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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027601
Receipt No. R000031628
Scientific Title Effects of application of soft lining material to mandibular complete denture on mental nerve
Date of disclosure of the study information 2017/06/02
Last modified on 2018/08/09

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Basic information
Public title Effects of application of soft lining material to mandibular complete denture on mental nerve
Acronym Effects of soft lining on the mental nerve
Scientific Title Effects of application of soft lining material to mandibular complete denture on mental nerve
Scientific Title:Acronym Effects of soft lining on the mental nerve
Region
Japan

Condition
Condition Edentulous
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to clarify how wearing of mandibular complete denture with soft lining material affects on mental nerve
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes current perception threshold and pain threshold
Key secondary outcomes patient satisfaction ratings to denture
mastication ability

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 soft lining denture
Interventions/Control_2 conventional denture
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 both maxilla and mandibular denture
Key exclusion criteria individual with pacemaker, the pregnant women,the person who can not read and write
Target sample size 64

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Kimoto suguru
Organization Nihon university school of dentisyry of matsudo
Division name Removable-prosthodontics
Zip code
Address sakaechonishi,Matsudo-shi,Chiba2-870-1
TEL 047-360-9375
Email kimoto.suguru@nihon-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Furokawa sou
Organization Nihon university school of dentisyry of matsudo
Division name Removable prosthodontics
Zip code
Address sakaechonishi,Matsudo-shi,Chiba2-870-1
TEL 047-360-9375
Homepage URL
Email sou.furokawa@gmail.com

Sponsor
Institute Nihon university school of dentisyry of matsudo
Institute
Department

Funding Source
Organization Nihon university school of dentisyry of matsudo
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
Address
Tel
Email

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
2017 Year 06 Month 02 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
21 subjects who agreed to the study protocol assigned as the subjects. They were either randomly allocated into two group:SD, CD.
Among 21 subjects, 10 soft lining denture and 11 conventional denture group were assigned.
There was no significant difference between baseline CPT and PT values.
There was no significant difference between the CPT value and the PT value of each group after the adjustment was completed.
There was no significant difference between the CPT value and the PT value after adjustment of the old denture and new denture in both the conventional denture group and the soft linig denture group.
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
2017 Year 05 Month 30 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 01 Day
Last follow-up date
2018 Year 12 Month 31 Day
Date of closure to data entry
2018 Year 12 Month 31 Day
Date trial data considered complete
2019 Year 12 Month 31 Day
Date analysis concluded
2019 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 06 Month 02 Day
Last modified on
2018 Year 08 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031628

Research Plan
Registered date File name
2018/04/17 2.研究計画書最終版風呂川docx.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


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