Effect of the Diode Laser (940nm) on Orthodontics

Pain Clinical Trial

Official title:

Effect of Diode Laser (940nm) on Total Relief of Dental Crowding and Pain Perception in Orthodontics: Randomized Clinical Trial (RCT)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05469451
• Other study ID #: UniCIEOLaser01
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 20, 2022
• Est. completion date: December 20, 2022

Study information

• Verified date: August 2022
• Source: Fundación Universitaria CIEO
• Contact: Diana M Montoya, MSc
• Phone: 3164469500
• Email: dm.montoya[@]unicieo.edu.co
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 20, 2022
• Est. primary completion date: December 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Crowding, Tooth
• Low Level Laser Therapy
• Malocclusion
• Pain

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Colombia	Fundación Universitaria UniCIEO	Bogotá

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Universitaria CIEO

Country where clinical trial is conducted

Colombia, 

References & Publications (28)

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* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pain perception	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.	3 months