UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Transplantation of oral epithelial sheets cultivated on amniotic membrane for oral mucosal reconstruction.
Title of the study (Brief title)	Transplantation of oral epithelial sheets cultivated on amniotic membrane for oral mucosal reconstruction.
Region	Japan

Condition
Condition	The dental disorders that oral surgery, surgical prosthetic pre-treatment, periodontal surgery that produce an oral mucosal defect.
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Investigation of the possibility of reconstructing the oral mucosal defect using autologous AM-cultivated oral epithelial cells.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	We examined whether oral epithelial cells grown on AM would be effective as a biomaterial using for to the reconstruction of oral mucosa.
Key secondary outcomes

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	Medicine
Interventions/Control_1	The dental disorders that oral surgery, surgical prosthetic pre-treatment, periodontal surgery that produce an oral mucosal defect.
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 undergo oral surgeries and that obtained agreement of research cooperation.
Key exclusion criteria	Intraoral malignant tumor disease patients.
Target sample size	10

Research contact person
Name of lead principal investigator	Narisato KANAMURA
Organization	Kyoto Prefectural University of Medicine
Division name	Dental Medicine, Graduate School of Medical Science
Address	465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, Japan
TEL	075-251-5641
Email	amemiya@koto.kpu-m.ac.jp

Public contact
Name of contact person	Takeshi Amemiya
Organization	Kyoto Prefectural University of Medicine
Division name	Dental Medicine, Graduate School of Medical Science
Address	465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, Japan
TEL	075-251-5641
Homepage URL
Email	amemiya@koto.kpu-m.ac.jp

Sponsor
Institute	Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization	The Grant for Advanced Medical Treatment in Kyoto Prefectural University of Medicine, Grant-in-Aid for Scientific Research from Japan Society for the Promotion of Science.
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	2011 Year 07 Month 06 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2011 Year 04 Month 01 Day
Anticipated trial start date	2011 Year 10 Month 01 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2011 Year 07 Month 06 Day
Last modified on	2019 Year 01 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000006547