UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051198 |
|---|---|
| Receipt number | R000058395 |
| Scientific Title | A double-blind, randomized controlled trial study on the preventive effect of cetylpyridinium chloride containing mouthwash on gingivitis during orthodontic treatment |
| Date of disclosure of the study information | 2023/06/13 |
| Last modified on | 2023/07/19 14:59:30 |
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Basic information
Public title
A double-blind, randomized controlled trial study on the preventive effect of cetylpyridinium chloride containing mouthwash on gingivitis during orthodontic treatment
Acronym
Verification of the preventive effect of cetylpyridinium chloride-containing mouthwash on gingivitis during orthodontic treatment
Scientific Title
A double-blind, randomized controlled trial study on the preventive effect of cetylpyridinium chloride containing mouthwash on gingivitis during orthodontic treatment
Scientific Title:Acronym
Verification of the preventive effect of cetylpyridinium chloride-containing mouthwash on gingivitis during orthodontic treatment
Region
| Japan |
Condition
Condition
gingivitis
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this study is to clarify the anti-inflammatory effect of cetylpyridinium chloride containing mouthwash on periodontal tissue during orthodontic treatment and changes in oral microbiome.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
bleeding on probing
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Use a cetylpyridinium chloride-containing mouthwash during orthodontic treatment.
Interventions/Control_2
A placebo solution of cetylpyridinium chloride-containing mouthwash is used during orthodontic treatment.
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
| 15 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Subjects with malocclusion who will start orthodontic treatment using multi-bracket appliances
2. Age between 15 and 40 at the time of consent form acquisition
3. Subjects who can obtain written consent from the person regarding participation in this research
Key exclusion criteria
1. Subjects with congenital anomalies such as cleft lip and palate
2. Subjects with diseases such as gingivitis and caries
3. Subjects with systemic diseases or medications that interfere with treatment
4. Subjects who habitually use mouthwash
5. Others who are deemed inappropriate by the principal investigator or co-investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kotaro |
| Middle name | |
| Last name | Tanimoto |
Organization
Hiroshima University Graduate School of Biomedical and Health Sciences
Division name
Department of Orthodontics and Craniofacial Developmental Biology,
Zip code
7348551
Address
1-2-3 Kasumi, Minami Ward, Hiroshima City, Hiroshima Prefecture
TEL
082-257-5685
tkotaro@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Isamu |
| Middle name | |
| Last name | Kado |
Organization
Hiroshima University Graduate School of Biomedical and Health Sciences
Division name
Department of Orthodontics and Craniofacial Developmental Biology
Zip code
734-8551
Address
1-2-3 Kasumi, Minami Ward, Hiroshima City, Hiroshima Prefecture
TEL
082-257-5685
Homepage URL
isamu-kado@hiroshima-u.ac.jp
Sponsor or person
Institute
Ministry of Education, Culture, Sports, Science and Technology
Institute
Department
Personal name
Funding Source
Organization
other
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee for Clinical Research of Hiroshima University
Address
1-2-3 Kasumi, Minami Ward, Hiroshima City, Hiroshima Prefecture
Tel
082-257-1551
iryo-seisaku@office.hiroshima-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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 06 | Month | 13 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 06 | Month | 14 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 11 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 11 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 05 | Month | 30 | Day |
Last modified on
| 2023 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058395
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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