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

NCT07852559 | Completed DMC

• 1 other identifier: UDDS-2026-Ortho-05
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

CLASS II DIVISION 1 MALOCCLUSION

Outcome Measures

Primary Outcomes (5)

• Change in the levels of soft tissue tension

  Assessment will be performed using questionnaires via the Visual Analog scale (VAS). The Visual Analog Scale is a 100 mm horizontal line with two focal points at its beginning and end (0: no tension - 100: the worst tension).

  Time 1: 1 week after the insertion of the appliance; Time 2: 2 weeks; Time 3: 6 weeks; Time 4: 3 months; Time 5: 6 months following the treatment initiation.

• Change in the levels of muscle pain

  Assessment will be performed using questionnaires via the Visual Analog Scale (VAS). The Visual Analog Scale is a 100 mm horizontal line with two focal points at its beginning and end (0: no pain - 100: the worst pain).

  Time 1: 1 week after after the insertion of the appliance; Time 2: 2 weeks; Time 3: 6 weeks; Time 4: 3 months; Time 5: 6 months following the treatment initiation.

• Change in the levels of TMJ pain

  Assessment will be performed using questionnaires via the Visual Analog Scale (VAS). The Visual Analog Scale is a 100 mm horizontal line with two focal points at its beginning and end (0: no pain - 100: the worst pain).

  Time 1: 1 week after the insertion of the appliance; Time 2: 2 weeks; Time 3: 6 weeks; Time 4: 3 months; Time 5: 6 months following the treatment initiation.

• Change in the levels of difficulties in mouth opening.

  Assessment will be performed using questionnaires via the Visual Analog Scale (VAS). The Visual Analog Scale is a 100 mm horizontal line with two focal points at its beginning and end (0: no difficulties - 100: the worst difficulties).

  Time 1: 1 week after the insertion of the appliance; Time 2: 2 weeks; Time 3: 6 weeks; Time 4: 3 months; Time 5: 6 months following the treatment initiation

• Change in the levels of satisfaction.

  Assessment will be performed using questionnaires via the Visual Analog Scale (VAS). The Visual Analog Scale is a 100 mm horizontal line with two focal points at its beginning and end (0: no satisfaction - 100: the highest satisfaction).

  Time 1: 1 week after the insertion of the appliance; Time 2: 2 weeks; Time 3: 6 weeks; Time 4: 3 months; Time 5: 6 months following the treatment initiation.

Study Arms (2)

Functional treatment + LIPUS

EXPERIMENTAL

Participants will be treated using the Modified Schmuth Activator with low-intensity pulsed ultrasound

Device: Activator + LIPUS

Functional treatment + LLLT

ACTIVE COMPARATOR

Participants will be treated using the Modified Schmuth Activator with low-level laser therapy

Device: Activator + LLLT

Interventions

Activator + LIPUS DEVICE

• 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.

Functional treatment + LIPUS

Activator + LLLT DEVICE

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.

Functional treatment + LLLT

Eligibility Criteria

• Age: 10 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Skeletal Class II Division 1 malocclusion with an ANB angle greater than 5°.
• Overjet exceeding 4 mm.
• Normal lower incisor inclination.
• Horizontal or average facial growth pattern.
• No previous orthodontic treatment.
• Evidence of a pubertal growth spurt at treatment initiation, as assessed by hand-wrist radiographs.

You may not qualify if:

• History of TMJ trauma
• Radiographic evidence of post- pubertal growth spurt.
• systemic disease affecting growth

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Department of Orthodontics, Faculty of Dentistry, University of Damascus

Damascus, Syrian Arab Republic, DM20AM19, Syria

Location

Related Publications (5)

• Almrayati DM, Hajeer MY, Burhan AS, Almahdi WH, Jaber ST. A Novel Protocol to Accelerate Functional Orthopedic Treatment Using Low-Intensity Pulsed Ultrasound in Patients With Skeletal Class II Malocclusion: A Preliminary Clinical Report. Cureus. 2026 Mar 11;18(3):e105067. doi: 10.7759/cureus.105067. eCollection 2026 Mar.

  PMID: 41822256 BACKGROUND

• Alsilq MN, Youssef M. Dentoskeletal effects of aesthetic and conventional twin block appliances in the treatment of skeletal class II malocclusion: a randomized controlled trial. Sci Rep. 2025 Jan 13;15(1):1879. doi: 10.1038/s41598-025-86219-0.

  PMID: 39805909 BACKGROUND

• Abdulhadi A, Burhan AS, Hajeer MY, Hamadah O, Mahmoud G, Nawaya FR, Namera MO. Evaluation of the Functional Treatment of Patients With Skeletal Class II Malocclusion Using Low-Level Laser Therapy-Assisted Twin-Block Appliance: A Three-Arm Randomized Controlled Trial. Cureus. 2022 Mar 24;14(3):e23449. doi: 10.7759/cureus.23449. eCollection 2022 Mar.

  PMID: 35345811 BACKGROUND

• Namera MO, Mahmoud G, Abdulhadi A, Burhan A. Effects of low-intensity pulsed ultrasound (LIPUS) applied on the temporomandibular joint (TMJ) region on the functional treatment of class II malocclusion: A randomized controlled trial. Dent Med Probl. 2020 Jan-Mar;57(1):53-60. doi: 10.17219/dmp/112321.

  PMID: 32307933 BACKGROUND

• Almasri AMH, Hajeer MY, Ajaj MA, Almusawi AOA, Jaber ST, Zakaria AS, Alam MK. Patient Satisfaction Following Orthodontic Treatment: A Systematic Review. Cureus. 2024 Jul 25;16(7):e65339. doi: 10.7759/cureus.65339. eCollection 2024 Jul.

  PMID: 39055972 BACKGROUND

MeSH Terms

Conditions

Malocclusion, Angle Class II

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Dima M. Almrayati, DDS, MSc

  Damascus University

  PRINCIPAL INVESTIGATOR

• Mohammad Y. Hajeer, DDS, MSc, PhD

  Damascus University

  STUDY DIRECTOR

• Wael Almahdi, DDS, MSc, PhD

  Damascus University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2026
• First Posted: October 1, 2026
• Study Start: April 2, 2023
• Primary Completion: December 30, 2023
• Study Completion: January 30, 2024
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)