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Pain and Comfort During Functional Orthodontic Treatment With Laser or Ultrasounic Waves

StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Study title revised
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07852559
Lead Sponsor Damascus University
Conditions
(from sponsor)		 CLASS II DIVISION 1 MALOCCLUSION
Related terms Malocclusion, Angle Class II
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov