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Effect of Low-Intensity Pulsed Ultrasound on Functional Treatment of Class II Malocclusion

Effect of Low-Intensity Pulsed Ultrasound Applied on Temporomandibular Joint Region on Functional Treatment of Class II Malocclusion: A Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03251807
Enrollment
40
Registered
2017-08-16
Start date
2017-08-01
Completion date
2019-03-12
Last updated
2019-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malocclusion, Angle Class II

Keywords

Low-intensity pulsed ultrasound, Twin-block, Functional treatment

Brief summary

This experimental study will evaluate the effect of combined treatment with low-intensity pulsed ultrasound (LIPUS) and functional appliances (twin-block) on the correction of class II malocclusion, compared with the control group treated with functional appliances (twin-block) only. The study sample will consist of 40 patients with class II malocclusion. The sample will be allocated randomly into two groups: control group and experimental group. The functional appliance (twin-block) will be applied for all patients, while the low-intensity pulsed ultrasound (LIPUS) will be applied for the experimental group only. The skeleto-dental changes occurring after functional treatment will be assessed using cephalometric radiographs; pre and post- treatment changes for each group will be evaluated individually, and the two groups will be compared.

Detailed description

Studies of the etiologic factors of Class II malocclusions recognize that most Class II malocclusions are a result of mandibular deficiency and not of maxillary excess. For many patients, especially adults, optimal overall results are best obtained using a combined orthodontic-surgical approach. However, treating such cases early while the patient is still growing, using mandibular propulsive functional appliances, can produce satisfactory improvement in the facial esthetics, and minimizes the need for surgical intervention in many cases. Ultrasound (US), a form of mechanical energy that is transmitted through and into biological tissues as an acoustic pressure wave at frequencies above the limit of human hearing, is used widely in medicine as a therapeutic, operative and diagnostic tool. Therapeutic US, and some operative US. Previous studies on animals have found that therapeutic ultrasound (US) can stimulate and enhance mandibular growth when applied during the active growth period. This study will evaluate the effect of low-intensity pulsed ultrasound (LIPUS) on the growth of mandible and the duration of functional treatment. Twin-block will be applied to the two groups. While the control group will receive the twin-block only, the experimental group will receive the twin-block combined with low-intensity pulsed ultrasound (LIPUS) on Temporomandibular joint (TMJ) region. Cephalometric radiographs will be obtained before and after functional treatment to evaluate the dento-skeletal changes.

Interventions

Functional treatment will be achieved using the Twinblock appliance

OTHERLIPUS (Low-intensity pulsed ultrasound)

Functional treatment will be combined with LIPUS (Low-intensity pulsed ultrasound )

Sponsors

Damascus University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
11 Years to 14 Years
Healthy volunteers
No

Inclusion criteria

* Angle class II malocclusion because of mandibular retrognathia * O.J \> 5 , SNB \< 78 * Patient during growth spurt

Exclusion criteria

* TMJ disorders * Poor oral hygiene * Previous orthodontic treatment. * Patients with syndromes, clefts, or craniofacial abnormalities. * Reason of contraindication of functional treatment

Design outcomes

Primary

MeasureTime frameDescription
The duration of functional treatmentAfter functional treatment which will take approximately 8 monthsThe duration of the functional treatment will be measured and compared between groups.

Secondary

MeasureTime frameDescription
Dentoskeletal effects of the functional treatmentChanges will be evaluated before and after functional treatment which will take approximately 8 monthsDentoskeletal changes before and after functional treatment combined with Low-level Laser compared with those of the control group (SNA, SNB, ANB, Overjet ,…etc) using lateral cephalometric radiographs.

Countries

Syria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026