UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023851 |
|---|---|
| Receipt number | R000027476 |
| Scientific Title | Effect of ultrasonic irrigation using SP-T Medical Gurgle on the periodontal pockets with bleeding on probing of periodontitis patients in the maintenance phase |
| Date of disclosure of the study information | 2016/09/07 |
| Last modified on | 2018/09/02 08:46:12 |
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Basic information
Public title
Effect of ultrasonic irrigation using SP-T Medical Gurgle on the periodontal pockets with bleeding on probing of periodontitis patients in the maintenance phase
Acronym
Ultrasonic irrigation using SP-T Medical Gurgle to periodontal pockets with bleeding on probing
Scientific Title
Effect of ultrasonic irrigation using SP-T Medical Gurgle on the periodontal pockets with bleeding on probing of periodontitis patients in the maintenance phase
Scientific Title:Acronym
Ultrasonic irrigation using SP-T Medical Gurgle to periodontal pockets with bleeding on probing
Region
| Japan |
Condition
Condition
periodontitis
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To inhibit the progression of periodontitis by ultrasonic irrigation using SP-T Medical Gurgle
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Disappearance ratio of bleeding on probing after 8 weeks
Key secondary outcomes
The number of P.gingivalis, T.forsythensis and T.denticola in the pockets
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Ultrasonic irrigation using SP-T Medical Gurgle to the periodontal pockets at at 0 and 4 weeks
Interventions/Control_2
Ultrasonic irrigation using tap water to the periodontal pockets at 0 and 4 weeks
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Chronic periodotitis patients that completed initial therapy and prosthetic treatments and has a tooth with probing depth 6 mm or more and bleeding on probing 3 times at four weeks or more intervals
Key exclusion criteria
Patients that hypersensitivity is suspected to cetylpyridinium chloride hydrate.
Patients that are given medicine causing extention or shortening of bleeding time.
Patient with the disease to cause extention or shortening of the bleeding time.
Patient who is given an anticancer drug.
The patient who is given a steroid.
Patient having more than 7.0% of HbA1C.
The patient who was given antimicrobial within six months.
Patient with gingival hyperplasia.
Patient who received the subgingival ultrasonic irrigation using the drug within six months.
Patient with the periodontal abscess.
Target sample size
38
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsutomu Sugaya |
Organization
Hokkaido University Hospital
Division name
Periodontics and Endodontics
Zip code
Address
N14 W5, Kita-ku, Sapporo, Japan
TEL
011-706-4343
sugaya@den.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsutomu Sugaya |
Organization
Hokkaido University Hospital
Division name
Periodontics and Endodontics
Zip code
Address
N14 W5, Kita-ku, Sapporo, Japan
TEL
011-706-4343
Homepage URL
sugaya@den.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 09 | Month | 07 | 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
| 2016 | Year | 08 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 15 | Day |
Date of closure to data entry
| 2018 | Year | 01 | Month | 15 | Day |
Date trial data considered complete
| 2018 | Year | 01 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 30 | Day |
Last modified on
| 2018 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027476
