UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055260 |
|---|---|
| Receipt number | R000063031 |
| Scientific Title | The Impact of Periodontal Treatment on the Oral Microbiota in Dementia Patients |
| Date of disclosure of the study information | 2024/09/30 |
| Last modified on | 2024/08/16 16:23:27 |
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Basic information
Public title
The Impact of Periodontal Treatment on the Oral Microbiota in Dementia Patients
Acronym
The Impact of Periodontal Treatment on the Oral Microbiota in Dementia Patients
Scientific Title
The Impact of Periodontal Treatment on the Oral Microbiota in Dementia Patients
Scientific Title:Acronym
The Impact of Periodontal Treatment on the Oral Microbiota in Dementia Patients
Region
| Japan |
Condition
Condition
Periodontitis
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we will target periodontal patients aged 65 and over, collecting saliva and blood samples from patients with dementia, patients with mild cognitive impairment (MCI), and healthy individuals as a control group. Using next-generation sequencing for comprehensive analysis, we aim to identify specific bacteria that change in correlation with cognitive function. By combining this with AI, we will conduct more accurate microbiota analysis than conventional methods, aiming to develop preventive measures, early diagnosis, and fundamental treatments for dementia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in the microbiota before and after periodontal treatment (saliva)
Key secondary outcomes
Improvement of periodontitis
Periodontal tissue examination(pocket depth, bleeding on probing, tooth mobility, plaque control record)
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Individuals with periodontal disease
Age: 65 years or older
Gender: Not specified
Individuals who have received sufficient explanation about this study and have provided written consent of their own free will.
Key exclusion criteria
Edentulous individuals
Individuals diagnosed with infectious diseases such as hepatitis B, hepatitis C, or HIV
Any other individuals deemed unsuitable by the dentist
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Mizutani |
Organization
Tokyo Medical and Dental University
Division name
Department of Periodontology
Zip code
1138519
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
0358035488
natuperi@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Mizutani |
Organization
Tokyo Medical and Dental University Hospital
Division name
Department of Periodontology
Zip code
113-8519
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5488
Homepage URL
mizuperi@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical and Dental University Dental Ethics Review Committee
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
Tel
0358035404
rinri.adm@tmd.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 | 09 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 08 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Research Procedure:
1. The periodontology department's attending physician will confirm that the patient meets the inclusion criteria and does not violate the exclusion criteria. Afterward, (1) written consent to participate in this study will be obtained based on the patient's free will. (2) The principal investigator (Mizutani) will record the necessary information in the subject identification code list to correspond with the study subjects with their identification codes.
2. After obtaining consent, baseline data collection will involve the collection of samples and information for the following items.
3. Upon completion of basic periodontal treatment, the subjects will undergo saliva collection at rest, blood sampling, and an intraoral examination as part of the following evaluation items.
4. Based on the information obtained in step 2, a cross-sectional analysis will be conducted at Juntendo University using multivariate analysis to explore oral factors that affect systemic conditions. Furthermore, based on the information obtained in steps 2, 3, and 4, a parametric or non-parametric paired test will be performed to compare each parameter before and after dialysis initiation. If any changes are observed, factors influencing these changes will be explored.
Management information
Registered date
| 2024 | Year | 08 | Month | 16 | Day |
Last modified on
| 2024 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063031
