Malocclusion, Angle Class IINCT03239912
Treatment of Class II Malocclusion Combined With Low-level Laser
A study testing Twin-block appliance and Low level laser 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-level laser 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 appliance and Low level laser
- 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
- 16 Jul 2017to 15 Feb 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
- Skeletal Class II malocclusion because of mandibular retrognathia
- ANB > 4
- Overjet > 5
- SNB < 78
Who cannot join
- 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: The Effects of Combined Treatment With Low-level Laser and Functional Appliances on the Correction of Class II Malocclusion: A Randomized Controlled Trial
This experimental study will evaluate the effect of combined treatment with low-level laser 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: a control group and an experimental group.
Functional appliance (twin-block) will be applied for all patients. Low-level laser 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.
Read the detailed description
Class II malocclusion is considered as the most common malocclusion between patients.
Recently low-level laser enters the world of dentistry, some studies assessed the effect of low-level laser on the growth of mandibles and condyles in animals and showed that there is a good effect of laser on the mandible growth.
This study will evaluate the effect of low-level laser on the growth of the mandible and the duration of functional treatment.
Twin-block will be applied in two groups: The control group will receive the twin-block only, and the experimental group will receive the twin-block combined with low-level laser therapy on the TMG region.
Cephalometric radiographs will be gotten before and after functional treatment to evaluate the dento-skeletal changes.
- Conditions
- Malocclusion, Angle Class II
- Being tested
- Twin-block appliance, Low level laser
- Keywords
- Low-level laser, functional treatment, twin-block, RCT
- 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-block applianceDevice
Functional treatment will be achieved using the Twin-block appliance
Low level laserOther
Functional treatment will be combined with low-level laser therapy on the TMG region
| Study group | Role | What they receive |
|---|---|---|
| Twin-block group | Experimental | Functional treatment will be applied using the Twin-block appliance. Receives: Device: Twin-block appliance |
| Twin-block combined with low level laser | Experimental | Functional treatment will be applied using the Twin-block appliance combined with low level laser. Receives: Device: Twin-block appliance; Other: Low level laser |
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 posted4 Aug 2017
- Study start16 Jul 2017
- Primary completion15 Oct 2018
- Study completion15 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Ahmad S Burhan, PhD., Study chair, Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03239912
- Sponsor's protocol ID
- UDDS-Ortho-05-2017
- Status last verified
- Jul 2019
- First submitted
- 28 Jul 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
Abtahi M, Poosti M, Saghravanian N, Sadeghi K, Shafaee H. The effect of low level laser on condylar growth during mandibular advancement in rabbits. Head Face Med. 2012 Feb 23;8:4. doi: 10.1186/1746-160X-8-4.
PubMed 22361310Angeletti P, Pereira MD, Gomes HC, Hino CT, Ferreira LM. Effect of low-level laser therapy (GaAlAs) on bone regeneration in midpalatal anterior suture after surgically assisted rapid maxillary expansion. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2010 Mar;109(3):e38-46. doi: 10.1016/j.tripleo.2009.10.043.
PubMed 20219584Oksayan R, Sokucu O, Ucuncu N. The effects of low-level laser therapy on condylar growth with a mandibular advancement appliance in rats. Photomed Laser Surg. 2015 May;33(5):252-7. doi: 10.1089/pho.2014.3870. Epub 2015 Apr 13.
PubMed 25867096Seifi M, Maghzi A, Gutknecht N, Mir M, Asna-Ashari M. The effect of 904 nm low level laser on condylar growth in rats. Lasers Med Sci. 2010 Jan;25(1):61-5. doi: 10.1007/s10103-009-0651-x. Epub 2009 Feb 24.
PubMed 19238504
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
- The Effects of Combined Treatment With Low-level Laser and Functional Appliances on the Correction of Class II Malocclusion: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03239912
- Acronym / sponsor ID
- UDDS-Ortho-05-2017
- Conditions
- Malocclusion, Angle Class II
- Keywords
- Low-level laser, functional treatment, twin-block, RCT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 16 Jul 2017 (actual)
- Primary completion
- 15 Oct 2018 (actual)
- Study completion
- 15 Feb 2019 (actual)
- First posted
- 4 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-level laser 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: a control group and an experimental group.
Functional appliance (twin-block) will be applied for all patients. Low-level laser 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.
Detailed description
Class II malocclusion is considered as the most common malocclusion between patients.
Recently low-level laser enters the world of dentistry, some studies assessed the effect of low-level laser on the growth of mandibles and condyles in animals and showed that there is a good effect of laser on the mandible growth.
This study will evaluate the effect of low-level laser on the growth of the mandible and the duration of functional treatment.
Twin-block will be applied in two groups: The control group will receive the twin-block only, and the experimental group will receive the twin-block combined with low-level laser therapy on the TMG region.
Cephalometric radiographs will be gotten 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 group | Experimental | Device: Twin-block applianceFunctional treatment will be applied using the Twin-block appliance. |
| Twin-block combined with low level laser | Experimental | Device: Twin-block appliance, Other: Low level laserFunctional treatment will be applied using the Twin-block appliance combined with low level laser. |
Who may qualify
- Ages
- 11 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Skeletal Class II malocclusion because of mandibular retrognathia
- ANB > 4
- Overjet > 5
- SNB < 78
Key exclusion criteria (4 listed)
- 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-block applianceFunctional treatment will be achieved using the Twin-block appliance | Device | Twin-block combined with low level laser, Twin-block group |
| Low level laserFunctional treatment will be combined with low-level laser therapy on the TMG region | Other | Twin-block combined with low level laser |
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 22361310Abtahi M, Poosti M, Saghravanian N, Sadeghi K, Shafaee H. The effect of low level laser on condylar growth during mandibular advancement in rabbits. Head Face Med. 2012 Feb 23;8:4. doi: 10.1186/1746-160X-8-4.
- Background: PubMed 20219584Angeletti P, Pereira MD, Gomes HC, Hino CT, Ferreira LM. Effect of low-level laser therapy (GaAlAs) on bone regeneration in midpalatal anterior suture after surgically assisted rapid maxillary expansion. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2010 Mar;109(3):e38-46. doi: 10.1016/j.tripleo.2009.10.043.
- Background: PubMed 25867096Oksayan R, Sokucu O, Ucuncu N. The effects of low-level laser therapy on condylar growth with a mandibular advancement appliance in rats. Photomed Laser Surg. 2015 May;33(5):252-7. doi: 10.1089/pho.2014.3870. Epub 2015 Apr 13.
- Background: PubMed 19238504Seifi M, Maghzi A, Gutknecht N, Mir M, Asna-Ashari M. The effect of 904 nm low level laser on condylar growth in rats. Lasers Med Sci. 2010 Jan;25(1):61-5. doi: 10.1007/s10103-009-0651-x. Epub 2009 Feb 24.
- 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.
Ahmad S Burhan, PhD. study chair
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 appliance and Low level laser 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 4 inclusion and 4 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 NCT03239912, which also lists 4 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.