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Completed

NCT Number: NCT03756363

The Effect of Solvent Usage on Post-treatment Pain

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.

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Key information

Conditions

Root Canal Infection Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ozgur Genc Sen

Van, 65080, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

non-solvent

Procedure

Root canal filling removal using ProTaper retreatment instruments. Single session retreatment procedures.

solvent

Procedure

Root canal filling removal using ProTaper retreatment instruments in combination with a gutta percha solvent. Single session retreatment procedures.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Yuzuncu Yil University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 28, 2018
Registry last updated
Jul 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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