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Completed

NCT Number: NCT05811728

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

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

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Key information

Conditions

Low Level Laser Therapy Canine Retraction Orthodontic Tooth Movement

Age range

15 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Alexandria University

Alexandria, 21512, Egypt

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Low level laser therapy

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).

without beam emission

Other

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

Primary outcomes

  1. Measurement of alveolar bone density

    Time frame: 3 months

    Bone density will be measured from cone beam computed tomography (CBCT) scans at 2 different locations on each side of the upper arch; between the canine and lateral incisor, and between the canine and second premolar. Bone density will be measured using Hounsfield Units (HU).

  2. Measurement of alveolar bone microstructure

    Time frame: 3 months

    From the CBCT scans, the maxillary alveolar process between the canine and lateral incisor, and between the canine and second premolar will be examined. Bone microstructures will be measured and calculated with a dedicated software.

  3. Measurement of buccal bone thickness

    Time frame: 3 months

    buccal bone thickness will be measured from the CBCT scans. Three points will be measured from the buccal bone to the root, at the coronal, mid-root, and apical level

  4. Measurement of alveolar bone volume

    Time frame: 3 months

    From CBCT scans, bone volume in areas of the maxillary alveolar process between the canine and lateral incisor, and between the canine and second premolar will be measured

  5. Measurement of bone Microstructure

    Time frame: 3 months

    Using the collected CBCT scans, the region of interest will be selected within the maxillary alveolar process, and fractal dimension analysis will be performed using a special software.

Sponsors and collaborators

Lead sponsor

Nourhan M.Aly

Other

Registry information

Official study title

Three-dimensional Assessment of the Bone Changes Accompanying Laser-assisted Orthodontic Tooth Movement: a Randomized Controlled Clinical Trial

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 13, 2023
Registry last updated
Nov 21, 2023

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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