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

• ClinicalTrials.gov Identifier: NCT03119324
• Recruitment Status: Completed
• First Posted: April 18, 2017
• Last Update Posted: April 18, 2017
• Sponsor: University of Roma La Sapienza
• Information provided by (Responsible Party): Umberto Romeo, University of Roma La Sapienza

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Sponsors and Collaborators

University of Roma La Sapienza

Investigators

• Principal Investigator: Umberto Romeo, Professor; Sapienza University of Rome

More Information

• 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
• Last Update Posted: April 18, 2017
• Last Verified: April 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

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