Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03239912
Other study ID # UDDS-Ortho-05-2017
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 16, 2017
Est. completion date February 15, 2019

Study information

Verified date July 2019
Source Damascus University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

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.


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Twin-block appliance
Functional treatment will be achieved using the Twin-block appliance
Other:
Low level laser
Functional treatment will be combined with low-level laser therapy on the TMG region

Locations

Country Name City State
Syrian Arab Republic Damascus University Damascus

Sponsors (1)

Lead Sponsor Collaborator
Damascus University

Country where clinical trial is conducted

Syrian Arab Republic, 

References & Publications (4)

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

Outcome

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
See also
  Status Clinical Trial Phase
Recruiting NCT06297109 - Maxillary Patient Specific Implants in Bimaxillary Orthognathic Surgery N/A
Recruiting NCT05227469 - Myofunctional Therapy Twin Block N/A
Completed NCT05356780 - Predictability of Orthodontic Tooth Movement With Invisalign Aligners
Not yet recruiting NCT05467579 - Mandibular Advancement Clear Aligner Treatment in Juvenile Idiopathic Arthritis Subjects N/A
Completed NCT01530516 - Crossbow Versus Forsus Springs in Mild to Moderate Class II Malocclusion Cases N/A
Recruiting NCT04875104 - Upper Sequential Distalization With TADs and Aligners N/A
Not yet recruiting NCT05853211 - Therapeutic Effects of Class II Elastics on Aligners in Different Vertical Skelettal Patterns
Completed NCT04175405 - Low-level Laser Therapy With a 635nm Diode Laser on Orthodontic Mini-implants Stability. N/A
Completed NCT02456220 - Dentoskeletal Changes Associated With Herbst Appliance Therapy N/A
Recruiting NCT05950581 - Treatment of Skeletal Class II Malocclusion With Modified Twin-Block Appliance With Clear Plates N/A
Completed NCT03645343 - The Effect of Functional Treatment of Patients With Backward Positioned Chins on the Jaw Joint and Movements N/A
Completed NCT04276402 - Effect of Photobiomodulation by 808nm Diode Laser on the Stability of Orthodontic Mini-implants. N/A
Recruiting NCT03773783 - Study to Compare Two Functional Appliances for Class II Malocclusions N/A
Recruiting NCT05499221 - Bone Anchored Carriere Motion Appliance N/A
Completed NCT03159962 - Mandibular Response After Maxillary Orthopedic Expansion in Class II Growing Subjects N/A
Active, not recruiting NCT02010346 - The Effect of Timing on Orthodontic Treatment N/A
Completed NCT06240923 - "Three Dimensional Assessment of Maxillary Molars Following Distalization Using Two Different Approaches" N/A
Completed NCT05298280 - Vertical Effects in Class II Patients Treated With Distalization N/A
Completed NCT04556448 - RCT Comparing Invisalign and Traditional Orthodontic Treatment N/A
Completed NCT03455634 - Predictors Associated With Seeking Orthodontic Treatment, Compliance and Treatment Success N/A