TMJ DisorderNCT06103110
Effect of Order and Conjugation of Different Photobiomodulation Therapies and Anterior Repositioning Appliance in Management of TMD Cases
A study testing Photobiomodulation in people with TMJ Disorder, run by Mansoura University at 1 site in Egypt.
Trial summary
This study aimed to evaluate the effect of using Low level laser therapy / Infrared led therapy with anterior repositioning appliance in anterior dislocation patients with reduction (ADDwR) concerning: 1. Range of mandibular motion 2. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- TMJ Disorder
- What is being tested?
- Photobiomodulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Oct 2022to 3 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- suffering from TMJ internal derangement with reduction.
- All the included patients show persistent restriction of mouth opening as well as TMJ pain and clicking.
Who cannot join
- Patients suffering from inflammatory or connective tissue diseases,
- neurologic disorders
- history of bony or fibrous adhesion
- gross mechanical restrictions and condylar fractures
- previous TMJ surgery
- TMJ ankylosis
- acute infection
- muscle relaxants, non-steroidal anti-inflammatory drugs within 48 h preoperatively, corticosteroid injection at treatment site within one month or systemic use of corticosteroids within 2 weeks
Trial locations and contacts
1 site in 1 country.
About this study
This study aimed to evaluate the effect of using Low level laser therapy / Infrared led therapy with anterior repositioning appliance in anterior dislocation patients with reduction (ADDwR) concerning:
- Range of mandibular motion
- Helkimo questioner to evaluate :
Read more
A -TMJ function B -Muscle pain C -TMJ pain D - Pain on movement of the mandible
Four groups created randomly each 10 patients as following:-
Group 1: anterior repositioning appliance followed by Infra-red LED therapy Group 2: Infra-red LED therapy followed by anterior repositioning appliance Group 3: anterior repositioning appliance followed by Low level Laser therapy Group4: Low level Laser therapy followed by anterior repositioning appliance
Evaluation was done through the following methods
Clinical examination:
- A detailed questionnaire by the examiner was recorded for each patient including: personal data, chief complaint, medical as well as past dental histories
- Magnetic resonance imaging (MRI) for each patient, the clinical diagnosis of disc displacement with reduction confirmed by MRI.
- Maximum inter-incisal opening (MIO):was measured by Vernier caliper in millimetres (mm) as the vertical distance between the incisal edges of maxillary and mandibular central incisors.
- Range of lateral mandibular excursions was also measured using Vernier caliper in millimetres as the horizontal distance extending from maxillary midline to mandibular midline. This was measured by asking the patient to move the mandible to one side then to the other side to the maximum extent.
- Helkimos clinical dysfunction scale.
Read the detailed description
This study included forty patients suffering from TMJ internal derangement with reduction. They were all selected from the outpatient clinic of the Prosthodontics Department, Faculty of Dentistry, Mansoura University. All the included patients showed persistent restriction of mouth opening as well as TMJ pain and clicking. Patients suffering from inflammatory or connective tissue diseases, neurologic disorders, history of bony or ibrous adhesion, gross mechanical restrictions and condylar fractures, previous TMJ surgery, TMJ ankylosis, or acute infection were all excluded. Moreover, muscle relaxants, non-steroidal anti-inflammatory drugs within 48 h preoperatively, corticosteroid injection at treatment site within one month or systemic use of corticosteroids within 2 weeks were also excluded in this study.
Clinical examination:
- A detailed questionnaire by the examiner was recorded for each patient including: personal data, chief complaint, medical as well as past dental histories
- Magnetic resonance imaging (MRI) for each patient, the clinical diagnosis of disc displacement with reduction was confirmed by MRI.
- Maximum inter-incisal opening (MIO):was measured by Vernier caliper in millimetres (mm) as the vertical distance between the incisal edges of maxillary and mandibular central incisors.
- Range of lateral mandibular excursions was also measured using Vernier caliper in millimetres as the horizontal distance extending from maxillary midline to mandibular midline. This was measured by asking the patient to move the mandible to one side then to the other side to the maximum extent.
- Helkimos clinical dysfunction scale.
Four groups created randomly each 10 patients as following:-
Group 1: anterior repositioning appliance followed by Infra-red LED therapy Group 2: Infra-red LED therapy followed by anterior repositioning appliance Group 3: anterior repositioning appliance followed by Low level Laser therapy Group4: Low level Laser therapy followed by anterior repositioning appliance
Anterior Repositioning Appliance
This appliance, is to alter the maxillomandibular relationship so that a more anterior position assumed by the mandible. Acrylic guiding ramp added to the anterior third of the maxillary appliance that direct the mandible into a more forward position, upon closing. This type of appliance designed to be used in treating patients with anterior disk displacement with reduction. It was supposed that by altering the mandibular position in this manner, the anteriorly displaced disks could return back to its normal position (recaptured).
LOW LEVEL LASER APPLICATION The LLLT were applied bilaterally to the face, five points were irradiated: three points around the TMJ, one point on the temporalis and one on the masseter. The treatment was performed twice a week for three consecutive weeks
INFRA RED LED APPLICATION The LED therapies were applied bilaterally to the face for 60 s/point. Five points were irradiated: three points around the TMJ, one point on the temporalis and one on the masseter. Eight sessions of the phototherapy were performed, twice a week for 4 weeks
Follow up:
Patients were re-examined for maximum openening ,lateral movement and Helkimos scale after 6 months.
- Conditions
- TMJ Disorder
- Being tested
- Photobiomodulation
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhotobiomodulationDevice
Laser therapy using low level laser
| Study group | Role | What they receive |
|---|---|---|
| anterior repositioning appliance followed by Infra-red LED therapy | Experimental | anterior repositioning appliance followed by Infra-red LED therapy Receives: Device: Photobiomodulation |
| Infra-red LED therapy followed by anterior repositioning appliance | Experimental | Infra-red LED therapy followed by anterior repositioning appliance Receives: Device: Photobiomodulation |
| anterior repositioning appliance followed by Low level Laser therapy | Experimental | anterior repositioning appliance followed by Low level Laser therapy Receives: Device: Photobiomodulation |
| Low level Laser therapy followed by anterior repositioning appliance | Experimental | Low level Laser therapy followed by anterior repositioning appliance Receives: Device: Photobiomodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of motion
Maximum opening, lateral movement and protrusion
Measured: Before treatment (T0) , After 6 months (T6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start20 Oct 2022
- Primary completion24 Jun 2023
- Study completion3 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TMJ DisorderStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed shady, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06103110
- Sponsor's protocol ID
- A04100522
- Status last verified
- Oct 2023
- First submitted
- 22 Oct 2023
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Order and Conjugation of Different Photobiomodulation Therapies and Anterior Repositioning Appliance in Management of TMD Cases
- ClinicalTrials.gov ID
- NCT06103110
- Acronym / sponsor ID
- A04100522
- Conditions
- TMJ Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 20 Oct 2022 (actual)
- Primary completion
- 24 Jun 2023 (actual)
- Study completion
- 3 Aug 2023 (actual)
- First posted
- 26 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aimed to evaluate the effect of using Low level laser therapy / Infrared led therapy with anterior repositioning appliance in anterior dislocation patients with reduction (ADDwR) concerning:
- Range of mandibular motion
- Helkimo questioner to evaluate :
A -TMJ function B -Muscle pain C -TMJ pain D - Pain on movement of the mandible
Four groups created randomly each 10 patients as following:-
Group 1: anterior repositioning appliance followed by Infra-red LED therapy Group 2: Infra-red LED therapy followed by anterior repositioning appliance Group 3: anterior repositioning appliance followed by Low level Laser therapy Group4: Low level Laser therapy followed by anterior repositioning appliance
Evaluation was done through the following methods
Clinical examination:
- A detailed questionnaire by the examiner was recorded for each patient including: personal data, chief complaint, medical as well as past dental histories
- Magnetic resonance imaging (MRI) for each patient, the clinical diagnosis of disc displacement with reduction confirmed by MRI.
- Maximum inter-incisal opening (MIO):was measured by Vernier caliper in millimetres (mm) as the vertical distance between the incisal edges of maxillary and mandibular central incisors.
- Range of lateral mandibular excursions was also measured using Vernier caliper in millimetres as the horizontal distance extending from maxillary midline to mandibular midline. This was measured by asking the patient to move the mandible to one side then to the other side to the maximum extent.
- Helkimos clinical dysfunction scale.
Detailed description
This study included forty patients suffering from TMJ internal derangement with reduction. They were all selected from the outpatient clinic of the Prosthodontics Department, Faculty of Dentistry, Mansoura University. All the included patients showed persistent restriction of mouth opening as well as TMJ pain and clicking. Patients suffering from inflammatory or connective tissue diseases, neurologic disorders, history of bony or ibrous adhesion, gross mechanical restrictions and condylar fractures, previous TMJ surgery, TMJ ankylosis, or acute infection were all excluded. Moreover, muscle relaxants, non-steroidal anti-inflammatory drugs within 48 h preoperatively, corticosteroid injection at treatment site within one month or systemic use of corticosteroids within 2 weeks were also excluded in this study.
Clinical examination:
- A detailed questionnaire by the examiner was recorded for each patient including: personal data, chief complaint, medical as well as past dental histories
- Magnetic resonance imaging (MRI) for each patient, the clinical diagnosis of disc displacement with reduction was confirmed by MRI.
- Maximum inter-incisal opening (MIO):was measured by Vernier caliper in millimetres (mm) as the vertical distance between the incisal edges of maxillary and mandibular central incisors.
- Range of lateral mandibular excursions was also measured using Vernier caliper in millimetres as the horizontal distance extending from maxillary midline to mandibular midline. This was measured by asking the patient to move the mandible to one side then to the other side to the maximum extent.
- Helkimos clinical dysfunction scale.
Four groups created randomly each 10 patients as following:-
Group 1: anterior repositioning appliance followed by Infra-red LED therapy Group 2: Infra-red LED therapy followed by anterior repositioning appliance Group 3: anterior repositioning appliance followed by Low level Laser therapy Group4: Low level Laser therapy followed by anterior repositioning appliance
Anterior Repositioning Appliance
This appliance, is to alter the maxillomandibular relationship so that a more anterior position assumed by the mandible. Acrylic guiding ramp added to the anterior third of the maxillary appliance that direct the mandible into a more forward position, upon closing. This type of appliance designed to be used in treating patients with anterior disk displacement with reduction. It was supposed that by altering the mandibular position in this manner, the anteriorly displaced disks could return back to its normal position (recaptured).
LOW LEVEL LASER APPLICATION The LLLT were applied bilaterally to the face, five points were irradiated: three points around the TMJ, one point on the temporalis and one on the masseter. The treatment was performed twice a week for three consecutive weeks
INFRA RED LED APPLICATION The LED therapies were applied bilaterally to the face for 60 s/point. Five points were irradiated: three points around the TMJ, one point on the temporalis and one on the masseter. Eight sessions of the phototherapy were performed, twice a week for 4 weeks
Follow up:
Patients were re-examined for maximum openening ,lateral movement and Helkimos scale after 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| anterior repositioning appliance followed by Infra-red LED therapy | Experimental | Device: Photobiomodulationanterior repositioning appliance followed by Infra-red LED therapy |
| Infra-red LED therapy followed by anterior repositioning appliance | Experimental | Device: PhotobiomodulationInfra-red LED therapy followed by anterior repositioning appliance |
| anterior repositioning appliance followed by Low level Laser therapy | Experimental | Device: Photobiomodulationanterior repositioning appliance followed by Low level Laser therapy |
| Low level Laser therapy followed by anterior repositioning appliance | Experimental | Device: PhotobiomodulationLow level Laser therapy followed by anterior repositioning appliance |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- suffering from TMJ internal derangement with reduction.
- All the included patients show persistent restriction of mouth opening as well as TMJ pain and clicking.
Key exclusion criteria (8 listed)
- Patients suffering from inflammatory or connective tissue diseases,
- neurologic disorders
- history of bony or fibrous adhesion
- gross mechanical restrictions and condylar fractures
- previous TMJ surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhotobiomodulationLaser therapy using low level laser | Device | Infra-red LED therapy followed by anterior repositioning appliance, Low level Laser therapy followed by anterior repositioning appliance, anterior repositioning appliance followed by Infra-red LED therapy, anterior repositioning appliance followed by Low level Laser therapy |
Primary outcome
Range of motion
Time frame: Before treatment (T0) , After 6 months (T6)
Maximum opening, lateral movement and protrusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation in people with TMJ Disorder, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of motion (time frame: Before treatment (T0) , After 6 months (T6)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2023.