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Effect of 980nm Diode Laser on Postoperative Pain and Root Canal Disinfection in Endodontic Retreatment Cases

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ClinicalTrials.gov Identifier: NCT03711357
Recruitment Status : Unknown
Verified October 2018 by Eman Nabil El-Ezaby, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : October 18, 2018
Last Update Posted : October 18, 2018
Sponsor:
Information provided by (Responsible Party):
Eman Nabil El-Ezaby, Cairo University

Study Description
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Brief Summary:
A randomized clinical trial that evaluates the effect of using 980nm diode laser intracanal irradiation on postoperative pain and root canal disinfection in endodontic retreatment cases with chronic periapical lesions

Condition or disease Intervention/treatment Phase
Postoperative Pain Radiation: 980 nm diode laser Other: placebo Not Applicable

Detailed Description:
The endodontic retreatment procedures will be carried out for the participants, then 980nm Diode laser will be used to disinfect root canals. The researcher will then take microbiological samples of the root canals, to determine count and type of microorganisms in root canals. The subject will be asked to determine his level of pain at 7 days after endodontic retreatment procedures in a visual analogue scale (VAS), and to determine number of analgesic tablets needed to relieve his pain in the given charts. The subject will then return to the clinic 7 days later to bring back his charts. The researcher then will take another microbiological sample of the root canals, and complete the endodontic retreatment procedures.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A trial with two parallel groups
Masking: Single (Participant)
Masking Description: All the participants will be blinded, as they will not know which interventional group they belong to
Primary Purpose: Prevention
Official Title: Evaluation of the Effect of 980nm Diode Laser Intracanal Irradiation on Postoperative Pain and Root Canal Disinfection in Endodontic Retreatment Cases With Chronic Periapical Lesions
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : June 2020

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: laser
980 nm diode laser (maximum output of 3 watts and coupled with a fiber optic tip of 200 µm diameter) will be used for four irradiations, of 5 seconds each, after chemo-mechanical preparation procedures.
 Radiation: 980 nm diode laser
980 nm high power diode laser device.
Placebo Comparator: Placebo
After chemo-mechanical preparation procedures, the diode laser fiber optic tip will be inserted inside the root canals but not activated.
 Other: placebo
the diode laser fiber optic tip will be inserted in root canals, but will not be activated.


Outcome Measures
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Primary Outcome Measures :
  1. postoperative pain, measured using Visual analogue scale (VAS) [ Time Frame: 7 days after root canal re-treatment procedures ]
    Visual analogue scale (VAS) will be used for to record severity of pain. It is a (0-10) scale. Criteria to determine the severity of postoperative pain will be as follows: (0: no pain), (1-3: mild pain), (4-6: moderate pain), (7-10: severe pain).


Secondary Outcome Measures :
  1. Root canal disinfection [ Time Frame: Four samples will be taken; first, second and third samples will be taken at first visit of endodontic retreatment procedures. while, the fourth sample will be taken in the second visit (7 days later). ]
    Number of microorganisms found in root canals will be determined using "Bacterial culture";"Initial sample", 'Pre-lasing sample, "Post-lasing". and "Recolonization sample", in the "Laser group" and "Placebo group".

  2. number of analgesic tablets [ Time Frame: At day 7 after endodontic retreatment procedures ]
    the participant will determine the number of analgesic tablets needed to relieve his pain after endodontic retreatment procedures.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Endodontic retreatment cases of single rooted teeth with chronic periapical lesions; with periapical radiolucency of less than 1 cm diameter will be selected.
  2. Teeth with straight root canals.
  3. Subjects aged between 18-50 years of age.
  4. No contributory medical history.
  5. No previous administration of analgesics and / or antibiotics within the previous 2 weeks.

Exclusion Criteria:

  1. Retreatment cases with complications such as separated instruments, perforations, ledges, resorption, transportation, calcifications, immature apices and over fillings.
  2. Teeth with curved roots.
  3. Swelling or sinus tract.
  4. Mutilated teeth that interfere with proper isolation and seal between visits.
  5. Subjects with generalized periodontitis, or if the tooth has probing depth of more than 3 mm.
  6. Subjects with uncontrolled diabetes or debilitating diseases.
  7. Pregnant or nursing females.
  8. Systemic disorders that necessitate antibiotic prophylaxis or prevent the use of Ibuprofen.
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: Eman Nabil El-Ezaby, Principal investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03711357    
Other Study ID Numbers: Eman Elezaby
First Posted: October 18, 2018    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make the participants data available to other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations