UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of ultrasonic irrigation using SP-T Medical Gurgle on the periodontal pockets with bleeding on probing of periodontitis patients in the maintenance phase
Title of the study (Brief title)	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	Tsutomu Sugaya
Organization	Hokkaido University Hospital
Division name	Periodontics and Endodontics
Address	N14 W5, Kita-ku, Sapporo, Japan
TEL	011-706-4343
Email	sugaya@den.hokudai.ac.jp

Public contact
Name of contact person	Tsutomu Sugaya
Organization	Hokkaido University Hospital
Division name	Periodontics and Endodontics
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 08 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000027476