UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019261 |
|---|---|
| Receipt number | R000022268 |
| Scientific Title | Effect of nutritional counseling with prosthodontic treatment on nutrition intake in partially dentate patients |
| Date of disclosure of the study information | 2015/11/01 |
| Last modified on | 2018/09/07 15:22:25 |
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Basic information
Public title
Effect of nutritional counseling with prosthodontic treatment on nutrition intake in partially dentate patients
Acronym
Effect of nutritional counselling with prosthodontic treatment
Scientific Title
Effect of nutritional counseling with prosthodontic treatment on nutrition intake in partially dentate patients
Scientific Title:Acronym
Effect of nutritional counselling with prosthodontic treatment
Region
| Japan |
Condition
Condition
Missing teeth
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify efficacy of brief nutritional counseling by dentists with prosthodontic treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Dietary intake
Questionnaire: BDHQ (brief-type self-administered diet history questionnaire)
Evaluation interval: pre-treatment,
1, 3 month after treatment
Key secondary outcomes
Blood chemical analysis
Masticatory function
Patient satisfaction
Oral health-related Quality of Life
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
Denture treatment and nutrition counseling (2 times)
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
Patients who are planned to receive
prosthodontic treatment with definitive removable partial dentures.
Key exclusion criteria
-patients who suffer from psychological disease
-patients who have already received
nutritional counselling
- Patients who eat vegetables more than 350g per day
- Patients with peanuts allergy
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Fueki |
Organization
Tokyo Medical and Dental University
Division name
Graduate school, Removable partial denture prosthodontics
Zip code
Address
1-5-45, Yushima 1-chome, Bunkyo-Ku, Tokyo, 113-8549, Japan
TEL
03-5803-5514
kunfu.rpro@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Gen nabeshima |
Organization
Tokyo Medical and Dental University
Division name
Graduate school, Removable partial denture prosthodontics
Zip code
Address
1-5-45, Yushima 1-chome, Bunkyo-Ku, Tokyo, 113-8549, Japan
TEL
03-5803-5517
Homepage URL
g.nabeshima.rpro@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
東京医科歯科大学歯学部附属病院（東京都）Tokyo Medical and dental University Hospital Faculty of Dentistry
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/29761544
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 | 10 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 11 | Day |
Last follow-up date
| 2017 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 07 | Day |
Last modified on
| 2018 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022268
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
