UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055502 |
|---|---|
| Receipt number | R000063417 |
| Scientific Title | The effect of chemical mouthwash on halitosis and oral microbiome in orthodontic patients: a randomized clinical trial. |
| Date of disclosure of the study information | 2024/09/17 |
| Last modified on | 2025/10/07 18:25:14 |
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Basic information
Public title
The effect of chemical mouthwash on halitosis and oral microbiome in orthodontic patients.
Acronym
The effect of chemical mouthwash on halitosis and oral microbiome in orthodontic patients.
Scientific Title
The effect of chemical mouthwash on halitosis and oral microbiome in orthodontic patients: a randomized clinical trial.
Scientific Title:Acronym
The effect of chemical mouthwash on halitosis and oral microbiome in orthodontic patients
Region
| Japan |
Condition
Condition
malocclusion
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of improving oral malodor with chemical mouthwash on oral microbiome in patients with malocclusion and halitosis undergoing orthodontic treatment using multi-bracket appliances, compared with a control group.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hydrogen sulfide (H2S), Methyl-mercaptan (CH3SH), Dimethyl sulfide ([(CH3)2S])
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
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1.The test group uses Mondamin HABITPRO (Earth Chemical, Tokyo, Japan) three times a day (10 ml, 20 seconds, 14 days (2 weeks), morning, noon and evening mouthwash after brushing).
2.Participants are instructed to maintain normal oral hygiene habits for the duration of the study.
Interventions/Control_2
1.The control group uses a placebo mouthwash made by Earth Chemical (Tokyo, Japan)three times a day (10 ml, 20 seconds, 14 days (2 weeks), morning, noon and evening mouthwash after brushing).
2.Participants are instructed to maintain normal oral hygiene habits for the duration of the study.
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
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Healthy subjects between 18 and 40 years old.
2.Undergoing orthodontic therapy with fixed appliances both in the upper and lower arch with monthly follow-up appointments.
3.In extraction cases patients could be enrolled at least two months after the last extraction.
4.Total initial VSCs levels above the baseline level of 150 ppb.
Key exclusion criteria
Patients with active caries, periodontitis (periodontal pockets 3 mm or more), dental fluorosis/ dysplasia of the teeth, syndromes or other abnormalities of the craniofacial complex, mental problems, subjects smoking or using other tobacco products, taking antibiotics during the last 2 months, use of chlorhexidine or another mouthwash in the last 3 weeks, allergy to cetylpyridinium chloride, and participating in other trials are excluded.
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | Toshiko |
| Middle name | |
| Last name | Sekiya |
Organization
Tsurumi University
Division name
Department of Orthodontics, School of Dental Medicine
Zip code
230-8501
Address
2-1-3, Tsurumi, Tsurumi-ku, Yokohana, Kanagawa
TEL
045-580-8383
sekiya-t@tsurumi-u.ac.jp
Public contact
Name of contact person
| 1st name | Yudai |
| Middle name | |
| Last name | Shimpo |
Organization
Tsurumi University
Division name
Department of Orthodontics, School of Dental Medicine
Zip code
230-8501
Address
2-1-3, Tsurumi, Tsurumi-ku, Yokohana, Kanagawa
TEL
045-580-8438
Homepage URL
shinpo-y@tsurumi-u.ac.jp
Sponsor or person
Institute
Tsurumi University
Institute
Department
Personal name
Funding Source
Organization
Tsurumi University
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
Tsurumi University
Address
2-1-3, Tsurumi, Tsurumi-ku, Yokohana, Kanagawa
Tel
045-580-8318
kyoken@tsurumi-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
| 2024 | Year | 09 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Preinitiation
Date of protocol fixation
| 2024 | Year | 09 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 09 | Month | 13 | Day |
Last modified on
| 2025 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063417
