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Clinical Trials/NCT06357481
NCT06357481
Completed
Not Applicable

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

Saglik Bilimleri Universitesi1 site in 1 country80 target enrollmentJanuary 26, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Post-operative Pain
Sponsor
Saglik Bilimleri Universitesi
Enrollment
80
Locations
1
Primary Endpoint
Post-operative pain
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
January 26, 2023
End Date
January 28, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Post-operative pain

Time Frame: Day 1, Day 2, Day 3, Day 7 and Day 14

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).

Study Sites (1)

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