Clinical trial NCT02209818: Effect of Laser Application in Pain Management Following the Use of Orthodontic Elastomeric Separators
Official title: Evaluation of Low Level Laser Therapy (LLLT) Effect on Pain Management Caused by Orthodontic Elastomeric Separators
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthodontic Treatment
Keywords: Low level laser therapy
Elastomeric separator
Placebo
Visual analog scale
Laser irradiation
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2014-08-06
Enrollment: 72
Sex: ALL
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in Pain Perception
timeFrame: Pain will be evaluated at 1, 6, 24, 48, and 72 hours after laser irradiation
Secondary outcomes:
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Department of Periodontics, University of Damascus Dental School
Study officials:
affiliation: MSc student, Department of Periodontics, University of Damascus Dental School, Damascus
name: Mai Almallah, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Associate Professor, Orthodontics Department, University of Damascus Dental School, Damascus
name: Mohammad Y Hajeer, DDS MSc PhD
role: STUDY_DIRECTOR
affiliation: Senior Lecturer in Periodontics, Periodontics Department, University of Damascus Dental School
name: Wael Mahdi, DDS MSc PhD
role: STUDY_DIRECTOR
References:
citation: 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.
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.
citation: Nobrega 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.
citation: Artes-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.
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.
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.
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.