Treatment of Class II Malocclusion Combined With Low-level Laser

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-16

Study Completion Date

2019-02-15

Brief Summary

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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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Detailed Description

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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.

Conditions

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Malocclusion, Angle Class II

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Twin-block group

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

Group Type EXPERIMENTAL

Twin-block appliance

Intervention Type DEVICE

Functional treatment will be achieved using the Twin-block appliance

Twin-block combined with low level laser

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

Group Type EXPERIMENTAL

Twin-block appliance

Intervention Type DEVICE

Functional treatment will be achieved using the Twin-block appliance

Low level laser

Intervention Type OTHER

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

Interventions

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Twin-block appliance

Functional treatment will be achieved using the Twin-block appliance

Intervention Type DEVICE

Low level laser

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

11 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No