UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination of effectiveness of combination therapy of periodontal tissue regeneration drug Regroth and bone substitute material for periodontal tissue regeneration
Title of the study (Brief title)	Study on combination therapy of Regroth and bone substitute material for periodontal tissue regeneration
Region	Japan

Condition
Condition	Periodontal Disease
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Examination on the effectiveness of combination therapy of Regroth and bone substitute material for regeneration of periodontal tissue destruction by periodontitis
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Increase in new alveolar bone at 9 months after periodontal surgery
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is 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	Application of Regroth only at periodontal surgical treatment
Interventions/Control_2	Combination therapy of Regroth and bone substitute material at periodontal surgical treatment
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Periodontal pocket depth of 4 mm or more, and vertical bone defect of 3 mm or more
Key exclusion criteria	Patients with severe systemic disease Patients who may be pregnant or pregnant Patients with mental illness Patients with hypersensitivity to "Regroth" Patient with malignant tumor in oral cavity or patient with an its history Case of predicted not to able to complete closure of the wound surface when filling with substitute bone material Tooth for severe periodontal disease and tooth extraction adapted tooth
Target sample size	80

Research contact person
Name of lead principal investigator	Hiromichi Yumoto
Organization	Tokushima University Graduate School
Division name	Department of Periodontology and Endodontology
Address	3-18-15 Kuramoto-cho, Tokushima, Tokushima
TEL	088-633-7343
Email	yumoto@tokushima-u.ac.jp

Public contact
Name of contact person	Hiromichi Yumoto
Organization	Tokushima University Graduate School
Division name	Department of Periodontology and Endodontology
Address	3-18-15 Kuramoto-cho, Tokushima, Tokushima
TEL	088-633-7343
Homepage URL
Email	yumoto@tokushima-u.ac.jp

Sponsor
Institute	Tokushima University Hospital
Institute
Department

Funding Source
Organization	Tokushima University Hospital Department of Periodontology and Endodontology
Organization
Division
Category of Funding Organization	Other
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	2018 Year 12 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 11 Month 30 Day
Anticipated trial start date	2018 Year 12 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	2018 Year 10 Month 13 Day
Last modified on	2018 Year 10 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039319