UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Impact of Local Drug Delivery of Minocycline on the Subgingival Microbiota during Supportive Periodontal Therapy: A Pilot Study
Title of the study (Brief title)	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	Kazuhisa Yamazaki
Organization	Niigata University Graduate School of Medical and Dental Sciences
Division name	Division of Oral Science for Health Promotion
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	Kazuhisa Yamazaki
Organization	Niigata University Graduate School of Medical and Dental Sciences
Division name	Division of Oral Science for Health Promotion
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 02 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
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.
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