UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety evaluation of a self-assembling peptide gel for the application as a hemostatic material in dentistry
Title of the study (Brief title)	Safety evaluation of a self-assembling peptide gel in dentistry
Region	Japan

Condition
Condition	Gingivitis
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to evaluate the safety of non-animal derived self-assembling peptide gel, PanaceaGel for the application as a hemostatic material.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I

Assessment
Primary outcomes	Safety
Key secondary outcomes	Hemostatic effect

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	Test product is put on marginl gingiva.
Interventions/Control_2	Placebo product is put on marginal gingiva.
Interventions/Control_3	Conventional product is put on marginal gingiva.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	healthy dentist Person who has 3 teeth with 4-6mm periodontal pockets and bleeding
Key exclusion criteria	excluding "key inclusion criteria"
Target sample size	15

Research contact person
Name of lead principal investigator	Shogo Takashiba
Organization	Okayama University
Division name	Department of Pathophysiology-Periodontal Science, Graduate Schoolof Medicine, Dentistry and Pharmaceutical Sciences
Address	2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
TEL	086-235-6675
Email	stakashi@cc.okayama-u.ac.jp

Public contact
Name of contact person	Shogo Takashiba
Organization	Okayama University
Division name	Department of Pathophysiology-Periodontal Science, Graduate Schoolof Medicine, Dentistry and Pharmac
Address	2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
TEL	086-235-6675
Homepage URL
Email	stakashi@cc.okayama-u.ac.jp

Sponsor
Institute	Okayama Univesity
Institute
Department

Funding Source
Organization	Okayama University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	岡山大学病院

Other administrative information
Date of disclosure of the study information	2012 Year 08 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 08 Month 28 Day
Anticipated trial start date	2012 Year 08 Month 28 Day
Last follow-up date	2012 Year 09 Month 30 Day
Date of closure to data entry	2012 Year 10 Month 31 Day
Date trial data considered complete	2012 Year 12 Month 28 Day
Date analysis concluded	2013 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 08 Month 08 Day
Last modified on	2016 Year 12 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009970