Clinical trial NCT05469451: Effect of the Diode Laser (940nm) on Orthodontics
Official title: Effect of Diode Laser (940nm) on Total Relief of Dental Crowding and Pain Perception in Orthodontics: Randomized Clinical Trial (RCT)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Level Laser Therapy
Pain
Crowding, Tooth
Keywords: Low-Level Light Therapy
Malocclusion
Orthodontics
Pain
Lead sponsor: Fundación Universitaria CIEO
Sponsor class: OTHER
First posted: 2022-07-21
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Total relief of dental crowding
timeFrame: 3 months
Secondary outcomes:
measure: Pain perception
timeFrame: 3 months
Other outcomes:
Locations:
city: Bogotá
country: Colombia
facility: Fundación Universitaria UniCIEO
Study officials:
affiliation: Fundación Universitaria CIEO
name: Diana M Montoya, MSc
role: STUDY_CHAIR
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