UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of nutritional counseling with prosthodontic treatment on nutrition intake in partially dentate patients
Title of the study (Brief title)	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	Kenji Fueki
Organization	Tokyo Medical and Dental University
Division name	Graduate school, Removable partial denture prosthodontics
Address	1-5-45, Yushima 1-chome, Bunkyo-Ku, Tokyo, 113-8549, Japan
TEL	03-5803-5514
Email	kunfu.rpro@tmd.ac.jp

Public contact
Name of contact person	Gen nabeshima
Organization	Tokyo Medical and Dental University
Division name	Graduate school, Removable partial denture prosthodontics
Address	1-5-45, Yushima 1-chome, Bunkyo-Ku, Tokyo, 113-8549, Japan
TEL	03-5803-5517
Homepage URL
Email	g.nabeshima.rpro@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 10 Month 07 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.ncbi.nlm.nih.gov/pubmed/29761544
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022268