Effect of the Diode Laser (940nm) on Orthodontics

Not Applicable

• Conditions: Low Level Laser Therapy; Crowding, Tooth; Pain
• Interventions: Procedure: Low level laser therapy

• Registration Number: NCT05469451
• Lead Sponsor: Fundación Universitaria CIEO

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.

Detailed Description

Objectives: 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.

Design: Randomized clinical trial. Setting: orthodontic treatment from the Orthodontic postgraduate course at the CIEO University (CIEO), located in the city of Bogotá, Colombia Participants: 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. 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, with systemic diseases (Diabetes, hyperthyroidism, disease with bone metabolism) were excluded. , pregnant women, infants and patients who, during the alignment phase, require the implementation of metal ligatures, springs to expand spaces and lace back uses in the technique.

Intervention: group 1 irradiated with low power laser (940nm) and. Group 2: it was simulated that they were irradiated. The therapeutic laser was applied for a time of 10 seconds on the buccal surfaces of the teeth and 10 seconds on the lingual surfaces of the teeth, both at the gingival level and at the apical level in scanning mode, on the day of cementation of the appliance and subsequently every fifteen days for 3 months.

Main outcome measures: total relief of dental crowding measured through the little index in digital models and pain perception through the visual analog scale.

Randomization: Four patients were randomized with the randomized blocks technique.

Blinding (masking): 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.

Study Timeline

• Study First Submitted: 2022-07-18
• Study First Submitted QC: 2022-07-20
• Study First Posted: 2022-07-21
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-01
• Last Update Posted: 2022-08-04
• Study Start: 2022-08-20
• Primary Completion: 2022-12-20
• Study Completion: 2022-12-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2: Simulated that they were irradiated.	Low level laser therapy	Group 2: it was simulated that they were irradiated.
Group 1: irradiated with low power laser (940nm)	Low level laser therapy	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.

Primary Outcome Measures

Name	Time	Method
Total relief of dental crowding	3 months	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.

Secondary Outcome Measures

Name	Time	Method
Pain perception	3 months	by means of the visual analog scale that represents the intensity of the pain in a line from 0 to 10. At one end there is the phrase "no pain" and at the opposite end "the worst pain imaginable". A value of less than 4 on the VAS means mild or mild-moderate pain, a value between 4 and 6 implies the presence of moderate-severe pain, and a value greater than 6 implies the presence of very intense pain.

Trial Locations

Locations (1)

Fundación Universitaria UniCIEO; 🇨🇴 Bogotá, Colombia