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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025257
Receipt No. R000029052
Scientific Title Effect of basic fibroblast growth factor (bFGF) in combination with natural bone mineral on periodontal regeneration
Date of disclosure of the study information 2017/08/01
Last modified on 2017/08/08

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Basic information
Public title Effect of basic fibroblast growth factor (bFGF) in combination with natural bone mineral on periodontal regeneration
Acronym Effect of bFGF (FGF-2) and natural bone mineral (DBBM) on periodontal regeneration
Scientific Title Effect of basic fibroblast growth factor (bFGF) in combination with natural bone mineral on periodontal regeneration
Scientific Title:Acronym Effect of bFGF (FGF-2) and natural bone mineral (DBBM) 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 bFGF(FGF-2) and natural bone mineral(DBBM) in combination with natural bone mineral 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 6 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 Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Device,equipment
Interventions/Control_1 Use of bFGF (FGF-2; REGROTH) 0.27 mL or 0.47 mL during periodontal surgery
Interventions/Control_2 Use of bFGF (FGF-2; REGROTH) 0.27 mL or 0.47 mL plus natural bone mineral (Bio-Oss) during periodontal surgery
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 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 bFGF or Bio-Oss,or other medications, 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 44

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsushi Saito
Organization Tokyo Dental College
Division name Department of Periodontology
Zip code
Address 2-9-18 Misaki-cho, Chiyoda-ku, Tokyo 1010061 Japan
TEL 03-6380-9172
Email atsaito@tdc.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsushi Saito
Organization Tokyo Dental College
Division name Department of Periodontology
Zip code
Address 2-9-18 Misaki-cho, Chiyoda-ku, Tokyo 1010061 Japan
TEL 03-6380-9172
Homepage URL
Email atsaito@tdc.ac.jp

Sponsor
Institute Department of Periodontology, Tokyo Dental College
Institute
Department

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
Address
Tel
Email

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)
東京歯科大学千葉病院(千葉県)

Other administrative information
Date of disclosure of the study information
2017 Year 08 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
2016 Year 12 Month 05 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 12 Month 13 Day
Last modified on
2017 Year 08 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029052

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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