Effect of the Diode Laser (940nm) on Orthodontics

NCT05469451 | Unknown

• 1 other identifier: UniCIEOLaser01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the effect of the low power density 940nm diode laser in the total relief of dental crowding during the alignment phase and the perception of pain in patients who initiate orthodontic treatment.

Conditions

Low Level Laser Therapy; Pain; Crowding, Tooth

Keywords

Low-Level Light Therapy; Malocclusion; Orthodontics; Pain

Outcome Measures

Primary Outcomes (1)

• Total relief of dental crowding

  This was measured as the resolution of anterior crowding in the lower arch calculated by the difference of Little's irregularity index, the distance in millimeters between the contact points from mesial of the canine to mesial of the contralateral canine in the lower arch in the digitized models in each of the established times. Perfect alignment from the mesial aspect of the left canine to the mesial aspect of the right canine would theoretically have a score of 0, with greater crowding represented by greater displacement and thus a higher index score.

  3 months

Secondary Outcomes (1)

• Pain perception

  3 months

Study Arms (2)

Group 1: irradiated with low power laser (940nm)

EXPERIMENTAL

Irradiated with a low power density laser of 940 (nm), 100 megawatt, which will be calibrated and the result of the calibration will be checked with the use of the power meter. The equipment used will be a diode laser (BIOLASE™), the area to be irradiated will be the anterior segment of the lower arch, each tooth will be irradiated for a time of 10 seconds on the vestibular surfaces of the teeth and 10 seconds on the lingual surfaces of the teeth, both at gingival level and at apical level in scanning mode.

Procedure: Low level laser therapy

Group 2: Simulated that they were irradiated.

PLACEBO COMPARATOR

Group 2: it was simulated that they were irradiated.

Procedure: Low level laser therapy

Interventions

Low level laser therapy PROCEDURE

Irradiated with a low power density laser of 940 (nm), 100 megawatt, which will be calibrated and the result of the calibration will be checked with the use of the power meter. The equipment used will be a diode laser (BIOLASE™), the area to be irradiated will be the anterior segment of the lower arch, each tooth will be irradiated for a time of 10 seconds on the vestibular surfaces of the teeth and 10 seconds on the lingual surfaces of the teeth, both at gingival level and at apical level in scanning mode.

Group 1: irradiated with low power laser (940nm); Group 2: Simulated that they were irradiated.

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Ages between 20 and 40 years
• Male or female
• All lower permanent teeth or at least 36 to 46
• Little's irregularity index 3mm to 6mm
• Without prior orthodontic treatment
• Periodontally stable
• Non-smokers
• Voluntarily agreed to participate in the study by signing the informed consent

You may not qualify if:

• Patients with a history of long-term medications that interfere with bone metabolism and / or pain synthesis (bisphosphonates, anti-inflammatory or analgesic drugs and hormonal supplements
• Systemic diseases (Diabetes, hyperthyroidism, disease with bone metabolism)
• Pregnant women
• Infants
• Patients who, during the alignment phase, require the implementation of metal ligatures, springs to expand spaces and lace back uses in the technique.

Sponsors & Collaborators

• Fundación Universitaria CIEO: lead

Study Sites (1)

Fundación Universitaria UniCIEO

Bogotá, 110111, Colombia

Location

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MeSH Terms

Conditions

Pain; Malocclusion

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Diana M Montoya, MSc

  Fundación Universitaria CIEO

  STUDY CHAIR

Central Study Contacts

Diana M Montoya, MSc

CONTACT

3164469500; dm.montoya@unicieo.edu.co

Alexandra Perez, MSc

CONTACT

3214516767; a.perez@unicieo.edu.co

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The patients participating in the clinical trial, the statistician, the students and the study operators who are going to measure Little's irregularity index will be blinded to the interventions, except the principal investigator.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 50 randomized subjects, 25 per group, seen during the alignment phase with ages between 20 and 40 years, male or female, with all lower permanent teeth or at least 36 to 46, with Little's irregularity index 3mm to 6mm, without prior orthodontic treatment, periodontally stable, non-smokers and who voluntarily agreed to participate in the study by signing the informed consent.

Study Record Dates

• First Submitted: July 18, 2022
• First Posted: July 21, 2022
• Study Start: August 20, 2022
• Primary Completion: December 20, 2022
• Study Completion: December 20, 2022
• Last Updated: August 4, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)