UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Biological effects of oral antimicrobial on systemic bacterial infection caused by full-mouth scaling and root planning: a randomized controlled clinical trial
Title of the study (Brief title)	Biological effects of oral antimicrobial on systemic bacterial infection secondary to FM-SRP
Region	Japan

Condition
Condition	Moderate to severe chronic periodontitis
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate microbiological, serological and clinical effects of oral antimicrobial on systemic bacterial infection secondary to full-mouth scaling and root planning.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Cytokine expression level in serum
Key secondary outcomes	Blood endotoxin level Cytokine expression level in gingival crevicular fluid

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	Test group 1. 30 patients 2. Patients take 2g of test drug, 3 days before full-mouth scaling and root planning.
Interventions/Control_2	Control group 1. 30 patients 2. Patients receive full-mouth scaling and root planning as usual.
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	30 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Moderate to severe chronic periodontitis patients over the age of 30 years 2. Possessed a minimum of 20 teeth 3. Having at least 12 teeth with probing pocket depth (PPD) greater than 5 mm in a full-mouth.
Key exclusion criteria	1. Persons who had received scaling and root planing within the previous 6 months. 2. Persons who had taken systemic antibiotics or anti-inflammatory drugs within 3 months before experiment. 3. Persons who had severe systemic diseases. 4. Persons who is known or suspected hypersensitivity or intolerance to macrolide antibiotic. 5. Smoker 6. Persons who is suspected of having aggressive periodontitis.
Target sample size	60

Research contact person
Name of lead principal investigator	Hiromasa Yoshie
Organization	Niigata University Graduate School of Medical and Dental Sciences
Division name	Division of Periodontology
Address	2-5274 Gakkocho-Dori, Chuo-ku, Niigata, 951-8514 Japan
TEL	0252272871
Email	yoshie@dent.niigata-u.ac.jp

Public contact
Name of contact person	Toshiya Morozumi
Organization	Niigata University Medical & Dental Hospital
Division name	Department of Periodontics
Address	2-5274, Gakkocho-dori, Chuo-ku, Niigata, 951-8514, Japan
TEL	0252272871
Homepage URL
Email	moro@dent.niigata-u.ac.jp

Sponsor
Institute	Niigata University
Institute
Department

Funding Source
Organization	Pfizer Japan Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Department of Periodontology, Tokyo Medical And Dental University Department of Periodontics, Tsurumi University Bunkyo do-ri Dental Clinic Yoshino Dental Office Perio Implant Center
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	新潟大学医歯学総合病院（新潟県） 東京医科歯科大学歯学部附属病院（東京都） 鶴見大学歯学部附属病院（神奈川県） 文教通り歯科クリニック（千葉県） 吉野歯科診療所歯周病インプラントセンター（神奈川県）

Other administrative information
Date of disclosure of the study information	2012 Year 07 Month 12 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 01 Month 21 Day
Anticipated trial start date	2012 Year 07 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	Published
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 07 Month 12 Day
Last modified on	2019 Year 02 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009895