Evaluation of Postoperative Pain After Single Visit Retreatment of Symptomatic and Asymptomatic Teeth (Endodontics)

Evaluation of Postoperative Pain After Single Visit Retreatment of Symptomatic and Asymptomatic Teeth With Minimal Invasive Rotary and Reciprocal Nickel Titanium Files: A Randomized Clinical Trial

Introduction: The aim of this study comparing the post operative pain after the retreatment of asymptomatic and symptomatic teeth that during single visit treatment with rotary and reciprocal nickel titanium files.

Methods: One hundred and forty one patients scheduled for non-surgical endodontic retreatment were included for evaluation. Eighty five patients who needed endodontic retreatment were assingned to 2 groups according to semptomatic or asemptomatic teeth and 4 subgroups with rotary and resiprocal files. Endodontic filling material was removed with One Flare and MicroMega REMOVER files in the retreatment kit. Patients then recorded their postoperative pain on a VAS scale at 24h, 48h, 72h, 7 days and 14 days post-treatment. Results were analyzed using the Shapiro-Wilk, Mann-Whitney U, Kruskal-Wallis, Dunn-Bonferroni and Pearson Chi-square tests.

Study Overview

• Status: Completed
• Conditions: Endodontic Disease; Post-operative Pain; Symptomatic Periapical Periodontitis; Retreatment; Asymptomatic Periapical Periodontitis
• Intervention / Treatment: Procedure: Endodontic Retreatment

Detailed Description

Retreatment is the procedure performed to regain healthy periapical tissues that the teeth have undergone root canal treatment are re-infected due to apical or coronal leakage, or after an inadequate root canal treatment. When primary root canal treatment fails, the first treatment option is non-surgical retreatment to eliminate the infection. In general, the reported success rate of retreatment ranges from 62% to 91%.

This randomized clinical study's primary goal is to evaluate the postoperative pain following a single visit of root canal retreatment for asymptomatic and symptomatic mandibular premolars using reciprocal and rotary file systems. Therefore, this study aims to compare the effect of one curve mini (rotary file system) and one reci (resiprocal file system) nickel-titanium file systems on postoperative pain after non surgical endodontic retreatment within symptomatic and asymptomatic teeth.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Uskudar
    • Istanbul, Uskudar, Turkey, 34450
      • Hüseyin Gürkan Güneç

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Symptomatic Apical Periodontitis
• Asymptomatic Apical Periodontitis
• Adult patients between 18-67 years aged

Exclusion Criteria:

• Patient under 18 years old
• Complicating systemic disease
• Allergies to local anesthetic agents
• Acute apical abscesses
• Periodontal pockets deeper than 5 mm or more mobilty than level 1
• Bruxist and teeth-grinding patient
• Pregnant women
• Presence of external root resorption
• Root fracture
• Root perforation
• Calcified root canals

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MICRO MEGA ONE RECI FILES in Group 1; During the non-surgical retreatments, the rotary file systems used in our treatment consist of One Reci system 25.04, 25.06, 35.04, and 45.04 files in symptomatic teeth.	Procedure: Endodontic Retreatment; A single operator procedured in one visit of non-surgical endodontic retreatment. Teeth were anesthetized using articaine hydrochloride with epinephrine 1:200,000 for mandibulary premolar teeth with one root canal. Each tooth was isolated with a rubber dam and then coronal restorations and caries were removed using sterile high-speed burs under water cooling. After preperation of the cavity access and localization of the canal orifice, all microorganisms that may have entered the root canal system are eliminated by removing the old canal filling with the One Flare and MicroMega REMOVER files in the MicroMega retreatment kit.
Experimental: MICRO MEGA ONE CURVE MINI FILES in Group 2; During the non-surgical retreatments, the rotary file systems used in our treatment consist of One Curve mini system 25.04, 25.06, 35.04, and 45.04 files in symptomatic teeth.	Procedure: Endodontic Retreatment; A single operator procedured in one visit of non-surgical endodontic retreatment. Teeth were anesthetized using articaine hydrochloride with epinephrine 1:200,000 for mandibulary premolar teeth with one root canal. Each tooth was isolated with a rubber dam and then coronal restorations and caries were removed using sterile high-speed burs under water cooling. After preperation of the cavity access and localization of the canal orifice, all microorganisms that may have entered the root canal system are eliminated by removing the old canal filling with the One Flare and MicroMega REMOVER files in the MicroMega retreatment kit.
Experimental: MICRO MEGA ONE RECI FILES in Group 3; During the non-surgical retreatments, the rotary file systems used in our treatment consist of One Reci system 25.04, 25.06, 35.04, and 45.04 files in asymptomatic teeth.	Procedure: Endodontic Retreatment; A single operator procedured in one visit of non-surgical endodontic retreatment. Teeth were anesthetized using articaine hydrochloride with epinephrine 1:200,000 for mandibulary premolar teeth with one root canal. Each tooth was isolated with a rubber dam and then coronal restorations and caries were removed using sterile high-speed burs under water cooling. After preperation of the cavity access and localization of the canal orifice, all microorganisms that may have entered the root canal system are eliminated by removing the old canal filling with the One Flare and MicroMega REMOVER files in the MicroMega retreatment kit.
Experimental: MICRO MEGA ONE CURVE MINI FILES in Group 4; During the non-surgical retreatments, the rotary file systems used in our treatment consist of One Curve mini system 25.04, 25.06, 35.04, and 45.04 files in asymptomatic teeth.	Procedure: Endodontic Retreatment; A single operator procedured in one visit of non-surgical endodontic retreatment. Teeth were anesthetized using articaine hydrochloride with epinephrine 1:200,000 for mandibulary premolar teeth with one root canal. Each tooth was isolated with a rubber dam and then coronal restorations and caries were removed using sterile high-speed burs under water cooling. After preperation of the cavity access and localization of the canal orifice, all microorganisms that may have entered the root canal system are eliminated by removing the old canal filling with the One Flare and MicroMega REMOVER files in the MicroMega retreatment kit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative pain	After repeated root canal treatments, postoperative pain is frequent. The response to pain varies depending on the situation and perception of pain is not always continuous. The pain was evaluated with a visual analog scale (VAS) (0: no pain, 1-2: discomfort, 3-4: mild, 5: moderate, 6-7: severe, 8-9: very severe, 10: worst pain possible).	Day 1, Day 2, Day 3, Day 7 and Day 14

Collaborators and Investigators

• Sponsor: Saglik Bilimleri Universitesi
• Investigators: Study Director: Huseyin Gurkan Gunec, Asst Prof, Saglik Bilimleri University

Publications and helpful links

General Publications

• Nagendrababu V, Duncan HF, Bjorndal L, Kvist T, Priya E, Jayaraman J, Pulikkotil SJ, Dummer PMH. PRIRATE 2020 guidelines for reporting randomized trials in Endodontics: explanation and elaboration. Int Endod J. 2020 Jun;53(6):774-803. doi: 10.1111/iej.13304. Epub 2020 May 9.

Helpful Links

• Guidelines for reporting randomized trials in Endodontics

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2023
• Primary Completion (Actual): January 30, 2023
• Study Completion (Actual): January 28, 2024

Study Registration Dates

• First Submitted: March 29, 2024
• First Submitted That Met QC Criteria: April 4, 2024
• First Posted (Actual): April 10, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Post-operative pain; Retreatment; Single visit; Minimal invasive files; Remover files
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Diseases; Jaw Diseases; Periapical Diseases; Pain, Postoperative; Periodontitis; Periapical Periodontitis; Dental Pulp Diseases
• Other Study ID Numbers: SaglikBilimleriU-22-122

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only after the results of the study are published in one of the international journals, they can be made available for the benefit of researchers, while any other data will not be shared.

Study Data/Documents

1. Study Protocol
   Information identifier: doi: 10.1111/iej.13304

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No