Treatment of Class II Malocclusion Combined With Low-level Laser

NCT03239912 | Completed DMC

• 1 other identifier: UDDS-Ortho-05-2017
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Malocclusion, Angle Class II

Keywords

Low-level laser; functional treatment; twin-block; RCT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Dentoskeletal effects of the functional treatment

  Changes will be evaluated before and after functional treatment which will take approximately 8 months

Study Arms (2)

Twin-block group

EXPERIMENTAL

Functional treatment will be applied using the Twin-block appliance.

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.

Device: Twin-block appliance; Other: Low level laser

Interventions

Twin-block appliance DEVICE

Functional treatment will be achieved using the Twin-block appliance

Twin-block combined with low level laser; Twin-block group

Low level laser OTHER

Functional treatment will be combined with low-level laser therapy on the TMG region

Twin-block combined with low level laser

Eligibility Criteria

• Age: 11 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Skeletal Class II malocclusion because of mandibular retrognathia
• ANB \> 4
• Overjet \> 5
• SNB \< 78

You may not qualify if:

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

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Damascus University

Damascus, 00963, Syria

Location

Related 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.

  PMID: 22361310 BACKGROUND

• 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.

  PMID: 20219584 BACKGROUND

• Oksayan 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.

  PMID: 25867096 BACKGROUND

• 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.

  PMID: 19238504 BACKGROUND

MeSH Terms

Conditions

Malocclusion, Angle Class II

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Ahmad S Burhan, PhD.

  Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2017
• First Posted: August 4, 2017
• Study Start: July 16, 2017
• Primary Completion: October 15, 2018
• Study Completion: February 15, 2019
• Last Updated: July 18, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)