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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023851
Receipt No. 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

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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
Email 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
Email sugaya@den.hokudai.ac.jp

Sponsor
Institute Hokkaido University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027476

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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