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Postoperative Pain After Root Canal Disinfection Via Diode Laser

Primary Purpose

Root Canal Infection, Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Diode laser disinfection
Pseudo diode laser disinfection
Sponsored by
Yuzuncu Yıl University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Root Canal Infection focused on measuring postoperative pain, Diode laser, retreatment

Eligibility Criteria

18 Years - 52 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ozgur Genc Sen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Diode Laser disinfection

Pseudo Diode Laser Disinfection

Arm Description

Diode laser disinfection Laser type: 940 nm diode laser Power: 1 Watt Tip: 200 micrometer fibre tip

Inactivated Diode laser application in root canal

Outcomes

Primary Outcome Measures

Post-endodontic pain after diode laser disinfection in retreatment cases
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

Post-endodontic pain after diode laser disinfection in retreatment cases
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
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.

Full Information

First Posted
May 29, 2018
Last Updated
July 11, 2018
Sponsor
Yuzuncu Yıl University
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1. Study Identification

Unique Protocol Identification Number
NCT03584880
Brief Title
Postoperative Pain After Root Canal Disinfection Via Diode Laser
Official Title
Effect of Diode Laser Disinfection on Postoperative Pain in Retreatment Cases
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
February 8, 2018 (Actual)
Primary Completion Date
May 1, 2018 (Actual)
Study Completion Date
May 4, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yuzuncu Yıl University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Root Canal Infection, Pain
Keywords
postoperative pain, Diode laser, retreatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diode Laser disinfection
Arm Type
Experimental
Arm Description
Diode laser disinfection Laser type: 940 nm diode laser Power: 1 Watt Tip: 200 micrometer fibre tip
Arm Title
Pseudo Diode Laser Disinfection
Arm Type
Placebo Comparator
Arm Description
Inactivated Diode laser application in root canal
Intervention Type
Device
Intervention Name(s)
Diode laser disinfection
Intervention Description
Root canal disinfection using a 940 nm dental laser after the removal of root canal filling of failed endodontic cases.
Intervention Type
Device
Intervention Name(s)
Pseudo diode laser disinfection
Intervention Description
Without activating laser energy, same procedure as experimental group was performed (Sham laser application)
Primary Outcome Measure Information:
Title
Post-endodontic pain after diode laser disinfection in retreatment cases
Description
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.
Time Frame
24 hours postoperatively
Secondary Outcome Measure Information:
Title
Post-endodontic pain after diode laser disinfection in retreatment cases
Description
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.
Time Frame
24 to 48 hours postoperatively
Title
Post-endodontic pain after diode laser disinfection in retreatment cases
Description
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.
Time Frame
48 to 72 hours postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
52 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ozgur Genc Sen
Organizational Affiliation
Yuzuncu Yil University, Faculty of Dentistry
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Melih Kaya, PhD
Organizational Affiliation
Yuzuncu Yıl University, Faculty of Dentistry
Official's Role
Study Director
Facility Information:
Facility Name
Ozgur Genc Sen
City
Van
State/Province
Türkiye (tur)
ZIP/Postal Code
65080
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31050927
Citation
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.
Results Reference
derived

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Postoperative Pain After Root Canal Disinfection Via Diode Laser

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