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Pain and Comfort During Functional Orthodontic Treatment With Laser or Ultrasounic Waves
Sponsor: Damascus University
Summary
Pain, discomfort, and functional limitations are common during functional orthodontic treatment and may affect appliance acceptance, compliance, and treatment satisfaction. This randomized clinical trial will compare patient-reported outcomes associated with low-intensity pulsed ultrasound (LIPUS) and low-level laser therapy (LLLT) as adjuncts to functional orthopedic treatment of skeletal Class II malocclusion. Forty growing patients with skeletal Class II Division 1 malocclusion will be randomly allocated to a LIPUS-assisted Modified Schmuth Activator group or an LLLT-assisted Modified Schmuth Activator group, with 20 patients in each group. All patients will be treated using a standardized Modified Schmuth Activator, which will be worn for 18 hours per day. LIPUS will be applied bilaterally over the temporomandibular joint regions, whereas LLLT will be administered to five points around the condylar region on each side. Patient-reported outcomes will be assessed using a Visual Analog Scale questionnaire evaluating soft-tissue tension, muscle pain, temporomandibular joint pain, difficulty in mouth opening, and overall satisfaction. Assessments will be performed at 7 days, 14 days, 6 weeks, 3 months, and 6 months after appliance insertion.
Official title: Patient-Reported Outcomes During Functional Treatment of Skeletal Class II Malocclusion With Low-Level Laser Versus Low-Intensity Pulsed Ultrasound: A Randomized Non-controlled Clinical Trial
Key Details
Gender
All
Age Range
10 Years - 12 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2023-04-02
Completion Date
2024-01-30
Last Updated
2026-10-05
Healthy Volunteers
No
Conditions
Interventions
Activator + LIPUS
• In this group, low-intensity pulsed ultrasound (LIPUS) will be applied bilaterally to the temporomandibular joint (TMJ) region using the US PRO 2000™ 2nd Edition device. The device will generate 200-µs bursts of a 1-MHz sine wave at a pulse repetition frequency of 100 Hz, with a temporal average intensity of 0.03 W/cm². LIPUS will be administered twice weekly during the first month, once every two weeks during the second month, and subsequently once every three weeks until completion of active treatment. All sessions will be performed by the principal investigator to ensure consistency of the treatment protocol.
Activator + LLLT
In this group, low-level laser therapy (LLLT) will be applied bilaterally around the condylar region using the Mercury™ laser device, with a power output of 0.20 W and a wavelength of 810 nm. The laser will be applied to five points on each side: the anterior, superior, inferior, and posterior regions of the condyle, as well as along the external auditory canal. Each point will receive 4 J of laser energy for 20 seconds. LLLT will be administered according to the same treatment schedule as LIPUS: twice weekly during the first month, once every two weeks during the second month, and subsequently once every three weeks until completion of active treatment.
Locations (1)
Department of Orthodontics, Faculty of Dentistry, University of Damascus
Damascus, Syrian Arab Republic, Syria