the effect of botulinum toxin injection on the masticatory muscle pain, joint click and maximum jaw opening in patients with temporomandibular disorders
Design
Before after non-randomized non-controlled clinical trial on 61 patients selected through intentional sampling during 2018-2017
Settings and conduct
The patients will be selected through census method during 2018-2017 and will undergo Botulinum A toxin injection into the masseter muscle.
All patients will be assessed one week, one month, three months and six mounts after the injection for the before-after difference in the Visual Analysis Scale, joint clicking (during touch) and mouth opening (by measuring the distance between the upper and lower incisors).
Participants/Inclusion and exclusion criteria
The diagnosis of patients was based on medical history and increased muscle stiffness including pain triggers;
individuals over 18 years old who went under the conservative treatment for 3 months are included;
The patients undergoing the surgical procedures or having previous injection of botulinum toxin and heat-treated physiotherapy are excluded.
Intervention groups
A total of 50 units of Dysport botulinum toxin will be injected into the masseter muscle of all patients.
Main outcome variables
presence or absence of joint click by touch; the amount of pain; mouth opening rate were evaluated by measuring the distance between the upper and lower incisors
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130710013938N4
Registration date:2018-04-09, 1397/01/20
Registration timing:registered_while_recruiting
Last update:2018-04-09, 1397/01/20
Update count:0
Registration date
2018-04-09, 1397/01/20
Registrant information
Name
Mohamadali Ghavimi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 5968
Email address
ghavimim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-28, 1396/12/09
Expected recruitment end date
2018-06-02, 1397/03/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Botolinium injection on symptoms reduction in patients with Temporomandibular Disorders
Public title
Effect of Botolinium injection on symptoms reduction in patients with Temporomandibular Disorders
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with temporomandibular disorders whom were under conservative treatment for 3 months
Exclusion criteria:
Patients have been undergone surgical procedures or have history of previous injection of botulinum toxin
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
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 Tabriz University of Medical Sciences
Street address
Central Building of Tabriz University of Medical Sciences, Daneshgah Street, Tabriz, Iran
City
tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2018-02-26, 1396/12/07
Ethics committee reference number
IR.TBZMED.REC.1396.1098
Health conditions studied
1
Description of health condition studied
Temporomandibular Disorder
ICD-10 code
M26.6
ICD-10 code description
Temporomandibular joint disorders
Primary outcomes
1
Description
pain
Timepoint
1 week, 1 month, 3 months and 6 months after injection
Method of measurement
Visual Analogue Scale for pain
2
Description
Temporomandibular joints click sound
Timepoint
1 week, 1 month, 3 months and 6 months after injection
Method of measurement
palpation
3
Description
maximum jaw opening
Timepoint
1 week, 1 month, 3 months and 6 months after injection
Method of measurement
ruler with accuracy up to one millimeter
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with Temporomandibular Disorder undergo total of 50 units of botulinum Dysport toxin injection at the trigger point in the masseter muscle
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Faculty of Dentistry
Full name of responsible person
Atena Afzali Mehr
Street address
Faculty of Dentistry, Tabriz University of Medical Sciences, Golgasht Ave, Tabriz, IRAN
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
nfo@dentistryfac.tbzmed.ac.i
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Ali Ghavimi
Street address
Tabriz University of Medical Sciences, Golgasht Ave, Tabriz, IRAN
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
Ghavimim@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Ali Ghavimi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Maxillofacial surgery
Street address
Tabriz University of Medical Sciences, Golgasht Ave, Tabriz, IRAN
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
Ghavimim@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Ali Ghavimi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Maxillofacial surgeon
Street address
Tabriz University of Medical Sciences, Golgasht Ave, Tabriz, IRAN
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
Ghavimim@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohamd Ali Ghavimi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Maxillofacial surgeon
Street address
Tabriz University of Medical Sciences, Golgasht Ave, Tabriz, IRAN
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
Ghavimim@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
data can be shared anonymously
When the data will become available and for how long
Data will be available from 2019
To whom data/document is available
academic Researchers
Under which criteria data/document could be used
There are no specific conditions
From where data/document is obtainable
Faculty of Dentistry, Tabriz University of Medical Sciences, Golgasht Ave, Tabriz, IRAN
Tel : +98-41-33355965-9
Fax : +98-41-33346977
What processes are involved for a request to access data/document