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Comparison of the effects of pharmacotherapy and action potential simulation therapy in patients with extracapsular temporomandibular disorders

Protocol summary

Study aim
Evaluation of action potential simulation therapy on patients with temporomandibular disorders
Design
Randomized Clinical Trail with control group,parallel groups,none blind,38 patients. Randomization with block randomization of blocks of 4
Settings and conduct
Department of oral surgery,faculty of dentistry,Tehran Islamic Azad Medicine Sciences
Participants/Inclusion and exclusion criteria
All patients diagnosed with mild and moderate temporomandibular disorders according to DC-TMD criteria who do not present with history of trauma to tmj,seizure and epilepsy,having a cardiac pacemaker,current pregnancy, condylar displacement without reduction,candidacy for tmj surgery, and history of orthognatic surgery
Intervention groups
Intervention group:First, a thin layer of lubricating gel is applied at the area between the electrodes and skin. The negative electrode is placed on the origin of the pain (tmj) and the positive electrode is placed on the attachment of masseteric muscle. Each therapeutic session is consisted of a 10-minute intervention with the power of the APS machine starting at 0.2mA and gradually increasing to 0.9mA. 6 therapeutic sessions are necessary as follows: 1st and 2nd session on the first day with a resting phase of 8-9 minutes between sessions 3rd and 4th sessions on the next day with a resting phase of 8-9 minutes between sessions 5th and 6th sessions four days after the initial session with a resting phase of 8-9 minutes between sessions Control group:In the control group pharmacotherapy consisting of Naproxen 500mg twice a day for 4 weeks, cyclobenzaprine 10mg every night before sleeping for 4 weeks, and diazepam 2.5mg 4 times a day for the first week and 5mg 4 times a day for the next three weeks
Main outcome variables
Degree of temporomandibular joint pain,presence or absence of tmj sounds, limitation is lateral movement of the jaw,maximum opening of the jaw

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171216037893N5
Registration date: 2021-06-12, 1400/03/22
Registration timing: registered_while_recruiting

Last update: 2021-06-12, 1400/03/22
Update count: 0
Registration date
2021-06-12, 1400/03/22
Registrant information
Name
Hamidreza Mahaseni aghdam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2240 6440
Email address
h_mahaseni@dentaliau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-10, 1399/12/20
Expected recruitment end date
2021-08-11, 1400/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of pharmacotherapy and action potential simulation therapy in patients with extracapsular temporomandibular disorders
Public title
Evaluation of action potential simulation therapy on patients with temporomandibular disorders
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients diagnosed with mild and moderate temporomandibular disorders according to DC-TMD diagnostic criteria
Exclusion criteria:
History of trauma to temporomandibular joint History of epilepsy and seizure Having cardiac pacemakers Current pregnancy Temporomandibular disc displacement without reduction Candidacy for temporomandibular joint surgery History of orthognatic surgery
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Block Randomization with block size of 4. All patients are aware of the interventions done in both groups.
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 Islamic Azad University of Medical Sciences, Tehran
Street address
No. 9, 9th Neyestan st., Pasdaran st.
City
Tehran
Province
Tehran
Postal code
19585175
Approval date
2021-04-28, 1400/02/08
Ethics committee reference number
IR.IAU.DENTAL.REC.1400.006

Health conditions studied

1

Description of health condition studied
Temporomandibular disorders
ICD-10 code
M26.6
ICD-10 code description
Temporomandibular joint disorders

Primary outcomes

1

Description
Temporomandibular joint pain
Timepoint
prior to intervention, one week after intervention, one month after intervention
Method of measurement
VAS (Visual Analog Scale)

2

Description
Joint sounds
Timepoint
prior to intervention, one week after intervention, one month after intervention
Method of measurement
auscultation with stethoscope

3

Description
Degree of lateral movement of mandible
Timepoint
prior to intervention, one week after intervention, one month after intervention
Method of measurement
measurement with millimetric ruler

4

Description
Oral maximal opening
Timepoint
prior to intervention, one week after intervention, one month after intervention
Method of measurement
measurement with millimetric ruler

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:
Category
Treatment - Devices

2

Description
Control group:
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Department of oral and maxillofacial surgery, faculty of dentistry, tehran islamic azad medical scie
Full name of responsible person
Ramtin Dastgir
Street address
No. 9, 9th Neyestan st., Pasdaran st
City
Tehran
Province
Tehran
Postal code
19585175
Phone
+98 21 2276 3459
Email
ramtin_dastgir@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ramtin Dastgir
Street address
No 9., 9th Neyestan st., Pasdaran st.
City
Tehran
Province
Tehran
Postal code
19585175
Phone
+98 21 2276 3459
Email
ramtin_dastgir@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Hamidreza Mahaseni aghdam
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental faculty, 9th neyestan street, pasdaran street
City
Tehran
Province
Tehran
Postal code
19585175
Phone
+98 21 2240 6440
Fax
Email
h_mahaseni@dentaliau.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hamidreza Mahaseni aghdam
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental faculty, 9th neyestan street, pasdaran street
City
Tehran
Province
Tehran
Postal code
19585175
Phone
+98 21 2240 6440
Fax
Email
h_mahaseni@dentaliau.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hamidreza Mahaseni aghdam
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental faculty, 9th neyestan street, pasdaran street
City
Tehran
Province
Tehran
Postal code
19585175
Phone
+98 21 2240 6440
Fax
Email
h_mahaseni@dentaliau.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
Yes - There is a plan to make this available
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
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
Title and more details about the data/document
All data of participants is subject to sharing after anonymiztion
When the data will become available and for how long
Access to data granted after publication of results
To whom data/document is available
Researchers affiliated with universities
Under which criteria data/document could be used
Data can be utilized in other articles including systematic reviews. No alteration to the data is granted
From where data/document is obtainable
Dr. Hamidreza Mahaseni Aghdam : h_mahaseni@dentaliau.ac.ir Ramtin Dastgir : ramtin_dastgir@yahoo.com
What processes are involved for a request to access data/document
Request for data must be clear and indicating of intentions and purposes. Data will be shared one month following a request.
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