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Low Level Laser Therapy in the Treatment of Temporomandibular Joint Disorders (TMJDs) Related Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03119324
Recruitment Status : Completed
First Posted : April 18, 2017
Last Update Posted : April 18, 2017
Sponsor:
Information provided by (Responsible Party):
Umberto Romeo, University of Roma La Sapienza

Brief Summary:
The Low Level Laser Therapy (LLLT) has been recently introduced with success in the management of the pain associated to this condition. This double blind placebo controlled clinical trial analyzes a new home LLLT protocol to verify whether it was possible to avoid to the repeated presence at dental chair required by traditional LLLT protocols.

Condition or disease Intervention/treatment Phase
Temporomandibular Joint Disorders Device: B-Cure® diode laser Device: B-Cure® diode laser sham device Drug: Nimesulide Ratiopharm® and Flexiban® Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine


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.

Device: B-Cure® diode laser
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 Name: Diode laser

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.

Device: B-Cure® diode laser sham device
B-Cure laser® (Good Energies, Haifa, Israel) application by sham device twice a day for 7 consecutive days
Other Name: Sham device

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

Drug: Nimesulide Ratiopharm® and Flexiban®
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 Name: Drug protocol




Primary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03119324


Sponsors and Collaborators
University of Roma La Sapienza
Investigators
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Principal Investigator: Umberto Romeo, Professor Sapienza University of Rome
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Responsible Party: Umberto Romeo, Associate Professor, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT03119324    
Other Study ID Numbers: URomeo
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: April 18, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Umberto Romeo, University of Roma La Sapienza:
Biomodulation
LLLT
Temporomandibular Joint Disorders
Pain management
Additional relevant MeSH terms:
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Joint Diseases
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Disease
Pathologic Processes
Musculoskeletal Diseases
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes
Nimesulide
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action