UMIN-CTR Clinical Trial

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	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
URL(English)	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

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