Protocol summary

Study aim
Aim was comparison between rigid intermaxillary fixation and using guiding elastic therapy of nonsurgical treatment in mandibular subcondylar fractures.
Design
This evaluation is a clinical trial in phase 3, patients who were diagnosed with mandibular sub condylar fracture and approved by a specialist, were considered as a study group, in this study, 110 patients who met the inclusion criteria were selected. Patients were nonrandomly assigned to two groups, 55 patients in the intervention group and 55 patients in the control group. Based on this, immediately, 1 week, 1 month, 6 months and 1 year after treatment, the patients' condition was evaluated based on their signs and symptoms.
Settings and conduct
This study was performed as a clinical trial of Shahid Bahonar Hospital, also the study was unblinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria included as mandibular sub condylar fracture and satisfaction to participate in the study, and exclusion criteria included as pre-surgical infection.
Intervention groups
In first group fracture was treated with MMF method, which does not require opening or direct manipulation of the fracture site, and in second group patients were treated non-surgically with two methods of hard intermaxillary fixation and guiding elastic therapy.
Main outcome variables
Variables included as malocclusion, decreased mandibular movements, facial asymmetry, mandibular deviation, ankylosis, and pain.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200904048617N1
Registration date: 2020-10-16, 1399/07/25
Registration timing: retrospective

Last update: 2020-10-16, 1399/07/25
Update count: 0
Registration date
2020-10-16, 1399/07/25
Registrant information
Name
ahmad ahrari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3760 4752
Email address
koshk8@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-10, 1398/08/19
Expected recruitment end date
2020-07-09, 1399/04/19
Actual recruitment start date
2019-11-10, 1398/08/19
Actual recruitment end date
2020-07-09, 1399/04/19
Trial completion date
2020-07-09, 1399/04/19
Scientific title
Comparison between rigid intermaxillary fixation and using guiding elastic therapy of nonsurgical treatment in mandibular subcondylar fractures
Public title
Comparison of treatment methods in patients with mandibular subcondylar fractures
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Mandibular subconductal fracture Satisfaction to participate in the study
Exclusion criteria:
Pre-surgical infection
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 110
Actual sample size reached: 110
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
7613747181, Qaraney St, Kerman, Kerman Province
City
Kerman
Province
Kerman
Postal code
7613747181
Approval date
2020-08-03, 1399/05/13
Ethics committee reference number
IR.KMU.REC.1399.300

Health conditions studied

1

Description of health condition studied
Mandibular subconductal fracture
ICD-10 code
S02.8
ICD-10 code description
Fractures of other specified skull and facial bones

Primary outcomes

1

Description
Malocclusion
Timepoint
Immediately, 1 week, 1 month, 6 months and 1 year after treatment
Method of measurement
Clinical observation and examination

2

Description
Reduction of mandibular movements
Timepoint
Immediately, 1 week, 1 month, 6 months and 1 year after treatment
Method of measurement
Clinical observation and examination

3

Description
Facial asymmetry
Timepoint
Immediately, 1 week, 1 month, 6 months and 1 year after treatment
Method of measurement
Clinical observation and examination

4

Description
Mandibular deviation
Timepoint
Immediately, 1 week, 1 month, 6 months and 1 year after treatment
Method of measurement
Clinical observation and examination

5

Description
Ankylosis
Timepoint
Immediately, 1 week, 1 month, 6 months and 1 year after treatment
Method of measurement
Clinical observation and examination

6

Description
Pain
Timepoint
Immediately, 1 week, 1 month, 6 months and 1 year after treatment
Method of measurement
Question from the patient

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The fracture was treated with MMF method, which does not require opening or direct manipulation of the fracture site.
Category
Treatment - Surgery

2

Description
Intervention group: Patients were treated non-surgically with two methods of hard intermaxillary fixation and guiding elastic therapy.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Bahonar Hospital
Full name of responsible person
Saeed Haj Mohammadi
Street address
7613747181, Qaraney St, Kerman, Kerman Province
City
کرمان
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
hajmohamadisaeed@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhti
Street address
7613747181, Qaraney St, Kerman, Kerman Province
City
kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3226 3855
Email
abpardakhty@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Saeed Haj Mohammadi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Oral and Maxillofacial Surgery
Street address
7613747181, Qaraney St, Kerman, Kerman Province
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
hajmohamadisaeed@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Saeed Haj Mohammadi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Oral and Maxillofacial Surgery
Street address
7613747181, Qaraney St, Kerman, Kerman Province
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
hajmohamadisaeed@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Saeed Haj Mohammadi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Oral and Maxillofacial Surgery
Street address
7613747181, Qaraney St, Kerman, Kerman Province
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
hajmohamadisaeed@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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