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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

Tracking Information
First Submitted Date  ICMJE May 29, 2018
First Posted Date  ICMJE July 12, 2018
Last Update Posted Date July 13, 2018
Actual Study Start Date  ICMJE February 8, 2018
Actual Primary Completion Date May 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 29, 2018)
Post-endodontic pain after diode laser disinfection in retreatment cases [ Time Frame: Hours 24 ]
Pain intensity was evaluated at 24 hours after retreatment procedures. According to the numeric pain scale (NRS) given to the participants.
Change History Complete list of historical versions of study NCT03584880 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2018)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2018)
  • Post-endodontic pain after diode laser disinfection in retreatment cases [ Time Frame: Hours 48 ]
    Pain intensity was evaluated at 48 hours after retreatment procedures. According to the numeric pain scale (NRS) given to the participants.
  • Post-endodontic pain after diode laser disinfection in retreatment cases [ Time Frame: Hours 72 ]
    Pain intensity was evaluated at 72 hours after retreatment procedures. According to the numeric pain scale (NRS) given to the participants.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Postoperative Pain After Root Canal Disinfection Via Diode Laser
Official Title  ICMJE Effect of Diode Laser Disinfection on Postoperative Pain in Retreatment Cases
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Root Canal Infection
  • Pain
Intervention  ICMJE
  • Device: Diode laser disinfection
    Root canal disinfection using a 940 nm dental laser after the removal of root canal filling of failed endodontic cases.
  • Device: Pseudo diode laser disinfection
    Without activating laser energy, same procedure as experimental group was performed (Sham laser application)
Study Arms  ICMJE
  • Experimental: Diode Laser disinfection
    Diode laser disinfection Laser type: 940 nm diode laser Power: 1 Watt Tip: 200 micrometer fibre tip
    Intervention: Device: Diode laser disinfection
  • Placebo Comparator: Pseudo Diode Laser Disinfection
    Inactivated Diode laser application in root canal
    Intervention: Device: Pseudo diode laser disinfection
Publications * Genc Sen O, Kaya M. Effect of Root Canal Disinfection with a Diode Laser on Postoperative Pain After Endodontic Retreatment. Photobiomodul Photomed Laser Surg. 2019 Feb;37(2):85-90. doi: 10.1089/photob.2018.4539. Epub 2019 Jan 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 29, 2018)
84
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 4, 2018
Actual Primary Completion Date May 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 52 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03584880
Other Study ID Numbers  ICMJE B.30.2.YYU.0.01.00.00/124
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ozgur Genc Sen, Yuzuncu Yıl University
Study Sponsor  ICMJE Yuzuncu Yıl University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ozgur Genc Sen Yuzuncu Yil University, Faculty of Dentistry
Study Director: Melih Kaya, PhD Yuzuncu Yıl University, Faculty of Dentistry
PRS Account Yuzuncu Yıl University
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP