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)
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
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
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
