Malocclusion, Angle Class IINCT03251807
Effect of Low-Intensity Pulsed Ultrasound on Functional Treatment of Class II Malocclusion
A study testing Twin-block and LIPUS (Low-intensity pulsed ultrasound) in people with Malocclusion, Angle Class II, run by Damascus University at 1 site in Syria.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 14 years
- Conditions the study is for
- Malocclusion, Angle Class II
- What is being tested?
- Twin-block and LIPUS (Low-intensity pulsed ultrasound)
- 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
- 1 Aug 2017to 12 Mar 2019
- 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 11 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Angle class II malocclusion because of mandibular retrognathia
- O.J > 5 , SNB < 78
- Patient during growth spurt
Who cannot join
- TMJ disorders
- Poor oral hygiene
- Previous orthodontic treatment.
- Patients with syndromes, clefts, or craniofacial abnormalities.
- Reason of contraindication of functional treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Low-Intensity Pulsed Ultrasound Applied on Temporomandibular Joint Region on Functional Treatment of Class II Malocclusion: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Malocclusion, Angle Class II
- Being tested
- Twin-block, LIPUS (Low-intensity pulsed ultrasound)
- Keywords
- Low-intensity pulsed ultrasound, Twin-block, Functional treatment
- 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.
Twin-blockDevice
Functional treatment will be achieved using the Twinblock appliance
LIPUS (Low-intensity pulsed ultrasound)Other
Functional treatment will be combined with LIPUS (Low-intensity pulsed ultrasound )
| Study group | Role | What they receive |
|---|---|---|
| Twin-block | Experimental | The patients in this control group will be treated using the Twin-block appliance. Receives: Device: Twin-block |
| Twin-block combined with LIPUS | Experimental | The patients in this experimental group will be treated using the Twin-block combined with LIPUS (Low-intensity pulsed ultrasound). Receives: Device: Twin-block; Other: LIPUS (Low-intensity pulsed ultrasound) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The duration of functional treatment
The duration of the functional treatment will be measured and compared between groups.
Measured: After functional treatment which will take approximately 8 months
Secondary outcomes (1)
Dentoskeletal effects of the functional treatment
Dentoskeletal 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.
Measured: Changes will be evaluated before and after functional treatment which will take approximately 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2017
- Study start1 Aug 2017
- Primary completion12 Oct 2018
- Study completion12 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Malocclusion, Angle Class IIStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ghiath Mahmood, PhD., Study director, Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03251807
- Sponsor's protocol ID
- UDDS-Ortho-06-2017
- Status last verified
- Jul 2019
- First submitted
- 13 Aug 2017
- Last updated
- 18 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The Individual participant data will be only available for the researchers in the department of Orthodontics, Damascus University
Publications
El-Bialy T, El-Shamy I, Graber TM. Growth modification of the rabbit mandible using therapeutic ultrasound: is it possible to enhance functional appliance results? Angle Orthod. 2003 Dec;73(6):631-9. doi: 10.1043/0003-3219(2003)0732.0.CO;2.
PubMed 14719726El-Bialy T, Hassan A, Albaghdadi T, Fouad HA, Maimani AR. Growth modification of the mandible with ultrasound in baboons: a preliminary report. Am J Orthod Dentofacial Orthop. 2006 Oct;130(4):435.e7-14. doi: 10.1016/j.ajodo.2006.01.025.
PubMed 17045140Flores-Mir C, Major MP, Major PW. Soft tissue changes with fixed functional appliances in Class II division 1. Angle Orthod. 2006 Jul;76(4):712-20. doi: 10.1043/0003-3219(2006)076[0712:STCWFF]2.0.CO;2.
PubMed 16808582Jena AK, Duggal R, Parkash H. Skeletal and dentoalveolar effects of Twin-block and bionator appliances in the treatment of Class II malocclusion: a comparative study. Am J Orthod Dentofacial Orthop. 2006 Nov;130(5):594-602. doi: 10.1016/j.ajodo.2005.02.025.
PubMed 17110256Johns LD, Straub SJ, Howard SM. Analysis of effective radiating area, power, intensity, and field characteristics of ultrasound transducers. Arch Phys Med Rehabil. 2007 Jan;88(1):124-9. doi: 10.1016/j.apmr.2006.09.016.
PubMed 17207688Sun JS, Hong RC, Chang WH, Chen LT, Lin FH, Liu HC. In vitro effects of low-intensity ultrasound stimulation on the bone cells. J Biomed Mater Res. 2001 Dec 5;57(3):449-56. doi: 10.1002/1097-4636(20011205)57:33.0.co;2-0.
PubMed 11523040
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low-Intensity Pulsed Ultrasound Applied on Temporomandibular Joint Region on Functional Treatment of Class II Malocclusion: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03251807
- Acronym / sponsor ID
- UDDS-Ortho-06-2017
- Conditions
- Malocclusion, Angle Class II
- Keywords
- Low-intensity pulsed ultrasound, Twin-block, Functional treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 12 Oct 2018 (actual)
- Study completion
- 12 Mar 2019 (actual)
- First posted
- 16 Aug 2017 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Twin-block | Experimental | Device: Twin-blockThe patients in this control group will be treated using the Twin-block appliance. |
| Twin-block combined with LIPUS | Experimental | Device: Twin-block, Other: LIPUS (Low-intensity pulsed ultrasound)The patients in this experimental group will be treated using the Twin-block combined with LIPUS (Low-intensity pulsed ultrasound). |
Who may qualify
- Ages
- 11 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Angle class II malocclusion because of mandibular retrognathia
- O.J > 5 , SNB < 78
- Patient during growth spurt
Key exclusion criteria (5 listed)
- TMJ disorders
- Poor oral hygiene
- Previous orthodontic treatment.
- Patients with syndromes, clefts, or craniofacial abnormalities.
- Reason of contraindication of functional treatment
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 |
|---|---|---|
| Twin-blockFunctional treatment will be achieved using the Twinblock appliance | Device | Twin-block, Twin-block combined with LIPUS |
| LIPUS (Low-intensity pulsed ultrasound)Functional treatment will be combined with LIPUS (Low-intensity pulsed ultrasound ) | Other | Twin-block combined with LIPUS |
Primary outcome
The duration of functional treatment
Time frame: After functional treatment which will take approximately 8 months
The duration of the functional treatment will be measured and compared between groups.
1 secondary outcome
Dentoskeletal effects of the functional treatment
Time frame: Changes will be evaluated before and after functional treatment which will take approximately 8 months
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 18 Jul 2019.
- Background: PubMed 14719726El-Bialy T, El-Shamy I, Graber TM. Growth modification of the rabbit mandible using therapeutic ultrasound: is it possible to enhance functional appliance results? Angle Orthod. 2003 Dec;73(6):631-9. doi: 10.1043/0003-3219(2003)0732.0.CO;2.
- Background: PubMed 17045140El-Bialy T, Hassan A, Albaghdadi T, Fouad HA, Maimani AR. Growth modification of the mandible with ultrasound in baboons: a preliminary report. Am J Orthod Dentofacial Orthop. 2006 Oct;130(4):435.e7-14. doi: 10.1016/j.ajodo.2006.01.025.
- Background: PubMed 16808582Flores-Mir C, Major MP, Major PW. Soft tissue changes with fixed functional appliances in Class II division 1. Angle Orthod. 2006 Jul;76(4):712-20. doi: 10.1043/0003-3219(2006)076[0712:STCWFF]2.0.CO;2.
- Background: PubMed 17110256Jena AK, Duggal R, Parkash H. Skeletal and dentoalveolar effects of Twin-block and bionator appliances in the treatment of Class II malocclusion: a comparative study. Am J Orthod Dentofacial Orthop. 2006 Nov;130(5):594-602. doi: 10.1016/j.ajodo.2005.02.025.
- Background: PubMed 17207688Johns LD, Straub SJ, Howard SM. Analysis of effective radiating area, power, intensity, and field characteristics of ultrasound transducers. Arch Phys Med Rehabil. 2007 Jan;88(1):124-9. doi: 10.1016/j.apmr.2006.09.016.
- Background: PubMed 11523040Sun JS, Hong RC, Chang WH, Chen LT, Lin FH, Liu HC. In vitro effects of low-intensity ultrasound stimulation on the bone cells. J Biomed Mater Res. 2001 Dec 5;57(3):449-56. doi: 10.1002/1097-4636(20011205)57:33.0.co;2-0.
- Individual participant dataSharing planned: No. The Individual participant data will be only available for the researchers in the department of Orthodontics, Damascus University
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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.
Ghiath Mahmood, PhD. study director
Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Twin-block and LIPUS (Low-intensity pulsed ultrasound) in people with Malocclusion, Angle Class II, 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 3 inclusion and 5 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 18 Jul 2019. 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?
The duration of functional treatment (time frame: After functional treatment which will take approximately 8 months). 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 NCT03251807, which also lists 6 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 18 Jul 2019.