UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Distinction of masticatory function according to the range of mandibulectomy
Title of the study (Brief title)	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	Tsukasa Tsuchimochi
Organization	nagoya city university
Division name	oral and maxillofacial surgery
Address	1 kawasumi mizuhocho mizuhoku nagoya
TEL	052-858-7302
Email	oral@med.nagoya-cu.ac.jp

Public contact
Name of contact person	Michinori Maeda
Organization	nagoya city university
Division name	oral and maxillofacial surgery
Address	1 kawasumi mizuhocho mizuhoku nagoya
TEL	052-858-7302
Homepage URL
Email	maeda@med.nagoya-cu.ac.jp

Sponsor
Institute	nagoya city university
Institute
Department

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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2014 Year 12 Month 08 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033772