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

NCT05811728 | Completed

• 1 other identifier: #202
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Level Laser Therapy; Canine Retraction; Orthodontic Tooth Movement

Outcome Measures

Primary Outcomes (5)

• Measurement of alveolar bone density

  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).

  3 months

• Measurement of alveolar bone microstructure

  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 months

• Measurement of buccal bone thickness

  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

  3 months

• Measurement of alveolar bone volume

  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

  3 months

• Measurement of bone Microstructure

  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.

  3 months

Study Arms (2)

Low level laser therapy

EXPERIMENTAL

Radiation: Low level laser therapy

Control

PLACEBO COMPARATOR

Other: without beam emission

Interventions

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).

Low level laser therapy

without beam emission OTHER

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

Control

Eligibility Criteria

• Age: 15 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nourhan M.Aly: lead

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, 21512, Egypt

Location

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Farah Y Eid, PhD

  Faculty of Dentistry, Alexandria University, Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Lecturer of Dental Public Health

Model Details: 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.

Study Record Dates

• First Submitted: April 1, 2023
• First Posted: April 13, 2023
• Study Start: February 25, 2023
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: November 21, 2023

Record last verified: 2023-11

Locations

EG (1)