Laser Therapy on Controlling Pain During Orthondontic Treatment

Malocclusion Clinical Trial

Official title:

Low Level 810nm Laser Therapy on Controlling Pain During a First Stage of Orthondontic Treatment

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04628390
• Other study ID #: UniCIEO-laser001
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 20, 2020
• Est. completion date: February 20, 2021

Study information

• Verified date: November 2020
• Source: Fundación Universitaria CIEO
• Contact: Jaime E. Donado, DDS
• Phone: 3208388047
• Email: jaimedonadom[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: February 20, 2021
• Est. primary completion date: January 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Malocclusion

Intervention

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

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

Locations

Country	Name	City	State
Colombia	Fundación universitaria CIEO - UniCIEO	Bogotá

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Universitaria CIEO

Country where clinical trial is conducted

Colombia, 

References & Publications (10)

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. — View Citation

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. — View Citation

Lirani-Galvão 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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2007 Mar 3. — View Citation

Sommer AP, Schemmer P, Pavláth AE, Försterling HD, Mester ÁR, 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. — View Citation

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. Review. — View Citation

Tecco S, D'Attilio M, Tetè 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. — View Citation

Timberlake GT, Enwemeka CS. An inexpensive, automated instrument for laser irradiation of cultured cells. Photomed Laser Surg. 2004 Jun;22(3):233-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Need for analgesic	Frequency and Need after the treatment	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)