UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053776 |
|---|---|
| Receipt number | R000061371 |
| Scientific Title | Research on the severity of periodontitis and changes in gut mibrobiota |
| Date of disclosure of the study information | 2024/03/05 |
| Last modified on | 2024/03/04 21:39:08 |
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Basic information
Public title
Relationship between the severity of periodontitis and changes in gut microbiota
Acronym
Relationship between periodontal disease and gut microbiota
Scientific Title
Research on the severity of periodontitis and changes in gut mibrobiota
Scientific Title:Acronym
Research on periodontal disease and changes in gut microbiota
Region
| Japan |
Condition
Condition
Periodontal disease
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the relationship between the severity of periodontits and changes in the gut microbiota by comparing the intestinal flora of patients with slight and severe periodontitis.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Based on the results of the periodontal examination and radiographic examination, patients will be divided into two groups: slight and severe periodontitis, and those who enter an agreement with the analysis will receive a research stool collection kit and questionnaire. Patient will collect a stool sample at home, fill out the medical questionnaire, and mail it to Symbiosis Solutions, Inc. The results of gut microbiota analysis will be provided to the patient, and the results of periodontal examination with ID code will be sent to Symbiosis Solutions, Inc. We will compare and analyze the results of periodontal examinations and gut microbiota. The target number of patients is expected to be 60 (30 patients with slight and 30 patients with severe periodontitis), and statistical analysis will be conducted to compare the severity of periodontitis, clinical parameter of periodontal examinations and gut micorbiota in both groups.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 13 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Periodontal examinations include 1) probing depth (PD), 2) clinical attachment level (CAL), 3) Degree of tooth mobility, 4) Bleeding on probing (BOP), 5) Gingival Index (GI), 6) Plaque Index (PlI), 7) plaque control record (PCR%), 8) Periodontal epithelial surface area (PESA), 9) Periodontal inflammed surface area (PISA), and 10) based on the results of X-ray examination. Patients diagnosed with slight or sever periodontitis.
Key exclusion criteria
Patients who have not taken any antibiotics within the last 3 months of registration date. Smoker.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yorimasa |
| Middle name | |
| Last name | Ogata |
Organization
Nihon University School of Dentistry at Matsudo
Division name
Department of Periodontogy
Zip code
271-8587
Address
2-870-1 Sakaecho-nishi, Matsudo, Chiba
TEL
0473-360-9362
ogata.yorimasa@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Tanatsu |
Organization
Nihon University School of Dentistry at Matsudo
Division name
Research Administration Division
Zip code
271-8587
Address
2-870-1 Sakaecho-nishi, Matsudo, Chiba
TEL
047-360-9273
Homepage URL
tamatsu.masaki@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University
Institute
Department
Personal name
Funding Source
Organization
Symbiosis Solutions 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
Nihon University School of Dentistry at Matsudo
Address
2-870-1 Sakaecho-nishi, Matsudo, Chiba
Tel
047-360-9273
tamatsu.masaki@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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | Month | 05 | 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
| 2024 | Year | 03 | Month | 04 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 09 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 09 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study of the relationship between slight or severe periodontitis and gut microbiota
Management information
Registered date
| 2024 | Year | 03 | Month | 04 | 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=R000061371
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
