UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008411 |
|---|---|
| Receipt number | 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 18:23:26 |
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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
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
moro@dent.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009895
