The Effect of Solvent Usage on Post-treatment Pain

July 3, 2019 updated by: Ozgur Genc Sen, Yuzuncu Yıl University

Postoperative Pain After Removal of Gutta-percha From Root Canals in Endodontic Retreatment Using a Solvent

No clinical evidence has been yet published regarding the comparison of postoperative pain after removal of the root canal fillings with or without solvent. The aim of this study was to evaluate the effect of combined usage of ProTaper retreatment instruments and a gutta-percha solvent, on the postoperative pain intensity after retreatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Scientific literature contains a few studies regarding the amount of apically extruded debris caused by solvent or solvent free use of rotary instruments. It was reported that the use of ProTaper retreatment instruments in combination with gutta-percha solvent reduced the amount of apically extruded debris compared to their solvent free use. Nevertheless,no clinical evidence has been yet published regarding the comparison of postoperative pain after removal of the root canal fillings with or without solvent. The aim of this study was to evaluate the effect of combined usage of ProTaper retreatment instruments and gutta-percha solvent, on the postoperative pain intensity after retreatment. The adult patients (18-59 ages) who referred to Department of Endodontics with a diagnose of failed root canal treatment were examined radiographically and clinically. Endodontically treated, clinically asymptomatic, single-rooted teeth with one canal exhibiting chronic periapical infection were included. A hundred cases who matched the determined criteria were selected and randomly allocated to two groups:

Non-solvent Group (n=50):

ProTaper retreatment instruments were used in combination with with X-Smart electric motor for the removal of root canal fillings.

Solvent Group (n=50):

ProTaper retreatment instruments were used with the abovementioned technique but in combination with a gutta-percha solvent

Study Type

Interventional

Enrollment (Actual)

90

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
      • Van, 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 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Systemically healthy patient who has a failed root canal treatment.
  • Asymptomatic single rooted teeth that had an initial root canal filling diagnosed with chronic apical periodontitis.
  • Patients agreed to parcitipate in the study

Exclusion Criteria:

  • Overfilled teeth,
  • teeth with intraradicular posts,
  • existence of a sinus tract,
  • consumption of antibiotics or analgesics within one month,
  • 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: Non-solvent
Non-solvent use of a rotary retreatment system
Procedure: Non-solvent
Root canal filling removal using ProTaper retreatment instruments. Single session retreatment procedures.
Experimental: Solvent
Solvent use in combination with a rotary retreatment system
Procedure: Solvent
Root canal filling removal using ProTaper retreatment instruments in combination with a gutta percha solvent. Single session retreatment procedures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain after removal of gutta-percha with or without solvent
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
Postoperative pain after removal of gutta-percha with or without solvent
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
Postoperative pain after removal of gutta-percha with or without solvent
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 G Genc Sen, Yuzuncu Yil University, Faculty of Dentistry
  • Study Director: Ali G Erdemir, Yuzuncu Yil 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)

October 22, 2018

Primary Completion (Actual)

January 5, 2019

Study Completion (Actual)

January 10, 2019

Study Registration Dates

First Submitted

November 26, 2018

First Submitted That Met QC Criteria

November 26, 2018

First Posted (Actual)

November 28, 2018

Study Record Updates

Last Update Posted (Actual)

July 8, 2019

Last Update Submitted That Met QC Criteria

July 3, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • B.30.2.YYU.0.01.00.00/125

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

No

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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