Effect of Laser Application in Pain Management Following the Use of Orthodontic Elastomeric Separators

Orthodontic Treatment Clinical Trial

Official title:

Evaluation of Low Level Laser Therapy (LLLT) Effect on Pain Management Caused by Orthodontic Elastomeric Separators

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02209818
• Other study ID #: UDDS-Perio-06-2014
• Status: Completed
• Phase: N/A
• First received: August 4, 2014
• Last updated: March 11, 2016
• Start date: August 2014
• Est. completion date: February 2016

Study information

• Verified date: March 2016
• Source: Damascus University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Syria: Higher Education and Scientific Research Committee, University of Damascus
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to evaluate the effect of low level laser therapy (LLLT) on pain management in people commencing orthodontic treatment. The study design is a randomized controlled trial.

Participants' pain will be dealt with by laser irradiation in one side of the jaw randomly, and the other side will be treated by a placebo procedure. Pain assessment will be measured using Visual Analog Scales (VAS).

The hypothesis of this study is that laser irradiation decreases the amount of pain following the insertion of orthodontic separators.

Description:

Here we have two groups:

The first group will undergo one dose of irradiation which is going to be applied on one side of the mouth whereas the opposing side will serve as a control side (placebo).

The second group will undergo two doses of irradiation which is going to be applied on one side of the mouth whereas the opposing side will serve as a control side (placebo).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: February 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 45 Years

Eligibility

Inclusion Criteria:

• Participants should have healthy periodontal structures, healthy teeth.

• Presence of first molar in both side of the jaw.

Exclusion Criteria:

• systemic diseases

• chronic pain or neurological pain

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Orthodontic Treatment

Intervention

Radiation:
• Laser Irradiation One dose

• Laser Irradiation Two doses

Locations

Country	Name	City	State
Syrian Arab Republic	Department of Periodontics, University of Damascus Dental School	Damascus

Sponsors (1)

Lead Sponsor	Collaborator
Damascus University

Country where clinical trial is conducted

Syrian Arab Republic, 

References & Publications (7)

Abtahi SM, Mousavi SA, Shafaee H, Tanbakuchi B. Effect of low-level laser therapy on dental pain induced by separator force in orthodontic treatment. Dent Res J (Isfahan). 2013 Sep;10(5):647-51. — View Citation

Artés-Ribas M, Arnabat-Dominguez J, Puigdollers A. Analgesic effect of a low-level laser therapy (830 nm) in early orthodontic treatment. Lasers Med Sci. 2013 Jan;28(1):335-41. doi: 10.1007/s10103-012-1135-y. Epub 2012 Jul 21. — View Citation

Eslamian L, Borzabadi-Farahani A, Hassanzadeh-Azhiri A, Badiee MR, Fekrazad R. The effect of 810-nm low-level laser therapy on pain caused by orthodontic elastomeric separators. Lasers Med Sci. 2014 Mar;29(2):559-64. doi: 10.1007/s10103-012-1258-1. Epub 2013 Jan 20. — View Citation

Fujiyama K, Deguchi T, Murakami T, Fujii A, Kushima K, Takano-Yamamoto T. Clinical effect of CO(2) laser in reducing pain in orthodontics. Angle Orthod. 2008 Mar;78(2):299-303. doi: 10.2319/033007-153.1. — View Citation

Huang TH, Liu SL, Chen CL, Shie MY, Kao CT. Low-level laser effects on simulated orthodontic tension side periodontal ligament cells. Photomed Laser Surg. 2013 Feb;31(2):72-7. doi: 10.1089/pho.2012.3359. Epub 2013 Jan 17. — View Citation

Kim WT, Bayome M, Park JB, Park JH, Baek SH, Kook YA. Effect of frequent laser irradiation on orthodontic pain. A single-blind randomized clinical trial. Angle Orthod. 2013 Jul;83(4):611-6. doi: 10.2319/082012-665.1. Epub 2012 Dec 14. — View Citation

Nóbrega C, da Silva EM, de Macedo CR. Low-level laser therapy for treatment of pain associated with orthodontic elastomeric separator placement: a placebo-controlled randomized double-blind clinical trial. Photomed Laser Surg. 2013 Jan;31(1):10-6. doi: 10.1089/pho.2012.3338. Epub 2012 Nov 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Pain Perception	Pain assessment will be performed using a Visual Analog Scale (VAS).	Pain will be evaluated at 1, 6, 24, 48, and 72 hours after laser irradiation	No