- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03119324
Low Level Laser Therapy in the Treatment of Temporomandibular Joint Disorders (TMJDs) Related Pain
Evaluation of the Efficacy of a New Low Level Laser Therapy (LLLT) Home Protocol in the Treatment of the Temporomandibular Joint Disorders Related Pain. A Randomized, Double Blind Placebo Controlled Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
90 patients with pain deriving from mono- or bi-lateral TMJDs were enrolled in the study. Randomly subdivided in 3 groups. The Study Group (SG n=30) receive a LLLT by the B-cure Dental Pro 808nm diode low level laser (Biocare Enterprise Ltd, Good Energies, Haifa, IL). The therapeutic protocol previews 2 applications a day for 7 consecutive days performed at 5 Joules/min, 250 milliWatts and 15 KiloHertz for 8', (40 Joules total each) in contact mode over the painful area.
The first application is performed at the Department of Oral Sciences of Sapienza University of Rome, by a laser expert blinded examiner and serves as instruction. The remnants applications must be performed at home by the patients themselves.
The Placebo Group (PG n=30) follows the same protocol by a sham device, seemingly identical to the effective ones, including the pointer light, but devoid of the main diode source.
The Drug Control Group (DG n=30) follows the conventional drug treatment for TMJDs related pain, 2 non-consecutive cycles of 5 days of nimesulide (100mg a day), interspersed with one 5 days cycle of cyclobenzaprine hydrochloride (10 mg a day) Two pain evaluation are registered, before and after treatment.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- TMJD diagnosed clinically and by CT and MRI; presence of pain in the TMJ area or radiating to the face, jaw, or neck; reduced mouth opening or jaw locks, painful clicking, popping or grating when opening or closing mouth, occlusal alterations
Exclusion Criteria:
- Muscle tenderness; NSAIDs assumption within 3 weeks before the treatment; pregnancy; neurocognitive diseases; autoimmune diseases; connective diseases
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: B-Cure® diode laser
Thirty patients receiving LLLT by the B-Cure® diode laser (Good Energies, Haifa, Israel) 808nm low power device at 5 Joules/min, 250 milliWatts 15 KiloHertz for 8', (40 Joules each) in contact mode directly over the painful area, twice a day for 7 consecutive days. The laser must be placed directly over the painful area, after having cleaned it with a soft cotton socket to remove skin impurities that could interfere with therapeutic light absorption. The first application is performed at the Department of Oral Sciences of Sapienza University of Rome by a laser expert investigator and serves as instruction. The remnants must be performed by the patients themselves at home, once on the first day and twice a day in the following 6 days. Patients were instructed to perform the applications always at the same time. |
B-Cure laser® (Good Energies, Haifa, Israel) 808nm diode laser application in contact mode over painful area twice a day for 7 consecutive days
Other Names:
|
Placebo Comparator: B-Cure® diode laser sham device
Thirty patients that follows the same protocol of the SG but receive a B-Cure laser® sham device, seemingly identical to the effective one but devoid of main diode source. The laser must be placed directly over the painful area, after having cleaned it with a soft cotton socket to remove skin impurities that could interfere with therapeutic light absorption. The first application is performed at the Department of Oral Sciences of Sapienza University of Rome by a laser expert investigator and serves as instruction. The remnants must be performed by the patients themselves at home, once on the first day and twice a day in the following 6 days. Patients were instructed to perform the applications always at the same time. |
B-Cure laser® (Good Energies, Haifa, Israel) application by sham device twice a day for 7 consecutive days
Other Names:
|
Active Comparator: Nimesulide Ratiopharm® and Flexiban®
Thirty patients follows the conventional drug therapy protocol, of two non-consecutive cycles of 5 days of Non Steroidal Anti Inflammatory drug, Nimesulide Ratiopharm® (100 mg a day), interspersed with one 5 days cycle of Myorelaxant, Flexiban® (10 mg a day). From day 1 to 5, patients assumed 50mg of Nimesulide Ratiopharm®, twice a day; from 6th to 10th day they assumed 10mg of Flexiban® in single dose, from day 11 to 15 they assumed 50mg of Nimesulide Ratiopharm® twice a day. Patients were instructed to assume the therapy always at the same time |
Five consecutive days assumption of Non Steroidal Anti Inflammatory drug, Nimesulide Ratiopharm® 50mg twice a day, followed by five consecutive days assumption of Myorelaxant, Flexiban®, 10mg once a day, followed by five consecutive days assumption of 50mg of Non Steroidal Anti Inflammatory drug, Nimesulide Ratiopharm®, twice a day
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain reduction laser groups
Time Frame: 7 days
|
Pain assessment by the visual analogue scale (VAS) from Baseline, at day 1 before the treatment, and at day 7, after one week of laser protocol
|
7 days
|
Pain reduction drug control
Time Frame: 15 days
|
Pain assessment by the visual analogue scale (VAS) from Baseline, at day 1 before the treatment and at day 15, after two weeks of drug assumption
|
15 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Umberto Romeo, Professor, Sapienza University of Rome
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
- Pathologic Processes
- Musculoskeletal Diseases
- Muscular Diseases
- Stomatognathic Diseases
- Jaw Diseases
- Craniomandibular Disorders
- Mandibular Diseases
- Myofascial Pain Syndromes
- Disease
- Joint Diseases
- Temporomandibular Joint Disorders
- Temporomandibular Joint Dysfunction Syndrome
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Nimesulide
Other Study ID Numbers
- URomeo
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
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