Comparative Effectiveness of Transcutaneous Electrical Nerve Stimulation, Low Level Laser Therapy and Occlusal Splint in the Treatment of Muscular TMJ Disorders
Determining and comparing the effectiveness of three conservative treatment types on the TMJ patients in 1399 that have referred to the Prosthodontic Department of Shahid Beheshti University.
Design
Clinical trial including control group, with parallel, no blind, cross-over groups on 30 patients. For random selection, random.org has been used.
Settings and conduct
The interventions have been done in the Prosthodontics Department of Shahid Beheshti Dental school University by using occlusal splint, Diode laser, and TENS machine
Participants/Inclusion and exclusion criteria
Requirements for the participants:
Entry criteria:
Patient’s age must be between 20 to 60 years old
Chronic orofacial pain (more than three months) with or without limitation of mouth opening, TMJ sound or TMJ locking.
Diagnosis of Temporomandibular Disorder (pain-related or intra-articular disorders) based on the RDC/TMD diagnosis tools.
Exit criteria:
Recent mandibular fracture
Recent facial trauma history
Congenital/developmental jaw disorders
Treatment history for TMD in the past month
Systemic muscular-joint disease
Fibromyalgia
Current or past cancer history
Skin disorders at the TENS and laser therapy sites
Pregnancy
Radiotherapy and chemotherapy treatment history
Mental disorders
Dental diseases
Wearing partial or complete prosthesis
Intervention groups
In this study patients with temporomandibular disorders with myofascial pain put in three intervention groups: Occlusal Splint Therapy, Laser Therapy and TENS therapy.
Standard treatment guideline for these patients is occlusal splint therapy, therefore in this study occlusal splint group has been considered as the control group.
Main outcome variables
Pain level
Maximum mouth opening
Right lateral mandible movement
Left lateral mandible movement
Protrusion
Eating hard food pain
Eating soft food pain
Speaking pain
Laughing pain
Yawning pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211020052823N1
Registration date:2021-12-22, 1400/10/01
Registration timing:registered_while_recruiting
Last update:2021-12-22, 1400/10/01
Update count:0
Registration date
2021-12-22, 1400/10/01
Registrant information
Name
Nazieh Abdollah Kookhi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3426 7457
Email address
nazikookhi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-11, 1400/08/20
Expected recruitment end date
2022-01-10, 1400/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Effectiveness of Transcutaneous Electrical Nerve Stimulation, Low Level Laser Therapy and Occlusal Splint in the Treatment of Muscular TMJ Disorders
Public title
Comparative Effectiveness of Transcutaneous Electrical Nerve Stimulation, Low Level Laser Therapy and Occlusal Splint in the Treatment of Muscular TMJ Disorders
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. Patient’s age between 20 to 60 years old
2- Chronic Myofascial Pain Disorder for more than 3 months
3- Diagnosis of Temporomandibular Disorder (base on RDC/TMD)
Exclusion criteria:
Recent fracture of mandible bone
History of recent trauma to the face
Congenital disorder of jaws
History of treatment for TMD in the past month
Systemic disease of muscle
Fibromyalgia
History of Cancer
Cutaneous lesion in the site that apply laser and tens
Pregnancy
History of Chemotherapy and Radiotherapy
Psychological Disorder
Dental and Oral Disease
Wearing denture and Partial denture
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Patients assign to 3 treatment groups through randomized block design. Subjects will be divided into 5 blocks of 6 patients for a total of 30 patients. In each block patients are randomly assigned to a specific treatment in Excel. So, in this randomized block design patients will receive random treatment based on their arrival.
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 Shahid Beheshti University of Medical Sciences
Street address
Department of Prosthodontics, School of Dentistry, Shahid Beheshti University of Medical Science, Daneshjou Blvd, Velenjak St, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2020-09-08, 1399/06/18
Ethics committee reference number
IR.SBMU.DRC.REC.1399.028
Health conditions studied
1
Description of health condition studied
Temporomandibular Joint (TMJ) Disorders
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The effect of treatment on Muscular Pain Level
Timepoint
Measuring the Muscular Pain Level at the beginning of the trail, just after treatment, one month, and 3 months after treatment
Method of measurement
Visual Analog Scale
Secondary outcomes
1
Description
Maximum Mouth Opening
Timepoint
Before intervention, just after treatment, 1 month and 3 months after treatment
Method of measurement
Millimeter
2
Description
Right Lateral Movement of Mandible
Timepoint
Before intervention, just after, 1 month and 3 month after treatment
Method of measurement
Millimeters
3
Description
Left Lateral Movement of Mandible
Timepoint
Before intervention, just after, 1 month and 3 months after treatment
Method of measurement
Millimeter
4
Description
Protrusion
Timepoint
Before intervention, just after, 1 month and 3 months after treatment
Method of measurement
Millimeter
5
Description
Pain during eating hard food
Timepoint
Before intervention, just after, 1 month and 3 months after treatment
Method of measurement
Visual Analog Scale
6
Description
Pain during eating soft food
Timepoint
Before intervention, just after, 1 month and 3 months after treatment
Method of measurement
Visual Analog Scale
7
Description
Pain during speaking
Timepoint
Before intervention, just after, 1 month and 3 months after treatment
Method of measurement
Visual Analog Scale
8
Description
Pain during laughing
Timepoint
Before intervention, just after, 1 month and 3 months after treatment
Method of measurement
Visual Analog Scale
9
Description
Pain during yawning
Timepoint
Before intervention, just after, 1 month and 3 months after treatment
Method of measurement
Visual Analog Scale
Intervention groups
1
Description
Control group: Occlusal Splint Group (using for 3 months over night)
Category
Treatment - Devices
2
Description
Intervention group: Low Level Laser Therapy- 8 sessions- on the 18 spots on Temporalis and Masseter Muscle bilaterally