UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058646 |
|---|---|
| Receipt number | R000065563 |
| Scientific Title | Research on periodontal treatment using ultrasonic scaler with hydrogen peroxide photolysis |
| Date of disclosure of the study information | 2025/07/30 |
| Last modified on | 2025/07/30 14:01:54 |
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Basic information
Public title
Research on periodontal treatment using hydrogen peroxide photolysis
Acronym
Research on periodontal treatment using hydrogen peroxide photolysis
Scientific Title
Research on periodontal treatment using ultrasonic scaler with hydrogen peroxide photolysis
Scientific Title:Acronym
Research on periodontal treatment using ultrasonic scaler with hydrogen peroxide photolysis
Region
| Japan |
Condition
Condition
Periodontitis
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will examine the effectiveness of periodontal treatment combined with hydrogen peroxide photolysis technology in improving clinical parameters of periodontal disease and consider the usefulness of Blue Radical P-01.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical attachment level (CAL) 12-14 weeks after treatment
Key secondary outcomes
CAL 4-6 weeks after treatment
Probing depth (PD) 4-6 and 12-14 weeks after treatment
Bleeding on probing (BOP) 4-6 and 12-14 weeks after treatment
plaque Index (PlI) 4-6 and 12-14 weeks after treatment
Plaque Control Record (PCR) 4-6 and 12-14 weeks after treatment
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Blue Radical P-01 is used in combination with subgingival SRP using a hand scaler under local anesthesia.
Interventions/Control_2
Ultrasonic scaler is used in combination with subgingival SRP using a hand scaler under local anesthesia.
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
Stage III/IV periodontitis patients have at least 3 teeth with 6 mm PD or more
Key exclusion criteria
1. smokers
2. having received antibiotic therapy and/or subgingival periodontal therapy in the previous 12 weeks
3. uncontrolled diabetes
4. presence of acute symptoms
5. taking medication affecting the periodontal condition (ex, phenytoin, nifedipine, or cyclosporine A)
6. pregnancy or breastfeeding
7. patients with pacemakers
8. patients with acatalasemia
Target sample size
94
Research contact person
Name of lead principal investigator
| 1st name | Mizuho |
| Middle name | |
| Last name | Takai |
Organization
Nihon University School of Dentistry at Matsudo
Division name
Department of Periodontology
Zip code
271-8587
Address
2-870-1 Sakaecho Nishi, Matsudo City, Chiba
TEL
047-360-9363
takai.mizuho@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Mizuho |
| Middle name | |
| Last name | Takai |
Organization
Nihon University School of Dentistry at Matsudo
Division name
Department of Periodontology
Zip code
271-8587
Address
2-870-1 Sakaecho Nishi, Matsudo City, Chiba
TEL
047-360-9360
Homepage URL
takai.mizuho@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University School of Dentistry at Matsudo
Institute
Department
Personal name
Funding Source
Organization
Nihon University School of Dentistry at Matsudo
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, Matsudo City, Chiba
Tel
047-360-9363
takai.mizuho@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
| 2025 | Year | 07 | Month | 30 | 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
| 2025 | Year | 01 | Month | 20 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 02 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 07 | Month | 30 | Day |
Last modified on
| 2025 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065563
