UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042791 |
|---|---|
| Receipt number | R000048845 |
| Scientific Title | Effect of mouthwash containing deciduous dental pulp stem cell culture supernatant on periodontitis |
| Date of disclosure of the study information | 2021/12/19 |
| Last modified on | 2022/06/21 15:11:22 |
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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
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
tamatsu.masaki@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048845
