Laser Therapy on Controlling Pain During Orthondontic Treatment

NCT04628390 | Unknown DMC

• 1 other identifier: UniCIEO-laser001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Malocclusion

Keywords

Laser; orthodontic; TIP EDGE

Outcome Measures

Primary Outcomes (1)

• 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)

  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 Outcomes (1)

• Need for analgesic

  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)

Study Arms (2)

Experimental

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.

Device: Laser

Placebo

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

Laser DEVICE

The laser application will be carried out only once, immediately after the cementation of the orthodontic appliance.

Also known as: LLLT

Experimental

Placebo OTHER

Simulation laser application will be carried out only once, immediately after the cementation of the orthodontic appliance.

Also known as: Simulation laser

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Periodontal disease
• Pregnant or lactance
• Medicated patients (analgesic, anti-inflammatory drugs, systemic corticosteroids, and calcium channel blockers)
• Cardiac markpaser

Sponsors & Collaborators

• Fundación Universitaria CIEO: lead

Study Sites (1)

Fundación universitaria CIEO - UniCIEO

Bogotá, 11001, Colombia

Location

Related Publications (10)

• 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.

  PMID: 29627888 BACKGROUND

• 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.

  PMID: 22350425 BACKGROUND

• 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.

  PMID: 32395484 BACKGROUND

• 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.

  PMID: 22844284 BACKGROUND

• 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.

  PMID: 12355572 BACKGROUND

• 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.

  PMID: 15315731 BACKGROUND

• 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.

  PMID: 17199474 BACKGROUND

• 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.

  PMID: 19465738 BACKGROUND

• 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.

  PMID: 25335088 BACKGROUND

• 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.

  PMID: 17334676 BACKGROUND

MeSH Terms

Conditions

Malocclusion

Interventions

Lasers; Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Jaime E. Donado, DDS

  Fundación universitaria CIEO-UniCIEO

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jaime E. Donado, DDS

CONTACT

3208388047; jaimedonadom@yahoo.com

Julio C. Castro, DDS

CONTACT

3134047035; jc.castro@unicieo.edu.co

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS, Faculty of Endodontic Director

Model Details: 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)

Study Record Dates

• First Submitted: November 7, 2020
• First Posted: November 13, 2020
• Study Start: November 20, 2020
• Primary Completion: January 20, 2021
• Study Completion: February 20, 2021
• Last Updated: November 24, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)