Protocol summary

Study aim
Comparing the effect of two treatment methods, Arthrocentesis and electrical stimulation of nerves through the skin (TENS), on the complications caused by temporomandibular joint disorders in patients who have already undergone orthognathic treatment
Design
Clinical trial, parallel groups, double-blind, randomized, on 30 patients. The rand function of Excel software was used for randomization
Settings and conduct
This clinical trial study is conducted on patients who refer to the maxillofacial surgery department of Taleghani Hospital. Informed consent will be obtained from all patients. Demographic information of patients will be recorded. The patient and the examiner will be blinded. For the first group, arthrocentesis is performed with the help of two angiokets in the upper joint space with normal saline and corticosteroids, and for the second group (TENS)is performed. the factors of pain level, maximum mouth opening, latrusive and protrusive movements are recorded immediately, after 2weeks and1month by a blind examiner and the results are compared blindly.
Participants/Inclusion and exclusion criteria
Inclusion criteria: male and female patients aged 17 to 40 who have undergone orthognathic surgery and have symptoms in the Temporomandibular joint including pain, restriction in mouth opening and joint noises. Exclusion criteria: systemic musculoskeletal disease; fibromyalgia; previous or current history of cancer; pregnancy; history of radiotherapy and chemotherapy; use of partial and complete prosthesis; history of psychosomatic problems.
Intervention groups
For the first group, Arthrocentesis is performed with normal saline and corticosteroids, and for the second group,(TENS) is performed with the help of a device.
Main outcome variables
The intensity of pain measured by using (VAS), maximum opening of the mouth, the amount of latrusive and protrusive movements

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240103060602N1
Registration date: 2024-03-22, 1403/01/03
Registration timing: prospective

Last update: 2024-03-22, 1403/01/03
Update count: 0
Registration date
2024-03-22, 1403/01/03
Registrant information
Name
Shakila Peymani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7749 5338
Email address
shakila.peymani@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-27, 1403/01/08
Expected recruitment end date
2024-08-20, 1403/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the effect of transcutaneous electrical nerve stimulation(TENS) and Arthrocentesis methods in the treatment of TMJ joint disorders after orthognathic treatment in patients with dentofacial disorders
Public title
A comparative study of the effect of transcutaneous electrical nerve stimulation(TENS) and Arthrocentesis methods in the treatment of TMJ joint disorders after orthognathic treatment in patients with dentofacial disorders
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The age of patients is between 17 and 40 years and the gender of the patients is male and female. patients with TMD problems including pain, restriction in mouth opening , TMJ sounds Patients who have undergone orthognathic surgery. The type of deformity must be known before orthognathic surgery. The average amount and direction of mandibular displacement must be known The average amount of rotation and the direction of rotation of the occlusal plane should be known
Exclusion criteria:
Patients with a history of systemic musculoskeletal diseases. Patients with a history of fibromyalgia. Patients who have previous or current history of cancer. Patients who are pregnant. Patients who have a history of radiotherapy and chemotherapy. Patients who use full and partial dentures. Patients with a history of psychosomatic problems.
Age
From 17 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
First, people are randomly divided into two groups with the help of software (OpenClinicaRandomize). The randomization method is block type. For all of them, primary conservative methods including warm compress, massage, soft diet and preventing mouth opening have been done. For both groups, the treatment process is explained, and if they accept the treatment, informed consent is obtained from them. For the first group, arthrocentesis treatment by two angiokets with injection of normal saline and corticosteroids is used, and for the second group, transcutaneous electrical nerve stimulation treatment is used through the skin.Factors such as the amount of pain, maximum opening of the mouth, lateral and protrusive movements, as well as the amount of rotation of the occlusal plate in orthognathic treatment, the amount of advancement or setback of the mandible, and the type of orthognathic treatment are recorded for each patient before starting the treatment, and the factor of Pain level, maximum mouth opening and the maximum lateral and protrusive movements are recorded immediately, after 2 weeks and 1 month, and the results are compared blindly
Blinding (investigator's opinion)
Double blinded
Blinding description
The evaluation of the factors of pain level, maximum opening of the mouth and lateral movements and protrusive movements will be done immediately and after 2 weeks and 1 month by an examiner who is unaware of the study groups and the surgical process of each group.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of Shahid Beheshti University of Medical Sciences Research Institute of De
Street address
Shahid Beheshti school of dentistry, Daneshjoo BlVD, Velenjak، Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2023-12-27, 1402/10/06
Ethics committee reference number
IR.SBMU.DRC.REC.1402.115

Health conditions studied

1

Description of health condition studied
TMJ disorders
ICD-10 code
S03.4
ICD-10 code description
Sprain and strain of jaw

Primary outcomes

1

Description
Pain intensity in two situations: spontaneous pain and pain during function
Timepoint
Immediately after the intervention, after 2 weeks and after 1 month
Method of measurement
The visual analogue scale (VAS) is rated from 1 to 10. 1-3 is classified as mild pain, 4-6 is moderate pain, and 7-10 is severe pain.

2

Description
Maximum mouth opening
Timepoint
Immediately after the intervention, after 2 weeks and after 1 month
Method of measurement
By ruler in millimeters from Maxillary Incisor teeth to Mandibular Incisor teeth

3

Description
latrusive movement
Timepoint
Immediately after the intervention, after 2 weeks and after 1 month
Method of measurement
By a ruler in millimeters, which is measured as the maximum movement of the dental midline of the Mandible relative to the dental midline of the Maxilla

4

Description
Protrusive movements
Timepoint
Immediately after the intervention, after 2 weeks and after 1 month
Method of measurement
by a ruler in millimeters, which is measured as the maximum movement of the dental midline of the mandible relative to the dental midline of the maxilla

Secondary outcomes

1

Description
The degree of rotation of the occlusal plan relative to the SN axis
Timepoint
Registered during orthognathic surgery.
Method of measurement
By ruler in mm

2

Description
The amount of mandible advancement or set back during orthognathic surgery
Timepoint
Registered during orthognathic surgery
Method of measurement
By ruler in mm

Intervention groups

1

Description
Intervention group: Patients who have TMD after orthognathic surgery and after performing conservative treatments such as warm compresses, soft diet and massage therapy, arthrocentesis treatment with corticosteroid injection is performed for them.
Category
Treatment - Surgery

2

Description
Control group: Patients who have TMD after orthognathic surgery and after performing conservative treatments such as warm compresses, soft diet and massage therapy, TENS treatment or electrical nerve stimulation through the skin is performed for them.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatollah Taleghani hospital
Full name of responsible person
Shakila Peymani
Street address
Taleghani hospital., Arabi St., Yemen St., Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 2560
Email
shakila.peymani@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Research deputy, shahid Beheshti university of medical sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2243 9780
Email
zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shakila Peymani
Position
DMD, Postgraduate student of Oral and Maxillofacial Surgery
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Department of Oral and Maxillofacial surgery, Shahid Beheshti school of dentistry, Daneshjoo BLVD, Velenjak, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2217 5350
Fax
Email
shakila.peymani@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Majid Nemati
Position
Assistant professor in Department of Oral and Maxillofacial Surgery
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Department of Oral and Maxillofacial surgery, Shahid Beheshti school of dentistry, Daneshjoo BLVD, Velenjak, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2217 5350
Fax
Email
Dr.majid.nemati47@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shakila Peymani
Position
DMD, Postgraduate student of Oral and Maxillofacial Surgery
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Department of Oral and Maxillofacial surgery, Shahid Beheshti school of dentistry, Daneshjoo BLVD, Velenjak, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2217 5350
Fax
Email
shakila.peymani@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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