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Postoperative Pain After Root Canal Disinfection Via Diode Laser

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ClinicalTrials.gov Identifier: NCT03584880
Recruitment Status : Completed
First Posted : July 12, 2018
Last Update Posted : July 13, 2018
Sponsor:
Information provided by (Responsible Party):
Ozgur Genc Sen, Yuzuncu Yıl University

Brief Summary:
The prevention and control of post-treatment pain is of great importance for the comfort of the patient as well as for the clinician's prestige. In this study, the effect of 940 nm diode laser disinfection on the postoperative pain of retreatment cases was evaluated.

Condition or disease Intervention/treatment Phase
Root Canal Infection Pain Device: Diode laser disinfection Device: Pseudo diode laser disinfection Not Applicable

Detailed Description:
From the fact that microorganisms are the most common factors causing pain, this study aimed to evaluate effect of 940 nm diode laser disinfection performed in addition to conventional irrigation on postoperative pain of retreatment cases. Eighty-four patients with chronic apical periodontitis were treated. Root canal fillings were removed using rotary files. Root canals were irrigated using sodium hypochlorite between instrument changes. Final irrigation was performed using sodium hypochlorite and ethylenediaminetetraacetic acid (EDTA). The cases were randomly allocated into 2 groups: Group 1: Diode laser disinfection group, Group 2: control group. Root canal fillings were applied and crowns were restored. All treatments were completed in a single appointment. Patients were given a pain scale and they were requested to mark the code that reflects their pain intensity during 3 days.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Diode Laser Disinfection on Postoperative Pain in Retreatment Cases
Actual Study Start Date : February 8, 2018
Actual Primary Completion Date : May 1, 2018
Actual Study Completion Date : May 4, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Diode Laser disinfection
Diode laser disinfection Laser type: 940 nm diode laser Power: 1 Watt Tip: 200 micrometer fibre tip
Device: Diode laser disinfection
Root canal disinfection using a 940 nm dental laser after the removal of root canal filling of failed endodontic cases.

Placebo Comparator: Pseudo Diode Laser Disinfection
Inactivated Diode laser application in root canal
Device: Pseudo diode laser disinfection
Without activating laser energy, same procedure as experimental group was performed (Sham laser application)




Primary Outcome Measures :
  1. Post-endodontic pain after diode laser disinfection in retreatment cases [ Time Frame: 24 hours postoperatively ]
    Pain intensity was evaluated at 24 hours after retreatment procedures. An 11-item numerical rating scale (NRS) was used to assess the pain. This NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0 -10 integers) that best reflects the intensity of their pain. Number 0 represents 'no pain' whereas number 10 represents 'pain as bad as someone can imagine'.All patients were requested to mark a number corresponding to their average pain.


Secondary Outcome Measures :
  1. Post-endodontic pain after diode laser disinfection in retreatment cases [ Time Frame: 24 to 48 hours postoperatively ]
    Pain intensity was evaluated at 48 hours after retreatment procedures. An 11-item numerical rating scale (NRS) was used to assess the pain. This NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0 -10 integers) that best reflects the intensity of their pain. Number 0 represents 'no pain' whereas number 10 represents 'pain as bad as someone can imagine' . All patients were requested to mark a number corresponding to their average pain.

  2. Post-endodontic pain after diode laser disinfection in retreatment cases [ Time Frame: 48 to 72 hours postoperatively ]
    Pain intensity was evaluated at 72 hours after retreatment procedures. An 11-item numerical rating scale (NRS) was used to assess the pain. This NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0 -10 integers) that best reflects the intensity of their pain. Number 0 represents 'no pain' whereas number 10 represents 'pain as bad as someone can imagine'. All patients were requested to mark a number corresponding to their average pain.



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Ages Eligible for Study:   18 Years to 52 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Only asymptomatic single rooted teeth that had an initial root canal filling diagnosed with chronic periodontitis (minimum size 2x2 mm)

Exclusion Criteria:

  • teeth with root canal fillings newer than 4 years, overfilled teeth, teeth with intraradicular posts, existence of a sinus tract, consumption of antibiotics within 1 month, consumption of analgesics in last 5 days, systemic disease, pregnancy, history of trauma, traumatic occlusion

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): NCT03584880


Locations
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Turkey
Ozgur Genc Sen
Van, Türkiye (tur), Turkey, 65080
Sponsors and Collaborators
Yuzuncu Yıl University
Investigators
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Principal Investigator: Ozgur Genc Sen Yuzuncu Yil University, Faculty of Dentistry
Study Director: Melih Kaya, PhD Yuzuncu Yıl University, Faculty of Dentistry

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ozgur Genc Sen, Assistant professor, Yuzuncu Yıl University
ClinicalTrials.gov Identifier: NCT03584880     History of Changes
Other Study ID Numbers: B.30.2.YYU.0.01.00.00/124
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: July 13, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Ozgur Genc Sen, Yuzuncu Yıl University:
postoperative pain
Diode laser
retreatment

Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms