UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045349 |
|---|---|
| Receipt number | R000051102 |
| Scientific Title | Trial of the intraoral peptidase activity of patients with periodontal disease |
| Date of disclosure of the study information | 2021/10/01 |
| Last modified on | 2024/03/04 09:05:53 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluation of the intraoral enzyme activity of patients with periodontal disease
Acronym
Clinical study of patients with periodontal disease
Scientific Title
Trial of the intraoral peptidase activity of patients with periodontal disease
Scientific Title:Acronym
Trial of intraoral peptidase activity
Region
| Japan |
Condition
Condition
periodontal disease
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to clarify the relevance between the severity of periodontal disease and the bacterial peptidase activity.
Basic objectives2
Others
Basic objectives -Others
Bacterial flora analysis of patients with periodontal disease
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Peptidase activity and bacterial flora analysis
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Sampling (saliva, GCF), once
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. The patient who consulted Oral Management Center of Nagasaki University Hospital
2. The patient 20 years or older at the time of the agreement acquisition
3. The patient who received an examination of periodontal tissue
Key exclusion criteria
1. The patient who has difficulty in saliva collection for dry mouth.
2. The patient with the past of antimicrobial and/or the anti-inflammatory dosage for three months before sampling.
3. The patient with the past of the dosage in the periodontal pocket of the antimicrobial.
4. The patient during human DPP4 inhibitor remedy.
5. The previously treated patient with radiation therapy or chemotherapy because of a malignant tumor.
6. The patient who was judged not to participate in this study by us.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Haruka |
| Middle name | |
| Last name | Nishimata |
Organization
Nagasaki University Hospital
Division name
Pediatric Dentistry
Zip code
852-8588
Address
1-7-1 Sakamoto, Nagasaki City
TEL
095-819-7674
nishimata@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Haruka |
| Middle name | |
| Last name | Nishimata |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Pediatric Dentistry
Zip code
852-8588
Address
1-7-1 Sakamoto, Nagasaki City
TEL
095-819-7674
Homepage URL
nishimata@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University Hospital Clinical Research Ethics Committee
Address
1-7-1 Sakamoto, Nagasaki-shi
Tel
095-819-7229
gaibushikin@ml.nagasaki-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
長崎大学病院（長崎県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 10 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 08 | Month | 18 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 12 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 12 | Month | 31 | Day |
Other
Other related information
none
Management information
Registered date
| 2021 | Year | 09 | Month | 02 | Day |
Last modified on
| 2024 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051102
