UMIN-CTR Clinical Trial

Public title

Biological effects of oral antimicrobial on systemic bacterial infection caused by full-mouth scaling and root planning: a randomized controlled clinical trial

Acronym

Biological effects of oral antimicrobial on systemic bacterial infection secondary to FM-SRP

Scientific Title

Biological effects of oral antimicrobial on systemic bacterial infection caused by full-mouth scaling and root planning: a randomized controlled clinical trial

Scientific Title:Acronym

Biological effects of oral antimicrobial on systemic bacterial infection secondary to FM-SRP

Region

Japan

Condition

Moderate to severe chronic periodontitis

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate microbiological, serological and clinical effects of oral antimicrobial on systemic bacterial infection secondary to full-mouth scaling and root planning.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Cytokine expression level in serum

Key secondary outcomes

Blood endotoxin level
Cytokine expression level in gingival crevicular fluid

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Test group
1. 30 patients
2. Patients take 2g of test drug, 3 days before full-mouth scaling and root planning.

Interventions/Control_2

Control group
1. 30 patients
2. Patients receive full-mouth scaling and root planning as usual.

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

30

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Moderate to severe chronic
periodontitis patients over the age of
30 years
2. Possessed a minimum of 20 teeth
3. Having at least 12 teeth with probing
pocket depth (PPD) greater than 5 mm in
a full-mouth.

Key exclusion criteria

1. Persons who had received scaling and
root planing within the previous 6
months.
2. Persons who had taken systemic
antibiotics or anti-inflammatory drugs
within 3 months before experiment.
3. Persons who had severe systemic
diseases.
4. Persons who is known or suspected
hypersensitivity or intolerance to
macrolide antibiotic.
5. Smoker
6. Persons who is suspected of having
aggressive periodontitis.

Target sample size

60

Name of lead principal investigator

1st name
Middle name
Last name	Hiromasa Yoshie

Organization

Niigata University Graduate School of Medical and Dental Sciences

Division name

Division of Periodontology

Zip code

Address

2-5274 Gakkocho-Dori, Chuo-ku, Niigata, 951-8514 Japan

TEL

0252272871

Email

yoshie@dent.niigata-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Toshiya Morozumi

Organization

Niigata University Medical & Dental Hospital

Division name

Department of Periodontics

Zip code

Address

2-5274, Gakkocho-dori, Chuo-ku, Niigata, 951-8514, Japan

TEL

0252272871

Homepage URL

Email

moro@dent.niigata-u.ac.jp

Institute

Niigata University

Institute

Department

Personal name

Organization

Pfizer Japan Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Department of Periodontology, Tokyo Medical And Dental University
Department of Periodontics, Tsurumi University
Bunkyo do-ri Dental Clinic
Yoshino Dental Office Perio Implant Center

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）
東京医科歯科大学歯学部附属病院（東京都）
鶴見大学歯学部附属病院（神奈川県）
文教通り歯科クリニック（千葉県）
吉野歯科診療所歯周病インプラントセンター（神奈川県）

Date of disclosure of the study information

2012

Year

07

Month

12

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

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

Recruitment status

Completed

Date of protocol fixation

2012

Year

01

Month

21

Day

Date of IRB

Anticipated trial start date

2012

Year

07

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

2012

Year

07

Month

12

Day

Last modified on

2019

Year

02

Month

04

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009895