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Clinical Trials/NCT05811728
NCT05811728CompletedNot Applicable

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

Nourhan M.Aly1 site in 1 country20 target enrollmentStarted: February 25, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
20
Locations
1
Primary Endpoint
Measurement of alveolar bone volume

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Other
Masking
Single (Participant)

Eligibility Criteria

Ages
15 Years to 25 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Low level laser therapy

Experimental

Intervention: Low level laser therapy (Radiation)

Control

Placebo Comparator

Intervention: without beam emission (Other)

Outcomes

Primary Outcomes

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

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

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.

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).

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Nourhan M.Aly
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Nourhan M.Aly

Assistant Lecturer of Dental Public Health

University of Alexandria

Study Sites (1)

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