Low Level Laser Therapy in the Treatment of Temporomandibular Joint Disorders (TMJDs) Related Pain
NCT03119324 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90
Last updated 2017-04-18
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.
Conditions
- Temporomandibular Joint Disorders
Interventions
- 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
- 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
- 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
Sponsors & Collaborators
-
University of Roma La Sapienza
lead OTHER
Principal Investigators
-
Umberto Romeo, Professor · University of Roma La Sapienza
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-09-30
- Primary Completion
- 2016-06-30
- Completion
- 2017-02-28
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