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

Not Applicable

Completed

• Conditions: Orthodontic Treatment
• Interventions: Radiation: Laser Irradiation One dose; Radiation: Laser Irradiation Two doses

• Registration Number: NCT02209818
• Lead Sponsor: Damascus University

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).

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-08-04
• Study First Submitted QC: 2014-08-04
• Study First Posted: 2014-08-06
• Primary Completion: 2015-09
• Study Completion: 2016-02
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-11
• Last Update Posted: 2016-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laser Irradiation One Dose	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).
Laser Irradiation Two doses	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).

Primary Outcome Measures

Name	Time	Method
Change in Pain Perception	Pain will be evaluated at 1, 6, 24, 48, and 72 hours after laser irradiation	Pain assessment will be performed using a Visual Analog Scale (VAS).

Trial Locations

Locations (1)

Department of Periodontics, University of Damascus Dental School; 🇸🇾 Damascus, Syrian Arab Republic