UMIN-CTR Clinical Trial

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
Email	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
Email	fumichan@ngt.ndu.ac.jp

Sponsor
Institute	The Nippon Dental University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046583