Determining the effectiveness of Mandibular Wiring method to zygomatic arch for the treatment of Recurrent Tempro-Mandibular Joint Dislocation
Design
Clinical trial study without control group, phase 2, 5 patients.
Settings and conduct
Patients with Recurrent Tempro-Mandibular Joint Dislocation undergo minor surgery. During this surgery, by using a 0.6 mm stainless steel wire, their mandible movements will be limited. First, a hole is made in the anterior-posterior dimension, one centimeter posterior to the anterior border of the ascending mandible, and in the Superior-Inferior dimension, one centimeter above the Occlusal Plan, a hole is made. Then we bring the Owle from the medial side of the zygomatic arch to the medial area of the ramus near the hole, then we tie a 0.6 mm stainless steel wire with the tip of the Owle, we pass the wire through the inside of the arch of the zygoma and from The outer area of the zygomatic arch is brought to the outer part of the Ramos mandible near the hole. Then, by moving the wire back and forth a few times, we make sure that the wire is free. Then we examine the amount of jaw opening, this amount of opening is examined clinically, this amount should be 5 mm less than the dislocation amount. The wire is cut to the specified size and we pass the outer end of the wire through the hole and tie the two ends of the wire on the inside of the ramus.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with Recurrent Tempro-Mandibular Joint Dislocation who have not yet received other common treatments.
Exclusion criteria: People who are prohibited from having surgery.
Intervention groups
This study has an intervention group in which people with Recurrent Tempro-Mandibular Joint Dislocation are treated to the zygomatic arch under Mandibular Wiring.
Main outcome variables
treatment of Recurrent Tempro-Mandibular Joint Dislocation.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170101031697N4
Registration date:2020-11-07, 1399/08/17
Registration timing:retrospective
Last update:2020-11-07, 1399/08/17
Update count:0
Registration date
2020-11-07, 1399/08/17
Registrant information
Name
Afshin Parvizpanah
Name of organization / entity
Hormozgan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 76 3333 6625
Email address
afshin.parvizpanah@hums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-15, 1399/06/25
Expected recruitment end date
2020-10-14, 1399/07/23
Actual recruitment start date
2020-09-15, 1399/06/25
Actual recruitment end date
2020-10-14, 1399/07/23
Trial completion date
2020-10-14, 1399/07/23
Scientific title
Evaluation of Mandibular Wiring to Zygomatic Arch for Recurrent Tempro-Mandibular Joint Dislocation Treatment
Public title
Evaluation of the method of connecting the mandible to the zygomatic arch by wire for the treatment of recurrent temporomandibular joint dislocation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient who has the recurrent Tempro-Mandibular joint dislocation problem.
Patient who has not received any other treatment to resolve the recurrent Tempro-Mandibular joint dislocation problem.
Exclusion criteria:
Patients who have been barred from any surgery.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
5
Actual sample size reached:
5
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Bandar Abbas University of Medical Sciences
Street address
Ethics Committee of Bandar Abbas University of Medical Sciences,Research Deputy Building, Shahid Mohammadi Hospital, Jomhoori Islami Blvd.
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Approval date
2020-09-15, 1399/06/25
Ethics committee reference number
IR.HUMS.REC.1399.325
Health conditions studied
1
Description of health condition studied
Recurrent Tempro-Mandibular Joint Dislocation
ICD-10 code
S03.0
ICD-10 code description
Dislocation of jaw
Primary outcomes
1
Description
The amount of mouth opening before surgery
Timepoint
Before surgery
Method of measurement
Measurements will be done using a ruler per millimeter.
2
Description
The amount of mouth opening after surgery
Timepoint
After surgery
Method of measurement
Measurements will be done using a ruler per millimeter.
3
Description
Success of treatment.
Timepoint
After surgery
Method of measurement
Not to dislocate the temporomandibular joint again will be a sign of successful treatment.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention is surgical. During this surgery, by using a 0.6 mm stainless steel wire, their jaw movements will be limited. First, a hole is made in the anterior-posterior dimension, one centimeter posterior to the anterior border of the ascending mandible, and in the Superior-Inferior dimension, one centimeter above the Occlusal Plan, a hole is made. Then we bring the Owle from the medial side of the zygomatic arch to the medial area of the ramus near the hole, then we tie a 0.6 mm stainless steel wire with the tip of the Owle, we pass the wire through the inside of the arch of the zygoma and from The outer area of the zygomatic arch is cut to the outer part of the Ramos mandible near the hole. Then, by moving the wire back and forth a few times, we make sure that the wire is free and no tissue is stuck. Then we examine the amount of jaw opening, this amount of opening is examined clinically, this amount should be 5 mm less than the dislocation. At the end, the wire is brought to the specified size and we pass the outer end of the wire through the hole and tie the two ends of the wire on the inside of the ramus.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental Clinic of Bandar Abbas Faculty of Dentistry
Full name of responsible person
Hesamoddin Etemadi
Street address
Dental Clinic of Bandar Abbas School of Dentistry, Shahid Naser St, Imam Khomeini Blvd
City
Bandar Abbas
Province
Hormozgan
Postal code
7914964153
Phone
+98 76 3335 0458
Email
mail@hums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Teamour Aghamolai
Street address
Shahid Mohammadi Hospital, Jomhouri Islami St, Imam Khomeini Blvd
City
Bandar Abbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3334 5009
Email
taghamolaei@hums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas 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
Bandare-abbas University of Medical Sciences
Full name of responsible person
Afshin Parvizpanah
Position
Dental Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Shahid Mohammadi Hospital, Jomhouri Islami St, Imam Khomeini Blvd.
City
Bandar Abbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3333 6625
Fax
+98 76 3333 7192
Email
afshin.parvizpanah@hums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Hesamoddin Etemadi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental Clinic of Bandar Abbas School of Dentistry, Shahid Naser St, Imam Khomeini Blvd
City
Bandar Abbas
Province
Hormozgan
Postal code
7914964153
Phone
+98 76 3334 5009
Email
mail@hums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Afshin Parvizpanah
Position
Dental student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Shahid Mohammadi Hospital, Jomhouri Islami St, Imam Khomeini Blvd
City
Bandar Abbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3333 6625
Fax
+98 76 3333 7192
Email
afshin.parvizpanah@hums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The information from this study can be shared without identifying participants.
When the data will become available and for how long
From October 2021
To whom data/document is available
Researchers and referees
Under which criteria data/document could be used
Obtaining a written permit and mentioning the name in the sources and references
From where data/document is obtainable
Afshin Parvizpanah
afshin.parvizpanah@hums.ac.ir
What processes are involved for a request to access data/document
The request must first be emailed and answered after review and approval.