UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054644 |
|---|---|
| Receipt number | R000062444 |
| Scientific Title | Effects of dietary guidance via a smartphone app in conjunction with dental treatment on food and nutrition intake |
| Date of disclosure of the study information | 2024/08/31 |
| Last modified on | 2024/06/12 17:14:50 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Research on the relationship between dental treatment and diet
Acronym
Dental treatment and diet research
Scientific Title
Effects of dietary guidance via a smartphone app in conjunction with dental treatment on food and nutrition intake
Scientific Title:Acronym
Effects of dental treatment and dietary guidance on food and nutritional intake
Region
| Japan |
Condition
Condition
Missing teeth
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A randomised controlled trial will investigate the effect of dietary guidance using a smartphone app in addition to denture fabrication treatment on the oral function, food and nutritional intake of older adults in need of denture fabrication treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Protein intake
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
Intervention group (dental treatment + use of smartphone application 'Mogmog Diary')
Dental treatment: normal denture treatment.
Dietary guidance using 'Mog Mogu Mogu Diary': once a month.
Interventions/Control_2
Control group (dental treatment only)
Dental treatment: Denture treatment was carried out as usual.
Dummy guidance: Materials on oral frailty (conceptual diagram, OF-5 checklist) were distributed only at the first visit (preoperative assessment) and the contents were explained.
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Persons who meet all of the following requirements shall be employed.
1) Older adults (between 65 and 85 years of age)
2) Patients scheduled for new dentures
3) Those with a food intake diversity score (DVS)5 of 6 or less
4) Smartphone owners
Key exclusion criteria
Persons who fulfil any of the following requirements are excluded.
1) Those who receive regular dietary and/or exercise guidance other than outpatient consultations (e.g. nutritional guidance by a dietician).
2) Persons who, for whatever reason, have difficulty in implementing the content of the dietary and exercise guidance.
3) Persons with dementia
4) Persons who have difficulty in controlling their diet voluntarily, e.g. in an institution.
5) Those whose diary entries have fallen below 16 days/month (at least 4 days/week).
6) Those who have had a month without diary entries for 3 consecutive days (9 entries in total) (at least one "diary entry for 3 consecutive days" per month).
7) Those whose diary entries were found to be fraudulent (e.g. posting the same photograph)
8) Persons who requested to withdraw consent for this study
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Kanazawa |
Organization
Tokyo Medical and Dental University
Division name
Gerodontology and Oral Rehabilitation, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan
Zip code
113-8549
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5379
m.kanazawa.gerd@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Kenta |
| Middle name | |
| Last name | Kashiwazaki |
Organization
Tokyo Medical and Dental University
Division name
Gerodontology and Oral Rehabilitation, Graduate School of Medical and Dental Sciences, Tokyo Medical
Zip code
113-8549
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5379
Homepage URL
k.kashiwazaki.gerd@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Morinaga Dairy Clinico 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
General Affairs Section, Faculty of Dentistry, Tokyo Medical and Dental University
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
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
| 2024 | Year | 08 | Month | 31 | 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 | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 09 | Month | 01 | 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
Management information
Registered date
| 2024 | Year | 06 | Month | 12 | Day |
Last modified on
| 2024 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062444
