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Treatment of Class II Malocclusion Combined With Low-level Laser

Primary Purpose

Malocclusion, Angle Class II

Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
Twin-block appliance
Low level laser
Sponsored by
Damascus University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malocclusion, Angle Class II focused on measuring Low-level laser, functional treatment, twin-block, RCT

Eligibility Criteria

11 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Damascus University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Twin-block group

Twin-block combined with low level laser

Arm Description

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

Functional treatment will be applied using the Twin-block appliance combined with low level laser.

Outcomes

Primary Outcome Measures

The duration of functional treatment
The duration of the functional treatment will be measured and compared between groups.

Secondary Outcome Measures

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.

Full Information

First Posted
July 28, 2017
Last Updated
July 16, 2019
Sponsor
Damascus University
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1. Study Identification

Unique Protocol Identification Number
NCT03239912
Brief Title
Treatment of Class II Malocclusion Combined With Low-level Laser
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
July 16, 2017 (Actual)
Primary Completion Date
October 15, 2018 (Actual)
Study Completion Date
February 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Damascus University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion, Angle Class II
Keywords
Low-level laser, functional treatment, twin-block, RCT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Twin-block group
Arm Type
Experimental
Arm Description
Functional treatment will be applied using the Twin-block appliance.
Arm Title
Twin-block combined with low level laser
Arm Type
Experimental
Arm Description
Functional treatment will be applied using the Twin-block appliance combined with low level laser.
Intervention Type
Device
Intervention Name(s)
Twin-block appliance
Intervention Description
Functional treatment will be achieved using the Twin-block appliance
Intervention Type
Other
Intervention Name(s)
Low level laser
Intervention Description
Functional treatment will be combined with low-level laser therapy on the TMG region
Primary Outcome Measure Information:
Title
The duration of functional treatment
Description
The duration of the functional treatment will be measured and compared between groups.
Time Frame
After functional treatment which will take approximately 8 months
Secondary Outcome Measure Information:
Title
Dentoskeletal effects of the functional treatment
Description
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.
Time Frame
Changes will be evaluated before and after functional treatment which will take approximately 8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmad S Burhan, PhD.
Organizational Affiliation
Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria
Official's Role
Study Chair
Facility Information:
Facility Name
Damascus University
City
Damascus
ZIP/Postal Code
00963
Country
Syrian Arab Republic

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The Individual participant data will be only available for the researchers in the department of Orthodontics, Damascus University
Citations:
PubMed Identifier
22361310
Citation
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.
Results Reference
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PubMed Identifier
20219584
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.
Results Reference
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PubMed Identifier
25867096
Citation
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.
Results Reference
background
PubMed Identifier
19238504
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.
Results Reference
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Treatment of Class II Malocclusion Combined With Low-level Laser

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