UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040800 |
|---|---|
| Receipt number | R000046583 |
| Scientific Title | Assessment of oral function on oral dryness patients |
| Date of disclosure of the study information | 2020/06/17 |
| Last modified on | 2020/06/17 10:14:03 |
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Basic information
Public title
Assessment of oral function on oral dryness patients
Acronym
Assessment of oral function on oral dryness patients
Scientific Title
Assessment of oral function on oral dryness patients
Scientific Title:Acronym
Assessment of oral function on oral dryness patients
Region
| Japan |
Condition
Condition
Oral dryness
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the relationship between oral dryness and declination of oral function.
Basic objectives2
Others
Basic objectives -Others
Prevention of declination of oral function.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluation of oral dryness.
Key secondary outcomes
Evaluation of dental health condition, occlusal force, tongue and lips exercise function, masticatory efficiency, and swallowing function.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. The participants of this study is who understand the research contents and give a written consent.
2. Patients who came to comprehensive dental care or oral surgery of The Nippon Dental University Niigata Hospital.
3. Healthy elderly without oral dryness and oral dryness patients.
4. Over 65 years old.
Key exclusion criteria
1. This study exclude the participants who cannot understand the research contents and who do not give a written consent.
2. This study exclude the participants who have hope of ceasing to participate in this study.
3. Under 64 years old.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Fumi |
| Middle name | |
| Last name | Mizuhashi |
Organization
The Nippon Dental University School of Life Dentistry at Niigata
Division name
Department of Removable Prosthodontics
Zip code
9518580
Address
1-8 Hamaura-cho, Chuo-ku, Niigata, Niigata
TEL
025-267-1500
fumichan@ngt.ndu.ac.jp
Public contact
Name of contact person
| 1st name | Fumi |
| Middle name | |
| Last name | Mizuhashi |
Organization
The Nippon Dental University School of Life Dentistry at Niigata
Division name
Department of Removable Prosthodontics
Zip code
9518580
Address
1-8 Hamaura-cho, Chuo-ku, Niigata, Niigata
TEL
025-267-1500
Homepage URL
fumichan@ngt.ndu.ac.jp
Sponsor or person
Institute
The Nippon Dental University
Institute
Department
Personal name
Funding Source
Organization
The Nippon Dental University
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
The Nippon Dental University School of Life Dentistry at Niigata
Address
1-8 Hamaura-cho, Chuo-ku, Niigata, Niigata
Tel
025-267-1500
fumichan@ngt.ndu.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
| 2020 | Year | 06 | Month | 17 | 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
| 2020 | Year | 06 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is not intervention study and randomized controlled trial.
Management information
Registered date
| 2020 | Year | 06 | Month | 17 | Day |
Last modified on
| 2020 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046583
| 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 |
