UMIN-CTR Clinical Trial

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

Periodontitis

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Niigata University

Institute

Department

Personal name

Organization

Sunstar Inc.

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

State University of New York at Buffalo

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

新潟大学医歯学総合病院（新潟県）

Date of disclosure of the study information

2019

Year

02

Month

26

Day

URL releasing protocol

Publication of results

Partially published

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

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 related 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