Malocclusion, Angle Class II Clinical Trial
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
Verified date | July 2019 |
Source | Damascus University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | February 15, 2019 |
Est. primary completion date | October 15, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 11 Years to 14 Years |
Eligibility |
Inclusion Criteria: - Skeletal Class II malocclusion because of mandibular retrognathia - ANB > 4 - Overjet > 5 - SNB < 78 Exclusion Criteria: - Poor oral hygiene - Previous orthodontic treatment. - Patients with syndromes, clefts, or craniofacial abnormalities. - Reason of contraindication of functional treatment |
Country | Name | City | State |
---|---|---|---|
Syrian Arab Republic | Damascus University | Damascus |
Lead Sponsor | Collaborator |
---|---|
Damascus University |
Syrian Arab Republic,
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. — View Citation
Angeletti 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. — View Citation
Oksayan R, Sökücü O, Üçüncü 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. — View Citation
Seifi 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The duration of functional treatment | The duration of the functional treatment will be measured and compared between groups. | After functional treatment which will take approximately 8 months | |
Secondary | 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. | Changes will be evaluated before and after functional treatment which will take approximately 8 months |
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