UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The evaluation of clinical outcomes and patient-reported outcomes following treatment of intrabony defects using a natural bone mineral and GTR
Title of the study (Brief title)	The evaluation of intrabony defects treatment using a natural bone mineral and GTR
Region	Japan

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

Objectives
Narrative objectives1	This study evaluates the clinical outcomes and patient-reported outcomes following treatment of intrabony defects with application of a natural bone mineral (Bio-Oss) and guided tissue regeneration (Bio-Gide) compared with autograft and Bio-Gide. Using Bio-Oss has the advantage in both patient-related outcome and operation time, since the clinical outcome is comparable to using autograft.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	clinical attachment level(6 month 12 month)
Key secondary outcomes	patient-related outcome

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	A natural bone mineral (Bio-Oss) and guided tissue regeneration (Bio-Gide)
Interventions/Control_2	Autograft and guided tissue regeneration (Bio-Gide)
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	intrabony defect PPD: Probing pocket depth over 6mm. Radiographic evidence of an intrabony component over 4mm.
Key exclusion criteria	(1) Systemic disease that could influence the outcome of therapy. (2) Systemic antibiotics had been used within at least 3 months. (3) Smokers.
Target sample size	40

Research contact person
Name of lead principal investigator	Izumi Yuichi
Organization	Tokyo Medical and Dental University
Division name	Department of Periodontology
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL	03-5803-5488
Email	y-izumi.peri@tmd.ac.jp

Public contact
Name of contact person	Hoshi Shu
Organization	Tokyo Medical and Dental University
Division name	Department of Periodontology
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL	03-5803-5488
Homepage URL
Email	hosperi@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2016 Year 05 Month 30 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 05 Month 30 Day
Anticipated trial start date	2016 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2016 Year 05 Month 18 Day
Last modified on	2017 Year 12 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025760