UMIN-CTR Clinical Trial

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 Atsushi Middle name Last name Saito
Organization	Tokyo Dental College
Division name	Department of Periodontology
Zip code	101-0061
Address	2-9-18 Kanda-Misakicho, Chiyoda-ku, Tokyo 1010061 Japan
TEL	03-6380-9172
Email	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
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	Ethics Committee of Tokyo Dental College
Address	2-9-18 Kanda-Misakicho, Chiyoda-ku, Tokyo 1010061 Japan
Tel	0363809172
Email	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	No longer recruiting
Date of protocol fixation	2016 Year 12 Month 05 Day
Date of IRB	2016 Year 12 Month 13 Day
Anticipated trial start date	2016 Year 12 Month 14 Day
Last follow-up date	2022 Year 03 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	2016 Year 12 Month 13 Day
Last modified on	2021 Year 04 Month 26 Day

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