- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07588841
Evaluation of Low Energy Level Laser Biostimulation at Different Energy Densities in the Treatment of Temporomandibular Joint Irregularities: A Retrospective Study
The Study Was Conducted by Retrospectively Analysing the Files of Patients Who Presented With Temporomandibular Joint Disorder (TMD) and Underwent LLEL Treatment. Patients Were Divided Into Myalgia, Disc Displacement With Reduction and Follow-up Groups. In Our Study, GaAl-As Diode Laser (EzLase 940, Biolase Technology, Inc. 4 Cromwell Irvine, USA) for Lowlevel Laser Treatment Was Applied for 1 Minute to Subgroup 1 (940 nm, 1. 5 W, 90 J, Continuous), Subgroup 2 (940 nm, 3 W, 180J, Continuous) and Subgroup 1 (940 nm, 1.5 W, 90J, Continuous) and Subgroup 2 (940 nm, 3 W, 180J, Continuous).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Trabzon
-
Trabzon, Trabzon, Turkey (Türkiye), 61000
- Karadeniz Technical University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Diagnosis of disc displacement with reduction (DDwR) and myalgia according to DC/TMD criteria Presence of temporomandibular joint pain and functional limitation Patients aged 18 years and older No previous temporomandibular joint (TMJ) treatment Absence of systemic diseases Willingness to participate and provide informed consent
Exclusion Criteria:
History of previous TMJ treatment (e.g., conservative or surgical treatment) Congenital or inflammatory joint disease Severe systemic diseases Edentulous patients Children and adolescents in the active growth period Acute trauma history involving the TMJ region Inability or unwillingness to complete follow-up visits
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Low Level Laser Therapy
Participants in this group received low-level laser therapy applied to the temporomandibular joint region according to the predefined treatment protocol.
Laser therapy was administered for 2 minutes per joint over 9 treatment sessions.
Patients were also advised to follow a soft diet during the treatment period.
|
Participants received low-level laser therapy applied to the temporomandibular joint region in addition to soft diet recommendations.
Treatment was performed in 9 sessions according to the predefined laser protocol.
Participants followed a soft diet regimen without receiving laser therapy and served as the comparison group.
|
|
Other: soft diet group
Soft Diet Group: Participants in this group did not receive laser therapy and were instructed to follow a soft diet during the study period. This group served as the comparison group for evaluating treatment outcomes. |
Participants in this group did not receive laser therapy and were instructed to follow a soft diet during the study period.
This group served as the comparison group for evaluating treatment outcomes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in temporomandibular pain intensity measured by the Visual Analog Scale (VAS) from baseline to the end of treatment and follow-up
Time Frame: 6 month
|
Change in temporomandibular pain intensity was assessed using the Visual Analog Scale (VAS) from baseline to the end of treatment and follow-up.
The Visual Analog Scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable.
Higher scores represent greater pain severity.
|
6 month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 64529847/7
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Myalgia of Mastication Muscle
-
Universidad Nacional Andres BelloCompletedMyalgia of Mastication MuscleChile
-
Universidad Nacional Andres BelloCompletedMyalgia of Mastication Muscle
-
Urbano Santana PeninRecruitingTemporomandibular Disorders (TMD) | Myalgia of Mastication Muscle | Arthralgia SyndromeSpain
-
Diakonessenhuis, UtrechtFysiotherapie Utrecht Oost B.V.Enrolling by invitationMyalgia of Mastication Muscle | TMD/Orofacial Pain | Botulinum Toxin, Type aNetherlands
-
Michigan State UniversityCompletedFocus of Study is to Determine Efficacy of CompexUnited States
-
University of SurreyCompletedMuscle Soreness | Muscle Strength | Muscle DamageUnited Kingdom
-
Indonesia UniversityCompletedMuscle Soreness | Stiffness of Elbow, Not Elsewhere ClassifiedIndonesia
-
KU LeuvenCompletedMuscle Soreness | Muscle RecoveryBelgium
-
Naturex SAAtlantia Food Clinical TrialsCompletedPain | Muscle Soreness | Muscle DamageIreland
-
Richard Deichmann, MDCompletedMyalgia | Muscle Weakness | Side Effects of StatinsUnited States
Clinical Trials on Low Level Laser Therapy
-
Universidade Federal de Sao CarlosConselho Nacional de Desenvolvimento Científico e TecnológicoCompleted
-
Cairo UniversityNot yet recruitingNeuropathic Pain | Neck Disease, Head and Neck Cancer
-
University of BergenCompleted
-
University of BergenNorwegian Fund for Postgraduate Training in PhysiotherapyCompleted
-
University of Nove de JulhoSimone Aparecida Penimpedo Calamita; Fabiana Sarilho de Mendonça; Daniela Aparecida... and other collaboratorsCompleted
-
St. Elisabethen Krankenhaus Frankfurt GmbHRecruitingSurgical Scar Tissue of Cesarean Section or Vaginal Tear or EpisiotomyGermany
-
University of LahoreCompletedNeck Pain | Myofacial Trigger Points | Myofascial Pain Syndrome (MPS)Pakistan
-
Universidade Federal de Sao CarlosFundação de Amparo à Pesquisa do Estado de São Paulo; Faculty of Medicine of... and other collaboratorsCompleted
-
Cairo UniversityNot yet recruitingMyofascial Pain Dysfunction SyndromeEgypt
-
University of OttawaBioFlexTM Laser TherapyCompletedProvoked VestibulodyniaCanada