UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046927 |
|---|---|
| Receipt number | R000053539 |
| Scientific Title | Verification of the ameliorating effect of gel containing LYZOX/decanoic acid (D-LYZOX) on gingivitis |
| Date of disclosure of the study information | 2022/02/17 |
| Last modified on | 2024/08/18 11:21:52 |
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Basic information
Public title
The ameliorating effect of gel containing LYZOX on gingivitis
Acronym
The ameliorating effect of LYZOX on gingivitis
Scientific Title
Verification of the ameliorating effect of gel containing LYZOX/decanoic acid (D-LYZOX) on gingivitis
Scientific Title:Acronym
The ameliorating effect of gel containing LYZOX/decanoic acid (D-LYZOX) on gingivitis
Region
| Japan |
Condition
Condition
Gingivitis
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we evaluated the effect of using a gel containing LYZOX/decanoic acid (D-LYZOX) for cleaning the teeth of patients with periodontal disease.
The purpose of this study was to compare the effects of using a gel containing LYZOX/decanoic acid (D-LYZOX) for cleaning the gingiva of patients with periodontal disease before and after the use of the gel.
The purpose of this study is to conduct an exploratory evaluation of the possible effects of the gel containing ZOX on periodontitis. In addition, saliva will be collected from the subjects during the periodontal examination.
In addition, saliva will be collected from the subjects at the same time as the periodontal examination to investigate changes in the oral bacterial population before and after the trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of gingivitis (evaluation items: PPD, CAL, BOP, Plaque Control Recode)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
After the initial examination, take 0.2 grams of LYZOX/decanoic acid (D-LYZOX) gel per jaw twice a day, before waking up and before going to bed, brush your teeth with the designated toothbrush for 5 minutes, and massage your gums with the same toothbrush. The duration of the study is 2 weeks. The duration of the treatment will be 2 weeks, and the same examination will be performed as at the initial visit to evaluate the difference.
Interventions/Control_2
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
At the time of initial examination, periodontal histological examination (evaluation items: PPD, CAL, BOP, Plaque Control Recode) is performed on patients with moderate or excessive gingival bleeding (20 or more remaining teeth, 10 or more periodontal pockets of 4 mm or more and 30 BOP positive sites).
Key exclusion criteria
Persons with missing teeth
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Keiichi |
| Middle name | |
| Last name | Tsukinoki |
Organization
Kanagawa Dental University
Division name
School of Dentistry
Zip code
2388580
Address
82, Inaoka, Yokosuka, Kanagawa
TEL
+81468228866
tsukinoki@kdu.ac.jp
Public contact
Name of contact person
| 1st name | Yohei |
| Middle name | |
| Last name | Kamata |
Organization
Kanagawa Dental University
Division name
School of Dentistry
Zip code
2388580
Address
82, Inaoka, Yokosuka, Kanagawa
TEL
0468228866
Homepage URL
kamata@kdu.ac.jp
Sponsor or person
Institute
Kanagawa Dental University
Institute
Department
Personal name
Funding Source
Organization
Kanagawa Dental 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
KDU IRB
Address
82, Inaoka, Yokosuka, Kanagawa
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
| 2022 | Year | 02 | Month | 17 | 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
Completed
Date of protocol fixation
| 2022 | Year | 02 | Month | 14 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 14 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 20 | Day |
Last follow-up date
| 2023 | 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
| 2022 | Year | 02 | Month | 16 | Day |
Last modified on
| 2024 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053539
