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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008411
Receipt No. R000009895
Scientific Title Biological effects of oral antimicrobial on systemic bacterial infection caused by full-mouth scaling and root planning: a randomized controlled clinical trial
Date of disclosure of the study information 2012/07/12
Last modified on 2019/02/04

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Basic information
Public title Biological effects of oral antimicrobial on systemic bacterial infection caused by full-mouth scaling and root planning: a randomized controlled clinical trial
Acronym Biological effects of oral antimicrobial on systemic bacterial infection secondary to FM-SRP
Scientific Title Biological effects of oral antimicrobial on systemic bacterial infection caused by full-mouth scaling and root planning: a randomized controlled clinical trial
Scientific Title:Acronym 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
1st name
Middle name
Last name Hiromasa Yoshie
Organization Niigata University Graduate School of Medical and Dental Sciences
Division name Division of Periodontology
Zip code
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
1st name
Middle name
Last name Toshiya Morozumi
Organization Niigata University Medical & Dental Hospital
Division name Department of Periodontics
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 01 Month 21 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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