The Effect of Solvent Usage on Post-treatment Pain

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03756363
• Other study ID #: B.30.2.YYU.0.01.00.00/125
• Status: Completed
• Phase: N/A
• Start date: October 22, 2018
• Est. completion date: January 10, 2019

Study information

• Verified date: July 2019
• Source: Yuzuncu Yil University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: January 10, 2019
• Est. primary completion date: January 5, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain
• Root Canal Infection

Intervention

Procedure:
• Non-solvent
Root canal filling removal using ProTaper retreatment instruments. Single session retreatment procedures.
• Solvent
Root canal filling removal using ProTaper retreatment instruments in combination with a gutta percha solvent. Single session retreatment procedures.

Locations

Country	Name	City	State
Turkey	Ozgur Genc Sen	Van

Sponsors (1)

Lead Sponsor	Collaborator
Yuzuncu Yil University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain after removal of gutta-percha with or without solvent	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	Postoperative pain after removal of gutta-percha with or without solvent	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
Secondary	Postoperative pain after removal of gutta-percha with or without solvent	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