UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007384 |
|---|---|
| Receipt number | 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 11:44:42 |
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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
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
takako@dent.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University Medical and Dental Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008702
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| Registered date | File name |
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