Treatment of Class II Malocclusion Combined With Low-level Laser

The Effects of Combined Treatment With Low-level Laser and Functional Appliances on the Correction of Class II Malocclusion: A Randomized Controlled Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03239912

Enrollment

Registered

2017-08-04

Start date

2017-07-16

Completion date

2019-02-15

Last updated

2019-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malocclusion, Angle Class II

Keywords

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

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.

Interventions

DEVICETwin-block appliance

Functional treatment will be achieved using the Twin-block appliance

OTHERLow level laser

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

11 Years to 14 Years

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

Design outcomes

Primary

Measure	Time frame	Description
The duration of functional treatment	After functional treatment which will take approximately 8 months	The duration of the functional treatment will be measured and compared between groups.

Secondary

Measure	Time frame	Description
Dentoskeletal effects of the functional treatment	Changes will be evaluated before and after functional treatment which will take approximately 8 months	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.

Countries

Syria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026