japanese Society of Oral Implantology
Address
8F, First Okada Building, 4-3-5 Shiba, Minato-ku, Tokyo, Japan
Tel
0357655516
jsoi@peace.ocn.ne.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
| 2025 | Year | 11 | Month | 05 | 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
48
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
| 2023 | Year | 07 | Month | 26 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 26 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 26 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 11 | Month | 04 | Day |
Last modified on
| 2025 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068214
