UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A clinical study of treatment for odontogenic maxillary sinusitis
Title of the study (Brief title)	treatment for odontogenic maxillary sinusitis
Region	Japan

Condition
Condition	odontogenic maxillary sinusitis
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To reduce medical costs and increase success of dental treatment in patients with odontogenic maxillary sinusitis, the present aims to: 1)to prove the importance of early detection of periapical disease in upper teeth and necessity of early dental therapeutic intervention (including conservative treatment) of periapical disease in patients who require Endoscopic Sinus Surgery (ESS) and/or tooth extraction before operation(s) is performed 2)to clarify risk factors related to periapical disease that lead to necessity of ESS and/or tooth extraction; elucidation of risk factors would facilitate prevention of periapical disease.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluation of primary outcomes treatment effects is based on sinus CT scans.
Key secondary outcomes	Evaluation of secondary outcomes treatment effects is based on intra-nasal signs and patients' subjective symptoms.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	4
Purpose of intervention	Treatment
Type of intervention	Medicine Maneuver
Interventions/Control_1	Intervention1;dantal treatment(-),ESS(-)
Interventions/Control_2	Intervention2;dental treatment(-),ESS(+)
Interventions/Control_3	Intervention2;dental treatment(+),ESS(-)
Interventions/Control_4	Intervention4;dental treatment(+),ESS(+)
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	100 years-old >
Gender	Male and Female
Key inclusion criteria	Patients presented at Departments of Otolaryngology and Dentistry of the Jikei University School of Medicine and diagnosed with odontogenic maxillary sinusitis (OMS) based on CT images. All enrolled patients fulfilled all 3 CT diagnostic criteria for OMS: 1) peripheral disease of an upper tooth, 2) root apex/-ices of the upper tooth opened to the maxillary sinus, 3) CT shadows within the maxillary sinus.
Key exclusion criteria	Patients opereated Calldwell-Luc surgery, having post operative maxillary cyst, underage.
Target sample size	100

Research contact person
Name of lead principal investigator	Momoko Takeda
Organization	The Jikei University Daian Hospital
Division name	Department of Otolaryngology
Address	4-11-1Izumi-honncyo,Komae city,Tokyo
TEL	03-3480-1151
Email	momoko413@jikei.ac.jp

Public contact
Name of contact person	Momoko Takeda
Organization	The Jikei University Daian Hospital
Division name	Department of Otolaryngology
Address	4-11-1Izumi-honncyo,Komae city,Tokyo
TEL	03-3480-1151
Homepage URL
Email	momoko413@jikei.ac.jp

Sponsor
Institute	The jikei University School of Medicine
Institute
Department

Funding Source
Organization	Department of Otolaryngology, The jikei University School of Medicine
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	東京慈恵会医科大学附属病院

Other administrative information
Date of disclosure of the study information	2017 Year 04 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 04 Month 01 Day
Anticipated trial start date	2017 Year 04 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	2016 Year 11 Month 21 Day
Last modified on	2016 Year 11 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028618