CLASS II DIVISION 1 MALOCCLUSIONNCT07852559
Pain and Comfort During Functional Orthodontic Treatment With Laser or Ultrasounic Waves
A study testing Activator + LIPUS and Activator + LLLT in people with CLASS II DIVISION 1 MALOCCLUSION, run by Damascus University at 1 site in Syria.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 12 years
- Conditions the study is for
- CLASS II DIVISION 1 MALOCCLUSION
- What is being tested?
- Activator + LIPUS and Activator + LLLT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSyria
- Study dates
- 2 Apr 2023to 30 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- History of TMJ trauma
- Radiographic evidence of post- pubertal growth spurt.
- systemic disease affecting growth
Trial locations and contacts
1 site in 1 country.
Syria1 site
Department of Orthodontics, Faculty of Dentistry, University of Damascus
Damascus, Syrian Arab Republic, DM20AM19
About this study
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
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.
Read the detailed description
Functional treatment is a well-established approach for growing patients with skeletal Class II malocclusion, particularly when mandibular retrognathia is the predominant skeletal component. By guiding the mandible into a more advanced position, functional orthopedic appliances aim to improve skeletal and dentoalveolar relationships during the growth period. However, despite their clinical effectiveness, functional appliances may be associated with treatment-related pain, discomfort, and temporary functional limitations, particularly during the early stages of appliance wear. These patient-related experiences may influence appliance acceptance, compliance, and overall satisfaction, making patient-centered outcomes an important component of evaluating functional treatment.
In recent years, non-invasive biophysical modalities such as low-intensity pulsed ultrasound (LIPUS) and low-level laser therapy (LLLT) have attracted increasing attention as adjuncts to orthodontic and functional orthopedic treatment. Both modalities have been investigated because of their potential biological effects, including modulation of inflammatory responses, enhancement of tissue repair, and reduction of treatment-associated pain and discomfort. Previous randomized clinical trials have reported that combining LIPUS or LLLT with functional orthopedic therapy may improve treatment-related skeletal and dentoalveolar outcomes and potentially reduce overall treatment duration. However, these studies have primarily focused on skeletal, dental, and treatment-duration outcomes, while the patient's experience during functional treatment has received considerably less attention.
This randomized clinical trial will be conducted at the Department of Orthodontics, Faculty of Dentistry, Damascus University. Forty growing patients with skeletal Class II Division 1 malocclusion will be randomly allocated equally to one of two treatment groups: a low-intensity pulsed ultrasound-assisted Modified Schmuth Activator group (LIPUS-Act) or a low-level laser therapy-assisted Modified Schmuth Activator group (LLLT-Act). The Modified Schmuth Activator will be standardized for all participants and will be fabricated using the same general design and construction protocol. The appliance will consist of an acrylic body with upper and lower splints, labial bows, a Coffin spring, and an acrylic cap for retention of the lower incisors. A standardized construction bite will be recorded using a single-step mandibular advancement with a vertical opening of 5-6 mm in the premolar region. Patients will be instructed to wear the appliance for 18 hours per day under parental supervision. The active treatment phase will be considered complete when a Class I molar relationship, normal overjet and overbite, and absence of posterior chin displacement are achieved.
The two treatment groups will differ only in the adjunctive biophysical intervention applied during functional therapy. In the LIPUS-Act group, LIPUS will be used as the adjunctive intervention, whereas LLLT will be used in the LLLT-Act group. Both adjunctive interventions will follow the same treatment schedule: twice weekly during the first month, once every two weeks during the second month, and once every three weeks thereafter until completion of active treatment.
Rather than evaluating treatment solely according to clinical or skeletal outcomes, the present study will specifically focus on the patient's experience during functional orthopedic therapy. Patient-reported outcomes will be assessed using a structured questionnaire adapted from previously developed instruments and converted to a Visual Analog Scale (VAS) format to allow quantitative assessment of symptom intensity. Five patient-centered domains will be evaluated: soft-tissue tension, muscle pain, temporomandibular joint pain, difficulty in mouth opening, and overall treatment satisfaction.
The primary purpose of this study will be to directly compare LIPUS and LLLT as adjuncts to functional orthopedic treatment with regard to patient-centered experiences during treatment. Particular attention will be given to the early treatment period, when discomfort and functional adaptation may be most pronounced, as well as to the subsequent changes in treatment-related symptoms and patient satisfaction throughout the follow-up period.
- Conditions
- CLASS II DIVISION 1 MALOCCLUSION
- Being tested
- Activator + LIPUS, Activator + LLLT
- Medical subject headings
- Malocclusion, Angle Class II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activator + LIPUSDevice
- 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 + LLLTDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Functional treatment + LIPUS | Experimental | Participants will be treated using the Modified Schmuth Activator with low-intensity pulsed ultrasound Receives: Device: Activator + LIPUS |
| Functional treatment + LLLT | Active comparator | Participants will be treated using the Modified Schmuth Activator with low-level laser therapy Receives: Device: Activator + LLLT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start2 Apr 2023
- Primary completion30 Dec 2023
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for CLASS II DIVISION 1 MALOCCLUSIONStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dima M. Almrayati, DDS, MSc, Principal investigator, Damascus UniversityMohammad Y. Hajeer, DDS, MSc, PhD, Study director, Damascus UniversityWael Almahdi, DDS, MSc, PhD, Study director, Damascus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07852559
- Sponsor's protocol ID
- UDDS-2026-Ortho-05
- Status last verified
- Oct 2026
- First submitted
- 25 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41822256Alsilq 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.
PubMed 39805909Abdulhadi 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.
PubMed 35345811Namera 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.
PubMed 32307933Almasri 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.
PubMed 39055972
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07852559
- Acronym / sponsor ID
- UDDS-2026-Ortho-05
- Conditions
- CLASS II DIVISION 1 MALOCCLUSION
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 2 Apr 2023 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 1 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Functional treatment is a well-established approach for growing patients with skeletal Class II malocclusion, particularly when mandibular retrognathia is the predominant skeletal component. By guiding the mandible into a more advanced position, functional orthopedic appliances aim to improve skeletal and dentoalveolar relationships during the growth period. However, despite their clinical effectiveness, functional appliances may be associated with treatment-related pain, discomfort, and temporary functional limitations, particularly during the early stages of appliance wear. These patient-related experiences may influence appliance acceptance, compliance, and overall satisfaction, making patient-centered outcomes an important component of evaluating functional treatment.
In recent years, non-invasive biophysical modalities such as low-intensity pulsed ultrasound (LIPUS) and low-level laser therapy (LLLT) have attracted increasing attention as adjuncts to orthodontic and functional orthopedic treatment. Both modalities have been investigated because of their potential biological effects, including modulation of inflammatory responses, enhancement of tissue repair, and reduction of treatment-associated pain and discomfort. Previous randomized clinical trials have reported that combining LIPUS or LLLT with functional orthopedic therapy may improve treatment-related skeletal and dentoalveolar outcomes and potentially reduce overall treatment duration. However, these studies have primarily focused on skeletal, dental, and treatment-duration outcomes, while the patient's experience during functional treatment has received considerably less attention.
This randomized clinical trial will be conducted at the Department of Orthodontics, Faculty of Dentistry, Damascus University. Forty growing patients with skeletal Class II Division 1 malocclusion will be randomly allocated equally to one of two treatment groups: a low-intensity pulsed ultrasound-assisted Modified Schmuth Activator group (LIPUS-Act) or a low-level laser therapy-assisted Modified Schmuth Activator group (LLLT-Act). The Modified Schmuth Activator will be standardized for all participants and will be fabricated using the same general design and construction protocol. The appliance will consist of an acrylic body with upper and lower splints, labial bows, a Coffin spring, and an acrylic cap for retention of the lower incisors. A standardized construction bite will be recorded using a single-step mandibular advancement with a vertical opening of 5-6 mm in the premolar region. Patients will be instructed to wear the appliance for 18 hours per day under parental supervision. The active treatment phase will be considered complete when a Class I molar relationship, normal overjet and overbite, and absence of posterior chin displacement are achieved.
The two treatment groups will differ only in the adjunctive biophysical intervention applied during functional therapy. In the LIPUS-Act group, LIPUS will be used as the adjunctive intervention, whereas LLLT will be used in the LLLT-Act group. Both adjunctive interventions will follow the same treatment schedule: twice weekly during the first month, once every two weeks during the second month, and once every three weeks thereafter until completion of active treatment.
Rather than evaluating treatment solely according to clinical or skeletal outcomes, the present study will specifically focus on the patient's experience during functional orthopedic therapy. Patient-reported outcomes will be assessed using a structured questionnaire adapted from previously developed instruments and converted to a Visual Analog Scale (VAS) format to allow quantitative assessment of symptom intensity. Five patient-centered domains will be evaluated: soft-tissue tension, muscle pain, temporomandibular joint pain, difficulty in mouth opening, and overall treatment satisfaction.
The primary purpose of this study will be to directly compare LIPUS and LLLT as adjuncts to functional orthopedic treatment with regard to patient-centered experiences during treatment. Particular attention will be given to the early treatment period, when discomfort and functional adaptation may be most pronounced, as well as to the subsequent changes in treatment-related symptoms and patient satisfaction throughout the follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional treatment + LIPUS | Experimental | Device: Activator + LIPUSParticipants will be treated using the Modified Schmuth Activator with low-intensity pulsed ultrasound |
| Functional treatment + LLLT | Active comparator | Device: Activator + LLLTParticipants will be treated using the Modified Schmuth Activator with low-level laser therapy |
Who may qualify
- Ages
- 10 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- History of TMJ trauma
- Radiographic evidence of post- pubertal growth spurt.
- systemic disease affecting growth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Functional treatment + LIPUS |
| Activator + LLLTIn 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. | Device | Functional treatment + LLLT |
Primary outcome
Change in the levels of soft tissue tension
Time frame: 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.
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).
Change in the levels of muscle pain
Time frame: 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.
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).
Change in the levels of TMJ pain
Time frame: 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.
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).
Change in the levels of difficulties in mouth opening.
Time frame: 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
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).
Change in the levels of satisfaction.
Time frame: 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.
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Background: PubMed 41822256Almrayati 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.
- Background: PubMed 39805909Alsilq 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.
- Background: PubMed 35345811Abdulhadi 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.
- Background: PubMed 32307933Namera 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.
- Background: PubMed 39055972Almasri 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dima M. Almrayati, DDS, MSc principal investigator
Damascus University
Mohammad Y. Hajeer, DDS, MSc, PhD study director
Damascus University
Wael Almahdi, DDS, MSc, PhD study director
Damascus University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activator + LIPUS and Activator + LLLT in people with CLASS II DIVISION 1 MALOCCLUSION, run by Damascus University at 1 site in Syria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the levels of soft tissue tension (time frame: 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.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07852559, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.