UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047564 |
|---|---|
| Receipt number | R000054234 |
| Scientific Title | Effect of dietary counselling with prosthetic restoration on the balance of gut microbiome in partially dentate or edentulous patients: A randomized controlled study |
| Date of disclosure of the study information | 2022/04/25 |
| Last modified on | 2025/04/28 08:17:41 |
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Basic information
Public title
Effect of dietary counselling with prosthetic restoration on the balance of gut microbiome in partially dentate or edentulous patients: A randomized controlled study
Acronym
Effect of dietary counselling with prosthetic restoration on the balance of gut microbiome in partially dentate or edentulous patients: A randomized controlled study
Scientific Title
Effect of dietary counselling with prosthetic restoration on the balance of gut microbiome in partially dentate or edentulous patients: A randomized controlled study
Scientific Title:Acronym
Effect of dietary counselling with prosthetic restoration on the balance of gut microbiome in partially dentate or edentulous patients: A randomized controlled study
Region
| Japan |
Condition
Condition
partially or totally edentulous dentition
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of dietary counselling with prosthetic restoration on the diversity of gut microbiome in partially dentate or edentulous patients
Basic objectives2
Others
Basic objectives -Others
The effect of dietary counselling on dietary ballance
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the diversity of gut microbiome
Key secondary outcomes
oral microbiome
diet history
masticatory performance
occlusal force
oral health-related quality of life
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Dietary intervention (15 minutes, once)
Interventions/Control_2
Instruction for denture care (5 minutes, once)
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
Patients who need for recovery of missing teeth with removable denture
Key exclusion criteria
Patients who take antibiotics within 1 month
Patients with neurological and psychological disorders
Patients who receive dietary intervention due to other diseases, such as diabetes or dyslipidaemia
Patients who require dental treatment with occlusal change after denture placement.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yuka |
| Middle name | |
| Last name | Inamochi |
Organization
Institute of Science Tokyo
Division name
Graduate School, Masticatory Function and Health Science
Zip code
113-8549
Address
1-5-45, Yushima, Bunkyo, Tokyo, Japan
TEL
03-5803-5514
y.inamochi.rpro@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Yuka |
| Middle name | |
| Last name | Inamochi |
Organization
Institute of Science Tokyo
Division name
Graduate School, Masticatory Function and Health Science
Zip code
113-8549
Address
1-5-45, Yushima, Bunkyo, Tokyo, Japan
TEL
03-5803-5514
Homepage URL
y.inamochi.rpro@tmd.ac.jp
Sponsor or person
Institute
Institute of Science Tokyo
Institute
Department
Personal name
Funding Source
Organization
Institute of Science Tokyo
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
Ethics Committee of the Faculty of Dentistry, Institute of Science Tokyo
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
Tel
03-5803-5404
d-hyoka.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
| 2022 | Year | 04 | Month | 25 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 04 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 11 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2025 | 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 | 04 | Month | 22 | Day |
Last modified on
| 2025 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054234
