Laser Therapy on Controlling Pain During Orthondontic Treatment
Primary Purpose
Malocclusion
Status
Unknown status
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
Laser
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Malocclusion focused on measuring Laser, orthodontic, TIP EDGE
Eligibility Criteria
Inclusion Criteria:
- Subjects must have signed and dated an informed consent form approved by the IRB in accordance with regulatory and institutional guidelines. This form must be obtained before performing any procedure related to the protocol that is not part of the subject's normal regimen.
- No need extractions
- No need Stripping
Exclusion Criteria:
- Periodontal disease
- Pregnant or lactance
- Medicated patients (analgesic, anti-inflammatory drugs, systemic corticosteroids, and calcium channel blockers)
- Cardiac markpaser
Sites / Locations
- Fundación universitaria CIEO - UniCIEO
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental
Placebo
Arm Description
The low-power therapeutic diode laser will be applied with a wavelength 810nm ± 15nm, output power 0-2 W CW / 0-4.8 W peak power (pulse mode), for a time of 20 seconds per centimeter at lo along the buccal surface of the root of the upper and lower teeth.
A simulation of the application of therapeutic laser will be carried out as a placebo effect, for a time of 20 seconds per centimeter along the vestibular surface of the root of the upper and lower teeth.
Outcomes
Primary Outcome Measures
Measure the "Change in Orthodontic Pain Levels"
The evaluation of the difference in pain levels will be determined as a percentage of change and difference in means of pain levels. The difference and the percentage will be calculated by comparing the baseline pain levels observed between the different follow-up times. A rule of three is applied to determine the percentage of change (%) and a subtraction of the pain averages to calculate the difference. Pain analysis will be performed using the visual analog scale (VAS)
Secondary Outcome Measures
Need for analgesic
Frequency and Need after the treatment
Full Information
NCT ID
NCT04628390
First Posted
November 7, 2020
Last Updated
November 20, 2020
Sponsor
Fundación Universitaria CIEO
1. Study Identification
Unique Protocol Identification Number
NCT04628390
Brief Title
Laser Therapy on Controlling Pain During Orthondontic Treatment
Official Title
Low Level 810nm Laser Therapy on Controlling Pain During a First Stage of Orthondontic Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 20, 2020 (Anticipated)
Primary Completion Date
January 20, 2021 (Anticipated)
Study Completion Date
February 20, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To evaluate the effectiveness of pain reduction on a initial orthodontic treatment by using 810nm Diode laser compared to a placebo. Methods: This study will include two parallels groups, 30 adult patients each (mean age 18 - 40) that will be asked to fill a questionnaire related with pain before starting orthodontic treatment with Tip edge technique. Patients from one of the groups will receive laser therapy on both upper and lower maxillary according to the protocol. The patients from the other group will receive a placebo simulating a laser therapy on both maxillary. After the process, both groups will be checked on different times (12hrs-24hrs-48hrs-72hrs after) by filling a questionnaire related with pain each time.
Detailed Description
This is a parallel, double-blind, controlled, single-center clinical trial conducted in systemically healthy subjects requiring orthodontic treatment without extractions at the start of treatment in Bogotá, Colombia.
Sixty patients (60) will be randomized in a 1: 1 ratio, to either of the two arms of this trial.
This study will consist of a single visit by the patient, in this visit the assembly and activation of the upper and lower orthodontic appliances will be carried out.
Measurements of the primary outcome variable will be done remotely through a virtual pain monitoring questionnaire through a visual analog scale (Baseline, 12 hours, 24 hours, 48 hours, 72 hours).
After Screening a computer-generated scrambling code will be used for allocation in blocks of 6 to the two treatments.
The identity of included patients will not be provided to the trial team, in order to preserve the blinded aspect of the trial. The identity of the research treatment associated with each randomization number will be hidden from the trial team and patients. The final analysis is scheduled for when 100% of the patients (60 subjects) reach the 72-hour evaluation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion
Keywords
Laser, orthodontic, TIP EDGE
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Sixty patients (60) will be randomized in a 1: 1 ratio, to either of the two arms of this trial.
Measurements of the primary outcome variable will be done remotely through a virtual pain monitoring questionnaire through a visual analog scale (Baseline, 12 hours, 24 hours, 48 hours, 72 hours)
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The patients participating in the clinical trial, the statistician in charge of the data analysis and the orthodontist will be blinded to the interventions carried out.
The investigator in charge of applying the intervention will not be blinded.
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
The low-power therapeutic diode laser will be applied with a wavelength 810nm ± 15nm, output power 0-2 W CW / 0-4.8 W peak power (pulse mode), for a time of 20 seconds per centimeter at lo along the buccal surface of the root of the upper and lower teeth.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
A simulation of the application of therapeutic laser will be carried out as a placebo effect, for a time of 20 seconds per centimeter along the vestibular surface of the root of the upper and lower teeth.
Intervention Type
Device
Intervention Name(s)
Laser
Other Intervention Name(s)
LLLT
Intervention Description
The laser application will be carried out only once, immediately after the cementation of the orthodontic appliance.
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Simulation laser
Intervention Description
Simulation laser application will be carried out only once, immediately after the cementation of the orthodontic appliance.
Primary Outcome Measure Information:
Title
Measure the "Change in Orthodontic Pain Levels"
Description
The evaluation of the difference in pain levels will be determined as a percentage of change and difference in means of pain levels. The difference and the percentage will be calculated by comparing the baseline pain levels observed between the different follow-up times. A rule of three is applied to determine the percentage of change (%) and a subtraction of the pain averages to calculate the difference. Pain analysis will be performed using the visual analog scale (VAS)
Time Frame
Baseline (before treatment), 12 hours (after the start of treatment), 24 hours (after the start of treatment) 48 hours (after the start of treatment) 72 hours(after the start of treatment)
Secondary Outcome Measure Information:
Title
Need for analgesic
Description
Frequency and Need after the treatment
Time Frame
Baseline (before treatment), 12 hours (after the start of treatment), 24 hours (after the start of treatment) 48 hours (after the start of treatment) 72 hours(after the start of treatment)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects must have signed and dated an informed consent form approved by the IRB in accordance with regulatory and institutional guidelines. This form must be obtained before performing any procedure related to the protocol that is not part of the subject's normal regimen.
No need extractions
No need Stripping
Exclusion Criteria:
Periodontal disease
Pregnant or lactance
Medicated patients (analgesic, anti-inflammatory drugs, systemic corticosteroids, and calcium channel blockers)
Cardiac markpaser
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jaime E. Donado, DDS
Phone
3208388047
Email
jaimedonadom@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Julio C. Castro, DDS
Phone
3134047035
Email
jc.castro@unicieo.edu.co
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaime E. Donado, DDS
Organizational Affiliation
Fundación universitaria CIEO-UniCIEO
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fundación universitaria CIEO - UniCIEO
City
Bogotá
ZIP/Postal Code
11001
Country
Colombia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaime E. Donado, DDS
Phone
3208388047
Email
jaimedonadom@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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Laser Therapy on Controlling Pain During Orthondontic Treatment
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