UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056636 |
|---|---|
| Receipt number | R000064731 |
| Scientific Title | Crossover Study of LYZOX/Decanoic Acid (D-LYZOX)-containing Gel for Improvement of Gingivitis |
| Date of disclosure of the study information | 2025/01/10 |
| Last modified on | 2025/01/06 12:38:09 |
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Basic information
Public title
LYZOX/Decanoic Acid (D-LYZOX)-containing Gel for Improvement of Gingivitis
Acronym
Effect of D-LYZOX-containing gel on gingivitis
Scientific Title
Crossover Study of LYZOX/Decanoic Acid (D-LYZOX)-containing Gel for Improvement of Gingivitis
Scientific Title:Acronym
Crossover Study of D-LYZOX-containing Gel for Improvement of Gingivitis
Region
| Japan |
Condition
Condition
Oral disease
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to conduct a double-blind, randomized, controlled crossover study to verify the effects of the ingredients contained in D-LYZOX in reducing gingival swelling and bleeding by using D-LYZOX for periodontal cleaning in patients with moderate periodontal disease, and to confirm the effects of the antibacterial component among natural materials. The purpose of the study is to confirm the effects of antibacterial ingredients among natural ingredients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation Period and Usage
-The period of use of each D-LYZOX is usually 2 weeks, and evaluation is conducted before and after use.
-Twice a day, upon waking and before bedtime, 0.2 g of D-LYZOX gel per jaw will be applied to the designated toothbrush and the patient will brush his/her teeth for 5 minutes.
Assessment Items and Data Collection
-Endpoints: PISA
Key secondary outcomes
Assessment Items and Data Collection
-Evaluation items: PESA, PPD, CAL, BOP, Plaque Control Recode
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Group A will use LYZOX/D-LYZOX with Decanoic Acid first.
Washout period, a two-week period during which the subjects will use their regular toothpaste.
Interventions/Control_2
Group B will use LYZOX/D-LYZOX without decanoate first.
Washout period, a two-week period during which the subjects will use their regular toothpaste.
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
moderate to severe periodontal disease patients without 1 type allergy
Key exclusion criteria
No periodontal disease; history of type 1 allergy.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Kamata |
Organization
Kanagawa Dental University
Division name
school of Dentistry
Zip code
238-8580
Address
82, Inaoka, Yokosuka, Kanagawa
TEL
046-822-8866
tsukinoki@kdu.ac.jp
Public contact
Name of contact person
| 1st name | keiichi |
| Middle name | |
| Last name | tsukinoki |
Organization
Kanagawa Dental University
Division name
school of Dentistry
Zip code
2380003
Address
82, Inaoka, Yokosuka, Kanagawa
TEL
0468228866
Homepage URL
tsukinoki@kdu.ac.jp
Sponsor or person
Institute
Kanagawa Dental University
Institute
Department
Personal name
Funding Source
Organization
WAKO FILTER TECHNOLOGY Co.,Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kanagawa Dental University
Address
82, Inaoka, Yokosuka, Kanagawa, Japan
Tel
0468251500
graduate@kdu.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
| 2025 | Year | 01 | Month | 10 | 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
| 2025 | Year | 01 | Month | 06 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 01 | 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 | 01 | Month | 06 | Day |
Last modified on
| 2025 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064731
