Treatment of Class II Malocclusion Combined With Low-level Laser

Not Applicable

Completed

• Conditions: Malocclusion, Angle Class II
• Interventions: Device: Twin-block appliance; Other: Low level laser

• Registration Number: NCT03239912
• Lead Sponsor: Damascus University

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.

Study Timeline

• Study Start: 2017-07-16
• Study First Submitted: 2017-07-28
• Study First Submitted QC: 2017-08-03
• Study First Posted: 2017-08-04
• Primary Completion: 2018-10-15
• Study Completion: 2019-02-15
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-16
• Last Update Posted: 2019-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Twin-block combined with low level laser	Twin-block appliance	Functional treatment will be applied using the Twin-block appliance combined with low level laser.
Twin-block combined with low level laser	Low level laser	Functional treatment will be applied using the Twin-block appliance combined with low level laser.
Twin-block group	Twin-block appliance	Functional treatment will be applied using the Twin-block appliance.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Damascus University; 🇸🇾 Damascus, Syrian Arab Republic