UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017879 |
|---|---|
| Receipt number | R000020716 |
| Scientific Title | Randomized controlled clinical trial : The combined effect of the replacement with new dentures and the provision of simple dietary counseling on the nutritional status of complete denture wearers. |
| Date of disclosure of the study information | 2015/06/12 |
| Last modified on | 2018/12/05 12:42:23 |
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Basic information
Public title
Randomized controlled clinical trial : The combined effect of the replacement with new dentures and the provision of simple dietary counseling on the nutritional status of complete denture wearers.
Acronym
The combined effect of the replacement with new dentures and the simple nutrition counseling for complete denture wearers.
Scientific Title
Randomized controlled clinical trial : The combined effect of the replacement with new dentures and the provision of simple dietary counseling on the nutritional status of complete denture wearers.
Scientific Title:Acronym
The combined effect of the replacement with new dentures and the simple nutrition counseling for complete denture wearers.
Region
| Japan |
Condition
Condition
Edentulous people
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the combined effect of the replacement with new dentures and the provision of simple dietary counseling on the nutritional status of complete denture wearers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Food intakes
Key secondary outcomes
Patient-reported outcome
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
Complete denture fabrication and brief nutrition counseling.(About 3 months)
Interventions/Control_2
Complete denture fabrication and counseling about denture care.(About 3 months)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Edentulous people.
Patients who wear complete denture.
Patients who wish to replace their complete denture.
Patients that can attend on their own.
Patients that we can provide the simple dietary counseling for the person prepare whose meals.
Key exclusion criteria
Xelostomia
Temporomandiblar disorder
orofacial motor disorders
Dementia
Psychiatric disorders
Patients who receive dietary restriction
Facility resident
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Manabu Kanazawa |
Organization
Tokyo Medical and Dental University
Division name
Graduate school of Medical and Dental Sciences, Gerodontology and Oral Rehabilitation
Zip code
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5563
m.kanazawa.gerd@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Manabu Kanazawa |
Organization
Tokyo Medical and Dental University
Division name
Graduate school of Medical and Dental Sciences, Gerodontology and Oral Rehabilitation
Zip code
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5563
Homepage URL
http://www.tmd.ac.jp/ore/patient/patient2/tiral2.html
m.kanazawa.gerd@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 06 | Month | 12 | 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
| 2015 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 11 | Day |
Last modified on
| 2018 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020716
| Research Plan | |
|---|---|
| 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 |
