The Effect of Solvent Usage on Post-treatment Pain

Not Applicable

Completed

• Conditions: Root Canal Infection; Pain
• Interventions: Procedure: Non-solvent; Procedure: Solvent

• Registration Number: NCT03756363
• Lead Sponsor: Yuzuncu Yıl University

Brief 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.

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 Timeline

• Study Start: 2018-10-22
• Study First Submitted: 2018-11-26
• Study First Submitted QC: 2018-11-26
• Study First Posted: 2018-11-28
• Primary Completion: 2019-01-05
• Study Completion: 2019-01-10
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-03
• Last Update Posted: 2019-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-solvent	Non-solvent	Non-solvent use of a rotary retreatment system
Solvent	Solvent	Solvent use in combination with a rotary retreatment system

Primary Outcome Measures

Name	Time	Method
Postoperative pain after removal of gutta-percha with or without solvent	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 Outcome Measures

Name	Time	Method
Postoperative pain after removal of gutta-percha with or without solvent	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.

Trial Locations

Locations (1)

Ozgur Genc Sen; 🇹🇷 Van, Turkey