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Management of Post Endodontic Re-treatment Pain With Low-Level Laser Therapy

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ClinicalTrials.gov Identifier: NCT03023761
Recruitment Status : Unknown
Verified January 2017 by saranaz azari-marhabi, Shahid Beheshti University.
Recruitment status was:  Recruiting
First Posted : January 18, 2017
Last Update Posted : January 18, 2017
Sponsor:
Information provided by (Responsible Party):
saranaz azari-marhabi, Shahid Beheshti University

Study Description
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Brief Summary:
In this clinical trial investigators aimed to evaluate Post endodontic re-treatment pain after irradiation of low level laser therapy

Condition or disease Intervention/treatment Phase
Pain Device: low level laser Device: laser sham Not Applicable

Detailed Description:
In this clinical trial, 61 patients requiring endodontic retreatments in the posterior teeth were selected. A single visit Endodontic retreatment was done. After biomechanical preparation, Low Level Laser was irradiated to the buccal and lingual mucosa overlying the apices of the target tooth in the experimental group. In the control group patients received placebo laser to eliminate the probable psychological effects of laser. Laser irradiation was done with a single dose of 808 nm wavelength (Whitening Lase II- Laser DMC, Samsung, Korea) with 100 mw power, and dose of 70 J/cm2 for 80 seconds. Pain severity was recorded before the treatment, immediately after the treatment and 4, 8, 12, 24 and 48 hours after the treatment by visual analogue scale (VAS). The pain scores were statistically analyzed by chi-square test between two groups. The effects of different variables on the post-operative pain experience were also studied by means of Logistic regression.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 61 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Official Title: Management of Post Endodontic Re-treatment Pain With Low-Level Laser Therapy
Study Start Date : January 2017
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : July 2017
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: low level laser
A single visit Endodontic retreatment was done. After biomechanical preparation, Low Level Laser was irradiated to the buccal and lingual mucosa overlying the apices of the target tooth in the experimental group
 Device: low level laser
low level laser irradiation
Placebo Comparator: laser sham
In the control group patients received placebo laser to eliminate the probable psychological effects of laser.
 Device: laser sham
laser without irradiation


Outcome Measures
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Primary Outcome Measures :
  1. reduction of pain after low level laser irradiation [ Time Frame: baseline and 4, 8, 12, 24 and 48 hours after the treatment ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

- patients requiring endodontic retreatments in the posterior teeth

Exclusion Criteria:

  • systemic diseases psychologic disorders
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03023761


Contacts
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Contact: saranaz azari-marhabi 09190129151 saranazazari@yahoo.com

Locations
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Iran, Islamic Republic of
Shahid Beheshti University Recruiting
Tehran, Iran, Islamic Republic of
Contact: Saranaz azari marhabi    09190129151      
Sponsors and Collaborators
Shahid Beheshti University
Investigators
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Study Chair: mohammad asnaashari Shahid Beheshti University of Medical Sciences
More Information
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Responsible Party: saranaz azari-marhabi, assistant professor, Shahid Beheshti University
ClinicalTrials.gov Identifier: NCT03023761    
Other Study ID Numbers: 123
First Posted: January 18, 2017    Key Record Dates
Last Update Posted: January 18, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by saranaz azari-marhabi, Shahid Beheshti University:
Endodontic retreatments
Low level laser
Pain