UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060532 |
|---|---|
| Receipt number | R000069243 |
| Scientific Title | The effect of a tranexamic acid-containing postoperative mouthwash on periodontal regeneration therapy, randomized controlled trial |
| Date of disclosure of the study information | 2026/03/13 |
| Last modified on | 2026/01/31 07:05:53 |
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Basic information
Public title
The effect of postoperative mouthwash on periodontal regeneration therapy
Acronym
postoperative mouthwash trial
Scientific Title
The effect of a tranexamic acid-containing postoperative mouthwash on periodontal regeneration therapy, randomized controlled trial
Scientific Title:Acronym
anti-inflammatory postoperative mouthwash trial
Region
| Japan |
Condition
Condition
chronic periodontitis, moderate to severe
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
For several weeks following periodontal tissue regeneration therapy, mechanical oral hygiene management at the surgical site is not allowed. Therefore, the use of mouthwash is essential. Benzethonium chloride mouthwash, a pharmaceutical product, is widely used. However, the difference in efficacy compared to anti-inflammatory mouthwash containing tranexamic acid remains unclear. Therefore, we will evaluate the effectiveness of these products by administering postoperative management using both benzethonium chloride mouthwash and tranexamic acid-containing mouthwash during postoperative rinsing.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical attachment gain at postoperative 6 month
Key secondary outcomes
Pain assessment at postoperative 2, 7, 14 day, qPCR for bacteria at postoperative 7, 14 day, bone filling and reduction of probing depth at postoperative 6 month
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Use of tranexamic acid mouthwash
Interventions/Control_2
Use of benzethonium chloride Mouthwash
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
The study population consists of patients aged 20 years or older with Stage III-IV periodontitis who visited the Periodontology Department at Nihon University Matsudo Dental Hospital. Selection criteria for subjects were based on re-evaluation findings after subgingival SRP under local anesthesia and radiographic evaluation of vertical intrabony defects with bone loss depth more than 3mm and pocket depth (PD) more than 5mm. Subjects had to consent to undergoing periodontal tissue regeneration therapy (REGROTH).
Key exclusion criteria
1.Smokers 2.Patients with uncontrolled diabetes 3.Those with acute symptoms 4.Those taking medications that may affect periodontal tissues (e.g., phenytoin, nifedipine, cyclosporine A) 5.Pregnant or breastfeeding individuals 6.Those with a history of oral cancer 7.Those with alcohol hypersensitivity.
Target sample size
66
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Nakayama |
Organization
Nihon University School of Dentistry at Matsudo
Division name
Department of periodontology
Zip code
2718587
Address
2-870-1, Sakaecho-Nishi, Matudo, Chiba
TEL
0473609362
nakayama.youhei@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Yohei |
| Middle name | |
| Last name | Nakayama |
Organization
Nihon University School of Dentistry at Matsudo
Division name
Department of periodontology
Zip code
2718587
Address
2-870-1 Sakaecho-Nishi, Natsudo, Chiba
TEL
0473609362
Homepage URL
nakayama.youhei@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University
Institute
Department
Personal name
Funding Source
Organization
Nihon University
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
Nihon University School of Dentistry at Matsudo
Address
2-870-1 Sakaecho-Nishi, Natsudo, Chiba
Tel
0473609362
nakayama.youhei@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
| 2026 | Year | 03 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 01 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 03 | Month | 13 | Day |
Last follow-up date
| 2028 | Year | 03 | 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
| 2026 | Year | 01 | Month | 31 | Day |
Last modified on
| 2026 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069243
