- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03023761
Management of Post Endodontic Re-treatment Pain With Low-Level Laser Therapy
January 17, 2017 updated by: saranaz azari-marhabi, Shahid Beheshti University
In this clinical trial investigators aimed to evaluate Post endodontic re-treatment pain after irradiation of low level laser therapy
Study Overview
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 Type
Interventional
Enrollment (Anticipated)
61
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Tehran, Iran, Islamic Republic of
- Recruiting
- Shahid Beheshti University
-
Contact:
- Saranaz azari marhabi
- Phone Number: 09190129151
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients requiring endodontic retreatments in the posterior teeth
Exclusion Criteria:
- systemic diseases psychologic disorders
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / 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
|
low level laser irradiation
|
|
PLACEBO_COMPARATOR: laser sham
In the control group patients received placebo laser to eliminate the probable psychological effects of laser.
|
laser without irradiation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
reduction of pain after low level laser irradiation
Time Frame: baseline and 4, 8, 12, 24 and 48 hours after the treatment
|
baseline and 4, 8, 12, 24 and 48 hours after the treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: mohammad asnaashari, Shahid Beheshti University of Medical Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2017
Primary Completion (ANTICIPATED)
March 1, 2017
Study Completion (ANTICIPATED)
July 1, 2017
Study Registration Dates
First Submitted
January 11, 2017
First Submitted That Met QC Criteria
January 17, 2017
First Posted (ESTIMATE)
January 18, 2017
Study Record Updates
Last Update Posted (ESTIMATE)
January 18, 2017
Last Update Submitted That Met QC Criteria
January 17, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 123 (Giresun University Scientific Research Project)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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