UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of a point-of-care test kit for the detection of periodontal pathogen in the treatment of periodontal disease: a multi-center study
Title of the study (Brief title)	Evaluation of a test kit for the detection of periodontal pathogen
Region	Japan

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

Objectives
Narrative objectives1	A point-of-care test kit is used to detect or semi-quantify a major periodontal pathogen, Porphyromonas gingivalis in subgingival plaque samples from patients with periodontitis. Its efficacy in assessing disease severity, decision-making for the use of antimicrobial therapy and evaluating the effect of such therapy will be tested.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. To compare the results from a commercial test(PCR-Invader) and the present test kit in control and periodontitis groups at baseline. 2. To compare the results from a commercial test and the present test kit before and after SRP (scaling and root planing) and after the use of Periofeel.
Key secondary outcomes	The following parameters before SRP, after SRP and after the use of Periofeel. 1)Probing pocket depth 2)Bleeding on probing 3)Clinical attachment level 4)Gingival index 5)Plaque indel 6)Tooth mobility

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Device,equipment
Interventions/Control_1	Following SRP, a microbiological assessment using a test kit is performed. Then, minocycline (Periofeel)is locally delivered to positive sites.
Interventions/Control_2	Control (Periodontally healthy individuals)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Periodontitis patients with at least one site with PD 4-5 mm (mild periodontitis). 2. Periodontitis patients with at least one site with PD 6-9 mm (severe periodontitis). 3. Periodontally healthy individuals (control) 4. Those who completed full-mouth scaling before the start of the study (baseline). 5. Those who agreed to participate in the study with written informed consent.
Key exclusion criteria	1. Those with uncontrolled systemic diseases (ex. diabetes, hyperlipidemia, cardiovascular diseases, osteoporosis, autoimmune diseases) 2. Smokers 3. Those with aggressive periodontitis 4. History of antimicrobial treatment within 3 months 5. Those who received SRP within 6 months 6. History of allergic reaction against antimicrobials (especially tetracyclines)
Target sample size	60

Research contact person
Name of lead principal investigator	Hiromasa Yoshie
Organization	Niigata University
Division name	Division of Periodontology, Niigata University Graduate School of Medical and Dental Sciences
Address	2-5274 Gakkocho-dori, Chuo-ku, Niigata 951-8514, Japan
TEL	025-227-2869
Email	yoshie@dent.niigata-u.ac.jp

Public contact
Name of contact person	Toshiya Morozumi
Organization	Niigata University
Division name	Division of Periodontology, Niigata University Graduate School of Medical and Dental Sciences
Address	2-5274 Gakkocho-dori, Chuo-ku, Niigata 951-8514, Japan
TEL	025-227-2869
Homepage URL
Email	moro@dent.niigata-u.ac.jp

Sponsor
Institute	Tokyo Dental College Nihon University School of Dentistry at Matsudo Tsurumi University Niigata University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Showa Yakuhin Kako Co Ltd Denka Seiken Co Ltd
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Showa Yakuhin Kako Co LTD Denka Seiken Co LTD
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	東京歯科大学千葉病院（千葉県） 東京歯科大学水道橋病院（東京都） 日本大学松戸歯学部付属病院（千葉県） 鶴見大学歯学部病院（神奈川県） 新潟大学医歯学総合病院（新潟県）

Other administrative information
Date of disclosure of the study information	2015 Year 09 Month 01 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2013 Year 09 Month 26 Day
Anticipated trial start date	2013 Year 10 Month 03 Day
Last follow-up date	2015 Year 08 Month 31 Day
Date of closure to data entry	2015 Year 09 Month 30 Day
Date trial data considered complete	2015 Year 09 Month 30 Day
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results	http://www.sciencedirect.com/science/article/pii/S0167701215300129
Results
Other related information

Management information
Registered date	2013 Year 10 Month 02 Day
Last modified on	2016 Year 07 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013945