UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005390
Receipt No. R000006395
Scientific Title Clinical study on taste function and ultramicroscopic observation of regenerated fungiform papillae and nerve ending after reconstruction of the chorda tympani nerve
Date of disclosure of the study information 2011/04/06
Last modified on 2012/04/06

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Clinical study on taste function and ultramicroscopic observation of regenerated fungiform papillae and nerve ending after reconstruction of the chorda tympani nerve
Acronym Ultrastructure of regenerated human fungiform papillae
Scientific Title Clinical study on taste function and ultramicroscopic observation of regenerated fungiform papillae and nerve ending after reconstruction of the chorda tympani nerve
Scientific Title:Acronym Ultrastructure of regenerated human fungiform papillae
Region
Japan

Condition
Condition Taste dysfunction
Classification by specialty
Oto-rhino-laryngology Adult Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of the study is to detect regenerated fungiform taste buds and nerve ending after severing the human chorda tympani nerve in the middle ear using transmission electron microcopy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1. Morphological detection of regenerated fungiform taste buds and nerve ending
2. Number of taste buds per papilla
Key secondary outcomes Normalization of electrogustometric threshold

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Severance of chorda tympani nerve
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Case with normal electrogustometric threshold pre-operatively
2. Case with severance of chorda tympani nerve
3. Case with normalization of electrogustometric threshold post-operatively
4. Case without recovery of electrogustometric threshold
Key exclusion criteria Case with abnormal electrogustometric threshold pre-operatively
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takehisa Saito
Organization University of Fukui
Division name Fuculty of Medicine
Zip code
Address Matsuoka-Shimoaizuki 23-3, Eiheiji-cho, Yoshida-gun, Fukui Prefecture
TEL 0776-61-3111(2398)
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takehisa Saito
Organization University of Fukui
Division name Fuculty of Medicine
Zip code
Address Matsuoka-Shimoaizuki 23-3, Eiheiji-cho, Yoshida-gun, Fukui Prefecture
TEL 0776-61-3111(2398)
Homepage URL
Email takehisa@u-fukui.ac.jp

Sponsor
Institute University of Fukui, Fuculty of Medicine
Institute
Department

Funding Source
Organization Ministry of Education, Science and Culture
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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 福井大学病院(福井県)

Other administrative information
Date of disclosure of the study information
2011 Year 04 Month 06 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
After the chorda tympani nerve was severed during middle ear surgery, it was clarified that the taste buds containing taste cells and nerve endings could regenerate in the FP of patients with a recovered taste function. The mean number of taste buds in FP of patients with a completely recovered taste function was significantly smaller (1.9 +/- 1.4/FP, p<0.01) than that of normal subjects (3.8 +/- 2.2/FP). By transmission electron microscopy, four distinct types of cell (type I, II, III, and basal cells) were identified in regenerated taste buds. Nerve fibers and nerve terminals were also found in the taste buds.
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 Completed
Date of protocol fixation
2009 Year 12 Month 25 Day
Date of IRB
Anticipated trial start date
2010 Year 01 Month 01 Day
Last follow-up date
2012 Year 03 Month 01 Day
Date of closure to data entry
2012 Year 04 Month 01 Day
Date trial data considered complete
2012 Year 04 Month 01 Day
Date analysis concluded
2012 Year 04 Month 01 Day

Other
Other related information Saito T, Ito T, Narita N, Yamada T, Manabe Y. Light and electron microscopic observation of regenerated fungiform taste buds in patients with recovered taste function after severing chorda tympani nerve. Ann Otol Rhinol Laryngol 120(11): 713-721, 2011

Management information
Registered date
2011 Year 04 Month 06 Day
Last modified on
2012 Year 04 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006395

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.