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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007384
Receipt No. R000008702
Scientific Title A randomized controlled clinical trial to examine the microbiological and clinical effects of oral antimicrobials on patients with periodontitis receiving supportive periodontal therapy
Date of disclosure of the study information 2012/03/10
Last modified on 2016/03/27

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Basic information
Public title A randomized controlled clinical trial to examine the microbiological and clinical effects of oral antimicrobials on patients with periodontitis receiving supportive periodontal therapy
Acronym A clinical trial to examine the effects of oral antimicrobials on patients with periodontitis in SPT phase
Scientific Title A randomized controlled clinical trial to examine the microbiological and clinical effects of oral antimicrobials on patients with periodontitis receiving supportive periodontal therapy
Scientific Title:Acronym A clinical trial to examine the effects of oral antimicrobials on patients with periodontitis in SPT phase
Region
Japan

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

Objectives
Narrative objectives1 To examine the effects of 2 different oral antimicrobials on microbiological and clinical parameters in patients with periodontitis in SPT phase.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The number of total bacteria and some periodontopathic bacteria in subgingival plaque
Key secondary outcomes Probing pocket depth(PD)
Bleeding on probing(BOP)
Antibody levels in serum against periodontopathic bacteria Concentration of the drugs in gingival crevicular fluid

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
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. 25 patients
2. Patients take 500mg of test drug per day, once a day for 3 days
Interventions/Control_2 Control group
1. 25 patients.
2. Patients take 200mg of sitafloxacin hydrate (Gracevit) per day for 5 days.
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 1. 20 years or older persons who obtained written informed consent.
2. Persons who have diagnosed as moderate to severe chronic or aggressive periodontitis.
3. Persons who have completed active periodontal treatment and received SPT.
4. Persons who have more than 15 teeth.
5. Persons who have more than 2 teeth with PD more than 5mm and BOP (+)
Key exclusion criteria 1. Persons who received debridement in periodontal pockets for the past one month prior to this study.
2. Persons who received SRP with local anesthesia for the past three month prior to this study.
3. Persons who took antimicrobials (except external use) for the past three month prior to this study.
4. Persons who have the medical history of hypersensitivity to new quinolone or macrolide antimicrobials.
5. Persons who are pregnant or suspected to be pregnant.
6. Persons who have severe diabetes, heart diseases, or dysfunction of kidney or liver.
7. Persons who are judged to be unqualified for this study subjects by investigators.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhisa Yamazaki
Organization Niigata University
Division name Graduate school of medical and oral sciences,
Zip code
Address 2-5274, Gakkocho-dori, Chuo-ku, Niigata, 951-8514, Japan
TEL 025-227-6161
Email kaz@dent.niigata-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takako Nakajima
Organization Niigata University
Division name Medical and dental hospital,
Zip code
Address 2-5274, Gakkocho-dori, Chuo-ku, Niigata, 951-8514, Japan
TEL 025-227-6161
Homepage URL
Email takako@dent.niigata-u.ac.jp

Sponsor
Institute Niigata University Medical and Dental Hospital
Institute
Department

Funding Source
Organization Daiichi-Sankyo Co., LTD
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2012 Year 03 Month 10 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://aac.asm.org/content/early/2016/01/04/AAC.02575-15.abstract
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
2011 Year 09 Month 28 Day
Date of IRB
Anticipated trial start date
2011 Year 11 Month 01 Day
Last follow-up date
2014 Year 11 Month 30 Day
Date of closure to data entry
2014 Year 12 Month 31 Day
Date trial data considered complete
2015 Year 02 Month 28 Day
Date analysis concluded
2015 Year 02 Month 28 Day

Other
Other related information

Management information
Registered date
2012 Year 02 Month 27 Day
Last modified on
2016 Year 03 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008702

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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