UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000040783 |
|---|---|
| Receipt number | R000046570 |
| Scientific Title | Effect of a novel carbonate apatite in combination with fibroblast growth factor (FGF)-2 on periodontal regeneration |
| Date of disclosure of the study information | 2020/09/01 |
| Last modified on | 2021/04/26 12:52:30 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect of a novel carbonate apatite in combination with fibroblast growth factor (FGF)-2 on periodontal regeneration
Acronym
Effect of FGF-2 and carbonateapatite on periodontal regeneration
Scientific Title
Effect of a novel carbonate apatite in combination with fibroblast growth factor (FGF)-2 on periodontal regeneration
Scientific Title:Acronym
Effect of FGF-2 and carbonateapatite on periodontal regeneration
Region
| Japan |
Condition
Condition
Periodontitis
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare clinical effect of FGF-2+carbonate apatite (CA) and FGF-2+natural bone mineral (DBBM) on periodontal regeneration
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Gain in Clinical Attachment level
(at 9 months after intervention)
Key secondary outcomes
Probing depth
Bleeding on probing
Tooth mobility
Radiographic bone level
Oral health-related QoL score
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
Use of FGF-2 (REGROTH) during periodontal surgery
Interventions/Control_2
Use of FGF-2 (REGROTH) plus natural bone mineral (Bio-Oss) during periodontal surgery
Interventions/Control_3
Use of FGF-2 (REGROTH) plus carbonate apatite (Cytrans) during periodontal surgery
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 with periodontitis who have completed initial periodontal therapy and:
1. with probing depth <= 4 mm
2. with vertical bone defect <= 3 mm
Key exclusion criteria
Patients with uncontrolled systemic diseases, those with allergic reactions to FGF-2, Bio-Oss, or Cytrans those with (or had) oral malignant tumor, in pregnancy or nursing, those receiving anti-coagulant drugs or any other drugs that may influence the clinical results.
Target sample size
66
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Saito |
Organization
Tokyo Dental College
Division name
Department of Periodontology
Zip code
1010061
Address
2-9-18 Kanda-Misakicho, Chiyoda-ku, Tokyo 1010061 Japan
TEL
03-6380-9172
atsaito@tdc.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Saito |
Organization
Tokyo Dental College
Division name
Department of Periodontology
Zip code
1010061
Address
2-9-18 Kanda-Misakicho, Chiyoda-ku, Tokyo 1010061 Japan
TEL
03-6380-9172
Homepage URL
atsaito@tdc.ac.jp
Sponsor or person
Institute
Tokyo Dental College
Institute
Department
Personal name
Funding Source
Organization
Tokyo Dental College
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
Ethics Committee of Tokyo Dental College
Address
2-9-18 Kanda-Misakicho, Chiyoda-ku, Tokyo 1010061 Japan
Tel
03-6380-9172
atsaito@tdc.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
東京歯科大学水道橋病院（東京都）
東京歯科大学千葉歯科医療センター（千葉県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 09 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 04 | Month | 21 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 22 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 08 | 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
| 2020 | Year | 06 | Month | 16 | Day |
Last modified on
| 2021 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000046570
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
