Laser Therapy on Controlling Pain During Orthondontic Treatment
NCT ID: NCT04628390
Last Updated: 2020-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2020-11-20
2021-02-20
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
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)
TREATMENT
QUADRUPLE
The investigator in charge of applying the intervention will not be blinded.
Study Groups
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Experimental
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.
Laser
The laser application will be carried out only once, immediately after the cementation of the orthodontic appliance.
Placebo
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.
Placebo
Simulation laser application will be carried out only once, immediately after the cementation of the orthodontic appliance.
Interventions
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Laser
The laser application will be carried out only once, immediately after the cementation of the orthodontic appliance.
Placebo
Simulation laser application will be carried out only once, immediately after the cementation of the orthodontic appliance.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No need extractions
* No need Stripping
Exclusion Criteria
* Pregnant or lactance
* Medicated patients (analgesic, anti-inflammatory drugs, systemic corticosteroids, and calcium channel blockers)
* Cardiac markpaser
18 Years
40 Years
ALL
Yes
Sponsors
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Fundación Universitaria CIEO
OTHER
Responsible Party
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Jaime Enrique Donado Manotas
DDS, Faculty of Endodontic Director
Principal Investigators
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Jaime E. Donado, DDS
Role: PRINCIPAL_INVESTIGATOR
Fundación universitaria CIEO-UniCIEO
Locations
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Fundación universitaria CIEO - UniCIEO
Bogotá, , Colombia
Countries
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Central Contacts
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Facility Contacts
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Jaime E. Donado, DDS
Role: primary
References
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Ordahan B, Karahan AY, Kaydok E. The effect of high-intensity versus low-level laser therapy in the management of plantar fasciitis: a randomized clinical trial. Lasers Med Sci. 2018 Aug;33(6):1363-1369. doi: 10.1007/s10103-018-2497-6. Epub 2018 Apr 7.
Genc G, Kocadereli I, Tasar F, Kilinc K, El S, Sarkarati B. Effect of low-level laser therapy (LLLT) on orthodontic tooth movement. Lasers Med Sci. 2013 Jan;28(1):41-7. doi: 10.1007/s10103-012-1059-6. Epub 2012 Feb 18.
Sommer AP, Schemmer P, Pavlath AE, Forsterling HD, Mester AR, Trelles MA. Quantum biology in low level light therapy: death of a dogma. Ann Transl Med. 2020 Apr;8(7):440. doi: 10.21037/atm.2020.03.159.
Basso FG, Pansani TN, Turrioni AP, Bagnato VS, Hebling J, de Souza Costa CA. In vitro wound healing improvement by low-level laser therapy application in cultured gingival fibroblasts. Int J Dent. 2012;2012:719452. doi: 10.1155/2012/719452. Epub 2012 Jul 15.
Pereira AN, Eduardo Cde P, Matson E, Marques MM. Effect of low-power laser irradiation on cell growth and procollagen synthesis of cultured fibroblasts. Lasers Surg Med. 2002;31(4):263-7. doi: 10.1002/lsm.10107.
Timberlake GT, Enwemeka CS. An inexpensive, automated instrument for laser irradiation of cultured cells. Photomed Laser Surg. 2004 Jun;22(3):233-9. doi: 10.1089/1549541041438614.
Lirani-Galvao AP, Jorgetti V, da Silva OL. Comparative study of how low-level laser therapy and low-intensity pulsed ultrasound affect bone repair in rats. Photomed Laser Surg. 2006 Dec;24(6):735-40. doi: 10.1089/pho.2006.24.735.
Tecco S, D'Attilio M, Tete S, Festa F. Prevalence and type of pain during conventional and self-ligating orthodontic treatment. Eur J Orthod. 2009 Aug;31(4):380-4. doi: 10.1093/ejo/cjp003. Epub 2009 May 22.
Sousa MV, Pinzan A, Consolaro A, Henriques JF, de Freitas MR. Systematic literature review: influence of low-level laser on orthodontic movement and pain control in humans. Photomed Laser Surg. 2014 Nov;32(11):592-9. doi: 10.1089/pho.2014.3789. Epub 2014 Oct 21.
Seifi M, Shafeei HA, Daneshdoost S, Mir M. Effects of two types of low-level laser wave lengths (850 and 630 nm) on the orthodontic tooth movements in rabbits. Lasers Med Sci. 2007 Nov;22(4):261-4. doi: 10.1007/s10103-007-0447-9. Epub 2007 Mar 3.
Other Identifiers
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UniCIEO-laser001
Identifier Type: -
Identifier Source: org_study_id