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NCT Number: NCT03239912

Treatment of Class II Malocclusion Combined With Low-level Laser

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.

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Key information

Conditions

Malocclusion, Angle Class II Malocclusion Stomatognathic Diseases Tooth Diseases

Age range

11 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Damascus University

Damascus, 00963, Syria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Twin-block appliance

Device

Functional treatment will be achieved using the Twin-block appliance

Low level laser

Other

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

Primary outcomes

  1. The duration of functional treatment

    Time frame: After functional treatment which will take approximately 8 months

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

Secondary outcomes

  1. Dentoskeletal effects of the functional treatment

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Aug 4, 2017
Registry last updated
Jul 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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