UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005390
Receipt number 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 15:45:50

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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 or person

Institute

University of Fukui, Fuculty of Medicine

Institute

Department

Personal name



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

Value
https://center6.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