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
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.
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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