UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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.
Title of the study (Brief title)	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	Manabu Kanazawa
Organization	Tokyo Medical and Dental University
Division name	Graduate school of Medical and Dental Sciences, Gerodontology and Oral Rehabilitation
Address	1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL	03-5803-5563
Email	m.kanazawa.gerd@tmd.ac.jp

Public contact
Name of contact person	Manabu Kanazawa
Organization	Tokyo Medical and Dental University
Division name	Graduate school of Medical and Dental Sciences, Gerodontology and Oral Rehabilitation
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
Email	m.kanazawa.gerd@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020716