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

Sponsor

Damascus University (Other)

Overall Status

Completed

CT.gov ID

NCT02209818

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Orthodontic Treatment	Radiation: Laser Irradiation One dose Radiation: Laser Irradiation Two doses	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2014

Actual Primary Completion Date :

Sep 1, 2015

Actual Study Completion Date :

Feb 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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).	Radiation: Laser Irradiation One dose
Experimental: 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).	Radiation: Laser Irradiation Two doses

Arm

Intervention/Treatment

Experimental: 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).

Radiation: Laser Irradiation One dose

Experimental: 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).

Radiation: Laser Irradiation Two doses

Outcome Measures

Primary Outcome Measures

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Periodontics, University of Damascus Dental School	Damascus		Syrian Arab Republic	DM20AM18

Sponsors and Collaborators

Damascus University

Investigators

Principal Investigator: Mai Almallah, DDS, MSc student, Department of Periodontics, University of Damascus Dental School, Damascus
Study Director: 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