Therapeutical effect of combined pulsed electromagnetic field and laser photobiomodulation on temporomandibular joint after condyle and sub-condylar fractures treated with closed reduction
The effect of combining pulsed magnetic field and laser photobiomodulation on temporomandibular joint function after closed treatment of condylar and subcondylar fractures with long-term follow-up
Design
A controlled, parallel-group, double-blind, randomized clinical trial. Simple randomization will be followed in the study.
Settings and conduct
After the operation, the same protocol of wire fixation for 2 weeks and then elastic fixation for 4 weeks will be applied to the patients.
After the fixation period is completed, based on the degree of mouth opening, if it is less than 30 mm or there is pain in the fracture area,
In the intervention group, stimulation will be performed in 10 sessions (3 sessions per week). Infrared laser in a low-power manner and a low-intensity magnetic field that does not have any clinical complications. The time of each session will be 15 minutes.
Participants/Inclusion and exclusion criteria
Patients who have suffered condylar or subcondylar fractures of the mandible and have undergone closed treatment with intermaxillary fixation.
Patients under 18 years of age, patients with previous condylar or subcondylar fractures of the mandible or temporomandibular joint disorders, and patients with simultaneous coronoid and zygomatic arch fractures were excluded from the study.
Intervention groups
Patients will be divided into two groups: Group 1: Control group or temporomandibular joint physiotherapy group using conventional methods (warm compresses, abseiling therapy, and finger exercises) and Group 2: Temporomandibular joint physiotherapy group using conventional methods plus a combination of pulsed magnetic field and laser photobiomodulation.
Main outcome variables
Maximum anterior jaw opening
Amount of protrusive and latrosive movements of mandible
Pathological sounds in the temporomandibular joint
Amount of pain in the temporomandibular joint area
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250801066715N1
Registration date:2025-08-11, 1404/05/20
Registration timing:prospective
Last update:2025-08-11, 1404/05/20
Update count:0
Registration date
2025-08-11, 1404/05/20
Registrant information
Name
Milad Baseri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2242 6086
Email address
miladbaseri1377@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2025-08-23, 1404/06/01
Expected recruitment end date
2026-07-23, 1405/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Therapeutical effect of combined pulsed electromagnetic field and laser photobiomodulation on temporomandibular joint after condyle and sub-condylar fractures treated with closed reduction
Public title
Therapeutical effect of combined electromagnetic field and laser on jaw joint after condylar fractures treated with closed reduction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who have isolated fractures of the head or neck of the condyle or subcondylar mandible.
Patients who have only undergone closed treatment with intermaxillary fixation
Patients who experience limitation in opening the mouth or pain in the fracture area after a 6-week fixation period.
Exclusion criteria:
Patients with previous temporomandibular joint disorders
Patients with previous surgeries in the temporomandibular joint area, including temporomandibular joint replacement.
Patients who have limited mouth opening or progressive and lateral movements prior to the fracture
Patients with a history of previous condylar and subcondylar fractures
Patients with concomitant fractures of the coronoid, zygomatic arch, or zygomaticomaxillary complex
Patients with any systemic diseases related to bones and joints
Patients whose condylar and subcondylar fractures have been treated open
Patients whose fractures were caused by fighting
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization based on the Lot system with an allocation ratio of 1:1 will be followed in the study. This randomization sequence will be performed using the Random Allocation Method (Windows software version 2.0) and allocation will be done in opaque sealed envelopes. The software generates random numbers for each patient who intends to enter the study. Based on the initial agreement to assign even and odd numbers to the study groups, these random numbers will be used to assign participants to the groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
The outcome assessor who will assess the patient during follow-up will be blinded to the type of physiotherapy given to that individual. The data analyst will also be blinded to the study groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics committees of Research Institute of Dental Sciences- Shahid Beheshti University of M
Street address
Dentistry Faculty, Shahid Beheshti University of Medical Sciences, Velenjak St., Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2025-07-26, 1404/05/04
Ethics committee reference number
IR.SBMU.DRC.REC.1404.024
Health conditions studied
1
Description of health condition studied
Mandibular condylar and subcondylar fractures
ICD-10 code
S02.6
ICD-10 code description
Fracture of mandible
Primary outcomes
1
Description
Maximum anterior jaw opening
Timepoint
Before surgery and 1, 3, 6, and 12 months after surgery
Method of measurement
Graduated ruler
Secondary outcomes
1
Description
The amount of protrusive and latrosive movement of the mandible
Timepoint
Before surgery and 1, 3, 6, and 12 months after surgery
Method of measurement
Graduated ruler
2
Description
Pain in the temporomandibular joint area
Timepoint
Before surgery and 1, 3, 6, and 12 months after surgery
Method of measurement
Based on patient opinions and VAS scale
3
Description
Pathological sounds in the temporomandibular joint
Timepoint
Before surgery and 1, 3, 6, and 12 months after surgery
Method of measurement
Based on clinical examinations
Intervention groups
1
Description
Control group: Temporomandibular joint physiotherapy group using conventional methods (warm compresses, abseiling therapy, and finger exercises)
Category
Rehabilitation
2
Description
Intervention group: Temporomandibular joint physiotherapy group using the conventional method plus a combination of pulsed magnetic field and laser photobiomodulation.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Fereydoun Pourdanesh
Street address
Shahid Chamran Highway, Yemen Street - Shahid Arabi Street, next to Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1115119857
Phone
+98 21 2243 2560
Email
info@sbmu.ac.ir
2
Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Milad Baseri
Street address
Imam Hossein Square, Shahid Madani Street
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 3000
Email
info@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Yaser Safi
Street address
Dentistry Faculty, Shahid Beheshti University of Medical Sciences, Velenjak St., Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2242 6086
Email
dentit@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?