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Effect of the Diode Laser (940nm) on Orthodontics

Primary Purpose

Low Level Laser Therapy, Pain, Crowding, Tooth

Status
Not yet recruiting
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
Low level laser therapy
Sponsored by
Fundación Universitaria CIEO
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Level Laser Therapy focused on measuring Low-Level Light Therapy, Malocclusion, Orthodontics, Pain

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Fundación Universitaria UniCIEO

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

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

Group 2: Simulated that they were irradiated.

Arm Description

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 2: it was simulated that they were irradiated.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 18, 2022
Last Updated
August 1, 2022
Sponsor
Fundación Universitaria CIEO
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1. Study Identification

Unique Protocol Identification Number
NCT05469451
Brief Title
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

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 20, 2022 (Anticipated)
Primary Completion Date
December 20, 2022 (Anticipated)
Study Completion Date
December 20, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación Universitaria CIEO

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Level Laser Therapy, Pain, Crowding, Tooth
Keywords
Low-Level Light Therapy, Malocclusion, Orthodontics, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1: irradiated with low power laser (940nm)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 2: Simulated that they were irradiated.
Arm Type
Placebo Comparator
Arm Description
Group 2: it was simulated that they were irradiated.
Intervention Type
Procedure
Intervention Name(s)
Low level laser therapy
Intervention Description
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 Measure Information:
Title
Total relief of dental crowding
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Pain perception
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Diana M Montoya, MSc
Phone
3164469500
Email
dm.montoya@unicieo.edu.co
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandra Perez, MSc
Phone
3214516767
Email
a.perez@unicieo.edu.co
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diana M Montoya, MSc
Organizational Affiliation
Fundación Universitaria CIEO
Official's Role
Study Chair
Facility Information:
Facility Name
Fundación Universitaria UniCIEO
City
Bogotá
ZIP/Postal Code
110111
Country
Colombia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandra Perez
Phone
+573214516767
Email
a.perez@unicieo.edu.co

12. IPD Sharing Statement

Plan to Share IPD
No
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Effect of the Diode Laser (940nm) on Orthodontics

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