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

Temporomandibular Joint Disorders Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03119324
• Other study ID #: URomeo
• Status: Completed
• Phase: N/A
• First received: March 3, 2017
• Last updated: April 13, 2017
• Start date: September 2015
• Est. completion date: February 2017

Study information

• Verified date: April 2017
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: February 2017
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Joint Diseases
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

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

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain reduction laser groups	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
Primary	Pain reduction drug control	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