UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029558 |
|---|---|
| Receipt number | R000033772 |
| Scientific Title | Distinction of masticatory function according to the range of mandibulectomy |
| Date of disclosure of the study information | 2017/11/01 |
| Last modified on | 2017/10/15 13:34:28 |
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Basic information
Public title
Distinction of masticatory function according to the range of mandibulectomy
Acronym
Distinction of masticatory function according to the range of mandibulectomy
Scientific Title
Distinction of masticatory function according to the range of mandibulectomy
Scientific Title:Acronym
Distinction of masticatory function according to the range of mandibulectomy
Region
| Japan |
Condition
Condition
Mandibular tumor
Classification by specialty
| Oral surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We attempted to clarify the stomatognathic performance and OHRQoL for types of defects following mandibulectomy using color-changing chewing gum, gummy jelly, the food questionnaire and OHIP.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
color-changing chewing gum, gummy jelly, the food questionnaire and OHIP
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 underwent mandibulectomy and consented to participate in this study were recruited. Patients who have been over 3 months since surgery.
Key exclusion criteria
Patient who is completely impossible to chew or swallow. Patients with severe xerostomia. Patient undergoing chemotherapy. Patient who can not fill in the questionnaire by oneself.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsukasa Tsuchimochi |
Organization
nagoya city university
Division name
oral and maxillofacial surgery
Zip code
Address
1 kawasumi mizuhocho mizuhoku nagoya
TEL
052-858-7302
oral@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Michinori Maeda |
Organization
nagoya city university
Division name
oral and maxillofacial surgery
Zip code
Address
1 kawasumi mizuhocho mizuhoku nagoya
TEL
052-858-7302
Homepage URL
maeda@med.nagoya-cu.ac.jp
Sponsor or person
Institute
nagoya city university
Institute
Department
Personal name
Funding Source
Organization
Non
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
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 | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 12 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 08 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Non
Management information
Registered date
| 2017 | Year | 10 | Month | 15 | Day |
Last modified on
| 2017 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033772
