UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036010 |
|---|---|
| Receipt number | R000040981 |
| Scientific Title | Impact of Local Drug Delivery of Minocycline on the Subgingival Microbiota during Supportive Periodontal Therapy: A Pilot Study |
| Date of disclosure of the study information | 2019/02/26 |
| Last modified on | 2019/02/26 09:40:16 |
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Basic information
Public title
Impact of Local Drug Delivery of Minocycline on the Subgingival Microbiota during Supportive Periodontal Therapy: A Pilot Study
Acronym
Impact of Local Drug Delivery of Minocycline on the Subgingival Microbiota during Supportive Periodontal Therapy: A Pilot Study
Scientific Title
Impact of Local Drug Delivery of Minocycline on the Subgingival Microbiota during Supportive Periodontal Therapy: A Pilot Study
Scientific Title:Acronym
Impact of Local Drug Delivery of Minocycline on the Subgingival Microbiota during Supportive Periodontal Therapy: A Pilot Study
Region
| Japan |
Condition
Condition
Periodontitis
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to describe the subgingival microbiota in participants receiving minocycline (Periocline) as an adjunct to supra- and subgingival scaling versus those receiving a placebo during the supportive periodontal therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Differences of subgingival microbiota of test group and control group between before and after treatment
Key secondary outcomes
1) Change in the counts of total and red complex bacteria of subgingival plaque of test group and control group between before and after treatment
2) Change in the clinical parameters of before and after treatment between test group and control group
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Periocline ointment is administrated at test site after supra and subgingival scaling. Administration is repeated 3 times with 1-week interval.
Interventions/Control_2
Placebo ointment is administrated at test site after supra and subgingival scaling. Administration is repeated 3 times with 1-week interval.
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
| 35 | years-old | <= |
Age-upper limit
| 78 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) good general health without any remarkable past history except well controlled hypertension, dyslipidemia, and diabetes
2) presence of at least 14 remaining teeth
3) history of chronic or aggressive periodontitis
4) presence of at least 2 teeth with probing pocket depth greater than or equal to 5 mm with concomitant bleeding on probing
Key exclusion criteria
1) use of systemic or local antimicrobials in the past 6 months
2) scaling and root planing treatment under local anesthesia for target teeth in the previous 3 months
3) subgingival mechanical debridement for target teeth in the previous 1 month
4) allergies to conventional tetracycline agents
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhisa Yamazaki |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Division of Oral Science for Health Promotion
Zip code
Address
2-5274 Gakkocho-Dori, Chuo-ku, Niigata, 951-8514 Japan
TEL
81252270744
kaz@dent.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhisa Yamazaki |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Division of Oral Science for Health Promotion
Zip code
Address
2-5274 Gakkocho-Dori, Chuo-ku, Niigata, 951-8514 Japan
TEL
81252270744
Homepage URL
kaz@dent.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
Funding Source
Organization
Sunstar Inc.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
State University of New York at Buffalo
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）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Local administration of Periocline, a minocycline slow-release formulation, was clearly effective for not only red complex bacteria but also emerging periodontopathic bacteria. However, the duration of effect was at least 4 weeks but cannot be maintained during regular SPT interval. Although the bacterial composition returned dysbiotic at 8 weeks, % sites showing BOP was remained low at 8 weeks suggesting that bacterial composition is not inflammophilic and may be different from that at baseline.
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
| 2016 | Year | 02 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | 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
| 2019 | Year | 02 | Month | 26 | Day |
Last modified on
| 2019 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040981
