UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011943 |
|---|---|
| Receipt number | R000013945 |
| Scientific Title | Evaluation of a point-of-care test kit for the detection of periodontal pathogen in the treatment of periodontal disease: a multi-center study |
| Date of disclosure of the study information | 2015/09/01 |
| Last modified on | 2016/07/14 22:00:54 |
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Basic information
Public title
Evaluation of a point-of-care test kit for the detection of periodontal pathogen in the treatment of periodontal disease: a multi-center study
Acronym
Evaluation of a test kit for the detection of periodontal pathogen
Scientific Title
Evaluation of a point-of-care test kit for the detection of periodontal pathogen in the treatment of periodontal disease: a multi-center study
Scientific Title:Acronym
Evaluation of a test kit for the detection of periodontal pathogen
Region
| Japan |
Condition
Condition
Periodontal disease
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A point-of-care test kit is used to detect or semi-quantify a major periodontal pathogen, Porphyromonas gingivalis in subgingival plaque samples from patients with periodontitis. Its efficacy in assessing disease severity, decision-making for the use of antimicrobial therapy and evaluating the effect of such therapy will be tested.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. To compare the results from a commercial test(PCR-Invader) and the present test kit in control and periodontitis groups at baseline.
2. To compare the results from a commercial test and the present test kit before and after SRP (scaling and root planing) and after the use of Periofeel.
Key secondary outcomes
The following parameters before SRP, after SRP and after the use of Periofeel.
1)Probing pocket depth
2)Bleeding on probing
3)Clinical attachment level
4)Gingival index
5)Plaque indel
6)Tooth mobility
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
Following SRP, a microbiological assessment using a test kit is performed. Then, minocycline (Periofeel)is locally delivered to positive sites.
Interventions/Control_2
Control (Periodontally healthy individuals)
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. Periodontitis patients with at least one site with PD 4-5 mm (mild periodontitis).
2. Periodontitis patients with at least one site with PD 6-9 mm (severe periodontitis).
3. Periodontally healthy individuals (control)
4. Those who completed full-mouth scaling before the start of the study (baseline).
5. Those who agreed to participate in the study with written informed consent.
Key exclusion criteria
1. Those with uncontrolled systemic diseases (ex. diabetes, hyperlipidemia, cardiovascular diseases, osteoporosis, autoimmune diseases)
2. Smokers
3. Those with aggressive periodontitis
4. History of antimicrobial treatment within 3 months
5. Those who received SRP within 6 months
6. History of allergic reaction against antimicrobials (especially tetracyclines)
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromasa Yoshie |
Organization
Niigata University
Division name
Division of Periodontology, Niigata University Graduate School of Medical and Dental Sciences
Zip code
Address
2-5274 Gakkocho-dori, Chuo-ku, Niigata 951-8514, Japan
TEL
025-227-2869
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
Division of Periodontology, Niigata University Graduate School of Medical and Dental Sciences
Zip code
Address
2-5274 Gakkocho-dori, Chuo-ku, Niigata 951-8514, Japan
TEL
025-227-2869
Homepage URL
moro@dent.niigata-u.ac.jp
Sponsor or person
Institute
Tokyo Dental College
Nihon University School of Dentistry at Matsudo
Tsurumi University
Niigata University
Institute
Department
Personal name
Funding Source
Organization
Showa Yakuhin Kako Co Ltd
Denka Seiken Co Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Showa Yakuhin Kako Co LTD
Denka Seiken Co LTD
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
東京歯科大学千葉病院（千葉県）
東京歯科大学水道橋病院（東京都）
日本大学松戸歯学部付属病院（千葉県）
鶴見大学歯学部病院（神奈川県）
新潟大学医歯学総合病院（新潟県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
http://www.sciencedirect.com/science/article/pii/S0167701215300129
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
Main results already published
Date of protocol fixation
| 2013 | Year | 09 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 03 | Day |
Last follow-up date
| 2015 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2015 | Year | 09 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 10 | Month | 02 | Day |
Last modified on
| 2016 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013945
