Three-dimensional Assessment of the Bone Changes Accompanying Laser-assisted Orthodontic Tooth Movement

NCT ID: NCT05811728

Last Updated: 2023-11-21

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-25

Study Completion Date

2023-08-31

Brief Summary

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Aim of the present study is to evaluate the effect of low-level laser therapy on bone quality and quantity with orthodontic tooth movement.

Detailed Description

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Conditions

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Low Level Laser Therapy Canine Retraction Orthodontic Tooth Movement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

The study is a randomized controlled clinical trial, involving the split-mouth design, with one side of the maxillary arch serving as the control group, and the other side serving as the experimental group.
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Low level laser therapy

Group Type EXPERIMENTAL

Low level laser therapy

Intervention Type RADIATION

The low-level laser applied will be a Diode laser\* emitting infrared radiation at a wavelength of 980 nm, in a continuous mode. On the experimental side, subjects will receive LLLT on days 0, 3, 7, 14, and every 2 weeks thereafter, till the termination of the study period (3 months).

Control

Group Type PLACEBO_COMPARATOR

without beam emission

Intervention Type OTHER

The laser tip will be held passively on the control side without beam emission, providing a placebo effect.

Interventions

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Low level laser therapy

The low-level laser applied will be a Diode laser\* emitting infrared radiation at a wavelength of 980 nm, in a continuous mode. On the experimental side, subjects will receive LLLT on days 0, 3, 7, 14, and every 2 weeks thereafter, till the termination of the study period (3 months).

Intervention Type RADIATION

without beam emission

The laser tip will be held passively on the control side without beam emission, providing a placebo effect.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Malocclusion that requires at least the extraction of maxillary first premolars, followed by canine retraction into the extraction site, such as Class I bimaxillary protrusion, and Class II division 1 cases.
* Normal shape and structure of the maxillary canines, with no history of root canal treatment

Exclusion Criteria

* Patients who underwent previous orthodontic treatment.
* Patients currently receiving drug therapy, e.g. hormonal therapy and corticosteroids, as well as patients with chronic diseases.
* Pregnancy and lactation.
Minimum Eligible Age

15 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nourhan M.Aly

OTHER

Sponsor Role lead

Responsible Party

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Nourhan M.Aly

Assistant Lecturer of Dental Public Health

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Farah Y Eid, PhD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Dentistry, Alexandria University, Egypt

Locations

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Faculty of Dentistry, Alexandria University

Alexandria, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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#202

Identifier Type: -

Identifier Source: org_study_id