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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000020487
Receipt No. 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 2020/07/13

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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
Institute Kyushu university hospital
Institute
Department

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 Open public recruiting
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
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 01 Month 07 Day
Last modified on
2020 Year 07 Month 13 Day


Link to view the page
URL(English) https://upload.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


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