UMIN-CTR Clinical Trial

Basic information
Public title	Effect of mouthwash containing deciduous dental pulp stem cell culture supernatant on periodontitis
Acronym	Effect of mouthwash containing stem cell culture supernatant on periodontitis
Scientific Title	Effect of mouthwash containing deciduous dental pulp stem cell culture supernatant on periodontitis
Scientific Title:Acronym	Effect of mouthwash containing stem cell culture supernatant on periodontitis
Region	Japan

Condition
Condition	periodontitis
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study was to perform gargle with a mouthwash containing human deciduous dental pulp stem cell culture supernatant for one month in patients with periodontitis and analyze whether or not there is a therapeutic effect on periodontopathic bacteria and periodontitis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Mouthwash was used 3 times a day (about 10 ml once for 1 minute) for 1 month, and clinical parameters of periodontitis (PPD, CAL, agitation, BOP, GI, PlI and PCR) were measured before and after use. In addition, gingival crevicular fluids were collected from the deepest PPD site three times for 30 seconds using sterile paper point, and five periodontopathic bacteria (P. gingivalis, T. denticola, T. forsythia, P. intermedia, A. Actinomycetemcomitans) were measured.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Gargle with a mouthwash containing human deciduous dental pulp stem cell culture supernatant 3 times a day (10 ml once for 1 minute) for 1 month.
Interventions/Control_2	Gargle with mouthwash of the same ingredients except for human deciduous dental pulp stem cell culture supernatant is used 3 times a day (10 ml once for 1 minute) for 1 month.
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	18 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients with periodontitis who have a periodontal pocket of 5 mm or more after the completion of initial periodontal therapy
Key exclusion criteria	Smokers, patients who have taken antibiotics within the last 3 months
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Yorimasa Middle name Last name Ogata
Organization	Nihon University School of Dentistry at Matsudo
Division name	Department of Periodontology
Zip code	271-8587
Address	2-870-1, Sakaecho-nishi, Matsudo, Chiba
TEL	0473609362
Email	ogata.yorimasa@nihon-u.ac.jp

Public contact
Name of contact person	1st name masaki Middle name Last name Tamatsu
Organization	Nihon University School of Dentistry at Matsudo
Division name	Research Office
Zip code	271-8587
Address	2-870-1, Sakaecho-nishi, Matsudo, Chiba
TEL	0473609274
Homepage URL
Email	tamatsu.masaki@nihon-u.ac.jp

Sponsor
Institute	Nihon University
Institute
Department

Funding Source
Organization	Cysay Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nihon University School of Dentistry at Matsudo
Address	2-870-1, Sakaecho-nishi, Matsudo, Chiba
Tel	0473609274
Email	tamatsu.masaki@nihon-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	日本大学松戸歯学部付属病院

Other administrative information
Date of disclosure of the study information	2021 Year 12 Month 19 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	Terminated
Date of protocol fixation	2020 Year 12 Month 18 Day
Date of IRB	2020 Year 12 Month 18 Day
Anticipated trial start date	2021 Year 03 Month 01 Day
Last follow-up date	2022 Year 12 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The test was discontinued due to lack of approval by the Institutional Review Board.

Management information
Registered date	2020 Year 12 Month 18 Day
Last modified on	2022 Year 06 Month 21 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048845