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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036010
Receipt No. 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

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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
Email 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
Email kaz@dent.niigata-u.ac.jp

Sponsor
Institute Niigata University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040981

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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