UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013691 |
|---|---|
| Receipt number | R000015981 |
| Scientific Title | Study of bacterial and serological markers for progression of chronic periodontitis |
| Date of disclosure of the study information | 2014/04/10 |
| Last modified on | 2014/04/10 21:45:45 |
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Basic information
Public title
Study of bacterial and serological markers for progression of chronic periodontitis
Acronym
Study of bacterial and serological markers for progression of chronic periodontitis
Scientific Title
Study of bacterial and serological markers for progression of chronic periodontitis
Scientific Title:Acronym
Study of bacterial and serological markers for progression of chronic periodontitis
Region
| Japan |
Condition
Condition
Chronic periodontitis
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the bacteriological and serological markers for predicting the progression of chronic periodontitis.
Basic objectives2
Safety,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 saliva.
Key secondary outcomes
The number of total bacteria and some periodontopathic bacteria in subgingival plaque.
Serum IgG titer against some periodontopathic bacteria.
Clinical attachment loss
Probing pocket depth
Bleeding on probing
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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. 30 years or older persons who obtained
written informed consent.
2. Possessed a minimum of 20 teeth.
3. Follow-up phase patients of chronic
periodontitis who had finished active
treatment.
Key exclusion criteria
1. Persons who had taken systemic
antibiotics or anti-inflammatory drugs
within 3 months before experiment.
2. Persons who had severe systemic
diseases.
3. Persons who had received scaling and
root planing within the previous 3
months.
4. Persons who are judged to be
unqualified for this study subjects by
investigators.
Target sample size
163
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromasa Yoshie |
Organization
Niigata University
Division name
Graduate School of Medical and Dental Sciences
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
Division name
Medical & Dental Hospital
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
The Japanese Society of Periodontology
Institute
Department
Personal name
Funding Source
Organization
The Japanese Society of Periodontology
Organization
Division
Category of Funding Organization
Other
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
北海道大学歯学部（北海道）、奥羽大学歯学部（福島県）、日本歯科大学新潟生命歯学部（新潟県）、新潟大学歯学部（新潟県）、日本大学松戸歯学部（千葉県）、東京歯科大学（千葉県）、文教通り歯科クリニック（千葉県）、東京医科歯科大学歯学部（東京都）、慶應義塾大学医学部（東京都）、日本大学歯学部（東京都）、日本歯科大学生命歯学部（東京都）、松本歯科大学（長野県）、愛知学院大学歯学部（愛知県）、大阪歯科大学（大阪府）、九州大学歯学部（福岡県）、長崎大学歯学部（長崎県）、鹿児島大学歯学部（鹿児島県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
| 2008 | Year | 09 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This reseach is intended for the follow-up phase patients of chronic periodontitis who had finished active treatment.
Management information
Registered date
| 2014 | Year | 04 | Month | 10 | Day |
Last modified on
| 2014 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015981
