UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of oral function for patients with oral and maxillofacial disorders
Acronym	Evaluation of oral function for patients with oral and maxillofacial disorders
Scientific Title	Evaluation of oral function for patients with oral and maxillofacial disorders
Scientific Title:Acronym	Evaluation of oral function for patients with oral and maxillofacial disorders
Region	Japan

Condition
Condition	Oral and maxillofacial disease
Classification by specialty	Oral surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To establish an individualized treatment strategy for oral reconstruction using the patient's postoperative function as an index.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Improvement of postoperative oral function
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who have lost their jawbone or teeth due to a disease in the maxillofacial region, or who are scheduled for surgery with loss of their jawbone and teeth.
Key exclusion criteria	none
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Hidetaka Middle name Last name Miyashsita
Organization	Keio University
Division name	Division of Dentistry and Oral Surgery, Department of Dentistry and Oral Surgery
Zip code	160-85852
Address	35 Shinanomachi Shinjykuku Tokyo
TEL	03-3353-1211
Email	miyashita@z2.keio.jp

Public contact
Name of contact person	1st name Kanako Middle name Last name Munakata
Organization	Keio University
Division name	Division of Dentistry and Oral Surgery, Department of Dentistry and Oral Surgery
Zip code	160-85852
Address	35 Shinanomachi Shinjykuku Tokyo
TEL	03-3353-1211
Homepage URL
Email	munakatakanako@keio.jp

Sponsor
Institute	Keio University
Institute
Department

Funding Source
Organization	none
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	Keio University
Address	35 Shinanomachi Shinjykuku Tokyo
Tel	03-3353-1211
Email	med-rinri-jimu@adst.keio.ac.jp

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	2022 Year 03 Month 18 Day

Related information
URL releasing protocol
Publication of results	Unpublished

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	2021 Year 02 Month 24 Day
Date of IRB	2021 Year 02 Month 24 Day
Anticipated trial start date	2022 Year 04 Month 01 Day
Last follow-up date	2026 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	We will review masticatory function tests and QOL surveys performed on patients in need of oral reconstructive treatment, and quantitatively analyze the effects of standard reconstructive treatment on oral function and QOL.

Management information
Registered date	2022 Year 03 Month 15 Day
Last modified on	2022 Year 03 Month 15 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053809