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

NCT ID: NCT02209818

Last Updated: 2016-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2016-02-29

Brief Summary

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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

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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).

Conditions

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Orthodontic Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Laser Irradiation One Dose

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).

Group Type EXPERIMENTAL

Laser Irradiation One dose

Intervention Type RADIATION

Laser Irradiation Two doses

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).

Group Type EXPERIMENTAL

Laser Irradiation Two doses

Intervention Type RADIATION

Interventions

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Laser Irradiation One dose

Intervention Type RADIATION

Laser Irradiation Two doses

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Damascus University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mai Almallah, DDS

Role: PRINCIPAL_INVESTIGATOR

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

Mohammad Y Hajeer, DDS MSc PhD

Role: STUDY_DIRECTOR

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

Wael Mahdi, DDS MSc PhD

Role: STUDY_DIRECTOR

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

Locations

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Department of Periodontics, University of Damascus Dental School

Damascus, Rif-dimashq Governorate, Syria

Site Status

Countries

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Syria

References

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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.

Reference Type BACKGROUND
PMID: 24348624 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23334785 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23153291 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22814893 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23327633 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23241006 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18251609 (View on PubMed)

Other Identifiers

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UDDS-Perio-06-2014

Identifier Type: -

Identifier Source: org_study_id

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