Effects of Low-Level Laser Therapy on Mouth Opening and Surface Electromyography in Temporomandibular Disorders
NCT ID: NCT04831346
Last Updated: 2024-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2020-11-01
2025-02-01
Brief Summary
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Detailed Description
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Outcome measures: TMJ opening index (TOI), VAS, sEMG. Participants were not given information on which treatment they were receiving; they were only told that they could receive one of two different treatment techniques. Sessions were scheduled 3 days a week (every other day) for a total of 10 sessions
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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low level laser
A low-level gallium arsenide diode (Biolase, USA) at a 940 nm wavelength with 0.2 W output power and 2 J energy. The device was calibrated, and the probe was disinfected prior to every treatment.
The Masseter and Temporalis muscles will be bilaterally assessed with constant pressure to define tenderness.
LLLT applied perpendicular to each tender point of the intended muscles for 10 seconds with an energy density of 2.5 J/cm2.
Sessions are scheduled 3 days a week (every other day)
Low level laser
940 nm wavelength with 0.2 W output power and 2 J energy applied for 10 seconds with an energy density of 2.5 J/cm2.
Occlusive splint therapy
A soft occlusal splint (vacuum-formed ) made from a 2-mm-thick elastic rubber sheets will be used.
Splints were individually designed ( in the out patient clinic of the college of dentistry) for the upper arch of each patient. An alginate imprint of the maxillary arch will be taken to fabricate a master cast of the maxilla.
A vacuum pressure device was utilized for molding the rubber sheets (13 x 13 cm /2-mm thickness).
Sheets were removed after it has been appropriately adjusted to the mold in the vacuum former. Edges will be properly trimmed, and the palate part is detached to obtain the end shape.
Participants are instructed to wear the splint at all times except during mealtimes and oral hygiene.
Soft occlusive splint
A vacuum-formed soft occlusal splint made from a 2-mm-thick elastic rubber sheets.
Participants are instructed to always wear the splint except during mealtimes and oral hygiene.
Control
This group will be a wait list group recieving no intervention except for the regular analgesic prescribed by the reffering dentist
No interventions assigned to this group
Interventions
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Low level laser
940 nm wavelength with 0.2 W output power and 2 J energy applied for 10 seconds with an energy density of 2.5 J/cm2.
Soft occlusive splint
A vacuum-formed soft occlusal splint made from a 2-mm-thick elastic rubber sheets.
Participants are instructed to always wear the splint except during mealtimes and oral hygiene.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
30 Years
FEMALE
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Tamer Mohamed Shousha
Lecturer
Principal Investigators
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Tamer Shousha
Role: PRINCIPAL_INVESTIGATOR
Lecturer
Locations
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Faculty of Physical Therapy
Giza, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CairoU2020
Identifier Type: -
Identifier Source: org_study_id
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