UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020487
Receipt number R000023485
Scientific Title The study on combined effects of mechanical debridement and local drug delivery system (LDDS) on chronic periodontits.
Date of disclosure of the study information 2016/02/01
Last modified on 2022/07/19 09:40:55

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Basic information

Public title

The study on combined effects of mechanical debridement and local drug
delivery system (LDDS) on chronic periodontits.

Acronym

The study on combined effects of mechanical debridement and local drug
delivery system (LDDS) on chronic periodontits.

Scientific Title

The study on combined effects of mechanical debridement and local drug
delivery system (LDDS) on chronic periodontits.

Scientific Title:Acronym

The study on combined effects of mechanical debridement and local drug
delivery system (LDDS) on chronic periodontits.

Region

Japan


Condition

Condition

chronic periodontitis

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

examine the combined effects of mechanical debridement and local drug
delivery system (LDDS) on chronic periodontitis.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

periodontal pocket depth
time of assesment after 4 weeks and 8 weeks from the start of the study.

Key secondary outcomes

number of porphyromonas gingibalis inside periodontal pockets, bleeding on probing, attachment loss, hs-CRP


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

minocycline ointment
duration of administration 1time/week,for 4 weeks.
dosage
0.5g/time

Interventions/Control_2

saline solution
duration of administration 1time/week,for 4 weeks.
dosage
0.5g/time

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

40 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

*Age over40 years old
*The patients who have more than 10 teeth.
*The patients who have 4mm or more of periodontal pockets more than 30% per oral.
*Document consnt has been obtrained for perticipation in this study.

Key exclusion criteria

*The patients who take medicine that make gingival hyperplagia. (cyclosporine, calcium blocker, phenitoin)
*body mass index BMI over 30kg/m2
*The patients who has acute periodontitis at the initial visit or during this study period.
*The patients who take immunosuppressive drugs, e.g. MTX,cyclosporine and anti-TNF therapy.
*past and current smoker
*more than class3 tooth moobility.
*The patients who visited dental clinic within the past 6 months.
*The patients who took antibiotics within the past 2 months.
*pregnant female
*Subjects who are judged as unsuitable for the study by the investigator for other reason.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Fusanori
Middle name
Last name Nishimura

Organization

Faculty of Dental Science, Kyushu University

Division name

Section of Periodontology

Zip code

8128582

Address

3-1-1 Maidashi Higashi-ku Fukuoka

TEL

092-642-6356

Email

fusanori@dent.kyushu-u.ac.jp


Public contact

Name of contact person

1st name Akiko
Middle name
Last name Yamashita

Organization

Kyushu uuniversity

Division name

periodontics

Zip code

8128582

Address

3-1-1 Maidashi Higashi-ku Fukuoka

TEL

092-642-6358

Homepage URL


Email

fusanori@dent.kyushu-u.ac.jp


Sponsor or person

Institute

Kyushu university hospital

Institute

Department

Personal name



Funding Source

Organization

Japanese Society Of Periodontology

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor

Kanagawa Dental University Hospital, Niigata University Medical & Dental Hospital, Health Sciences University of Hokkaido Hospital, Hiroshimda University Hospital, Tokyo Medical And Dental University Hospital, Osaka University Dental Hospital, Okayama University Hospital

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Center for Clinical and Translational Research(CCTR)

Address

3-1-1 Maidashi Higashi-ku

Tel

092-642-5774

Email

byskenkyu@jimu.kyushu-u.ac.jp


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



Other administrative information

Date of disclosure of the study information

2016 Year 02 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

Recruitment status

Completed

Date of protocol fixation

2015 Year 12 Month 17 Day

Date of IRB

2015 Year 11 Month 25 Day

Anticipated trial start date

2016 Year 02 Month 01 Day

Last follow-up date

2022 Year 03 Month 01 Day

Date of closure to data entry

2022 Year 03 Month 31 Day

Date trial data considered complete

2022 Year 03 Month 31 Day

Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 01 Month 07 Day

Last modified on

2022 Year 07 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023485


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name