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

April 13, 2017 updated by: Umberto Romeo, University of Roma La Sapienza

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

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.

Study Overview

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

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • 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.

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

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:
  • Drug protocol

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

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

March 3, 2017

First Submitted That Met QC Criteria

April 13, 2017

First Posted (Actual)

April 18, 2017

Study Record Updates

Last Update Posted (Actual)

April 18, 2017

Last Update Submitted That Met QC Criteria

April 13, 2017

Last Verified

April 1, 2017

More Information

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 Temporomandibular Joint Disorders

Clinical Trials on B-Cure® diode laser

Subscribe