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

NCT02209818 | Completed DMC

• 1 other identifier: UDDS-Perio-06-2014
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Orthodontic Treatment

Keywords

Low level laser therapy; Elastomeric separator; Placebo; Visual analog scale; Laser irradiation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Laser Irradiation One Dose

EXPERIMENTAL

Laser irradiation will be applied in one dose for patients in this group, but only on one side of the jaw. The other side of the jaw will receive a placebo procedure (i.e. a red light beam will be emitted on the gingival tissues as if they are irradiated by a laser beam).

Radiation: Laser Irradiation One dose

Laser Irradiation Two doses

EXPERIMENTAL

Laser irradiation will be applied in two doses for patients in this group, but only on one side of the jaw. The second dose will be given after 24 hour of the first one. The other side of the jaw will receive a placebo procedure (i.e. a red light beam will be emitted on the gingival tissues as if they are irradiated by a laser beam).

Radiation: Laser Irradiation Two doses

Interventions

Laser Irradiation One dose RADIATION

Laser Irradiation One Dose

Laser Irradiation Two doses RADIATION

Laser Irradiation Two doses

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Participants should have healthy periodontal structures, healthy teeth.
• Presence of first molar in both side of the jaw.

You may not qualify if:

• systemic diseases
• chronic pain or neurological pain

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Department of Periodontics, University of Damascus Dental School

Damascus, Rif-dimashq Governorate, DM20AM18, Syria

Location

Related 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.

  PMID: 24348624 BACKGROUND

• 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.

  PMID: 23334785 BACKGROUND

• 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.

  PMID: 23153291 BACKGROUND

• 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.

  PMID: 22814893 BACKGROUND

• 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.

  PMID: 23327633 BACKGROUND

• 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.

  PMID: 23241006 BACKGROUND

• 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.

  PMID: 18251609 BACKGROUND

Study Officials

• Mai Almallah, DDS

  MSc student, Department of Periodontics, University of Damascus Dental School, Damascus

  PRINCIPAL INVESTIGATOR

• Mohammad Y Hajeer, DDS MSc PhD

  Associate Professor, Orthodontics Department, University of Damascus Dental School, Damascus

  STUDY DIRECTOR

• Wael Mahdi, DDS MSc PhD

  Senior Lecturer in Periodontics, Periodontics Department, University of Damascus Dental School

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2014
• First Posted: August 6, 2014
• Study Start: August 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: February 1, 2016
• Last Updated: March 15, 2016

Record last verified: 2016-03

Locations

SY (1)