UMIN-CTR Clinical Trial

Basic information
Public title	Clinical study of mid-facial fracture
Acronym	CSMFF
Scientific Title	Risk factors for maxillary sinus pathology after surgery for mid-facial fracture: A multivariate analysis
Scientific Title:Acronym	RAFMSPASFMFAMA
Region	Asia(except Japan)

Condition
Condition	mid-facial fracture
Classification by specialty	Oral surgery Plastic surgery Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aimed to determine the incidence of maxillary sinus pathology after surgery for mid-facial fracture and evaluate associated risk factors.
Basic objectives2	Others
Basic objectives -Others	Incidence and risk factor.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Postoperative maxillary sinus pathology: such as thickening of maxillary sinus mucosa, air-fluid level.
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	3 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients diagnosed with mid-facial fracture involving a maxillary sinus wall who underwent ORIF surgery using titanium plates and screws. All patients underwent CT before surgery and had at least 3 months of postoperative CT follow-up.
Key exclusion criteria	Patients with a history of preoperative sinusitis and/or rhinitis and those with obvious dental lesions (e.g., periapical disease, advanced periodontal disease, and oroantral communication following dentoalveolar surgery) or pre-existing maxillary sinus pathology on CT.
Target sample size	250

Research contact person
Name of lead principal investigator	1st name Lei Middle name Last name Liu
Organization	West China Hospital of Stomatology, Sichuan University
Division name	Department of Oral and Maxillofacial Surgery
Zip code	610041
Address	No 14 3rd Sec of Renminnan Rd, Chengdu, China
TEL	+862885503406
Email	drliulei@163.com

Public contact
Name of contact person	1st name Linli Middle name Last name Jiang
Organization	West China Hospital of Stomatology, Sichuan University
Division name	Department of Oral and Maxillofacial Surgery
Zip code	610041
Address	No 14 3rd Sec of Renminnan Rd, Chengdu, China
TEL	+862885501456
Homepage URL
Email	13281122116@qq.com

Sponsor
Institute	West China Hospital of Stomatology, Sichuan University
Institute
Department

Funding Source
Organization	West China Hospital of Stomatology, Sichuan University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Institutional Review Board, West China Hospital of Stomatology, Sichuan University
Address	No 14 3rd Sec of Renminnan Rd, Chengdu, China
Tel	+862885503684
Email	hxkqlunli@163.com

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	2021 Year 07 Month 29 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	238
Results	A total of 238 patients (totaling 336 maxillary sinuses) were included for analysis. Postoperative maxillary sinus pathology was visualized in 193 of 336 maxillary sinuses (57.44%). Risk factors for postoperative maxillary sinus pathology included number of screws penetrating the maxillary sinus (odds ratio (OR), 1.148; p = 0.003), imperfect maxillary sinus wall fracture reduction (OR, 2.095; p = 0.005), and number of sinus walls involved (OR, 1.533; p = 0.004).
Results date posted	2021 Year 07 Month 29 Day
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	Completed
Date of protocol fixation	2021 Year 07 Month 15 Day
Date of IRB	2021 Year 07 Month 15 Day
Anticipated trial start date	2021 Year 07 Month 15 Day
Last follow-up date	2021 Year 07 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Number of screws implanted in the maxillary sinus, number of screws penetrating the maxillary sinus, and fracture reduction etc. were examined as potential risk factors. Maxillary sinus pathology on postoperative CT was considered the primary outcome for case-control analysis.

Management information
Registered date	2021 Year 07 Month 29 Day
Last modified on	2021 Year 07 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051412