Postoperative Pain After Root Canal Disinfection Via Diode Laser

July 11, 2018 updated by: Ozgur Genc Sen, Yuzuncu Yıl University

Effect of Diode Laser Disinfection on Postoperative Pain in Retreatment Cases

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

84

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

  • Turkey
    • Türkiye (tur)
      • Van, Türkiye (tur), Turkey, 65080
        • Ozgur Genc Sen

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

18 years to 52 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 to 48 hours postoperatively
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.
48 to 72 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yuzuncu Yıl University

Investigators

  • Principal Investigator: Ozgur Genc Sen, Yuzuncu Yil University, Faculty of Dentistry
  • Study Director: Melih Kaya, PhD, Yuzuncu Yıl University, Faculty of Dentistry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

February 8, 2018

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

May 4, 2018

Study Registration Dates

First Submitted

May 29, 2018

First Submitted That Met QC Criteria

June 29, 2018

First Posted (Actual)

July 12, 2018

Study Record Updates

Last Update Posted (Actual)

July 13, 2018

Last Update Submitted That Met QC Criteria

July 11, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B.30.2.YYU.0.01.00.00/124

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

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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