UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045004
Receipt number R000051412
Scientific Title Risk factors for maxillary sinus pathology after surgery for mid-facial fracture: A multivariate analysis
Date of disclosure of the study information 2021/07/29
Last modified on 2021/07/29 17:50:31

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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 or person

Institute

West China Hospital of Stomatology, Sichuan University

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051412


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name