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
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
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
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
