Clinical trial NCT06357481: Evaluation of Postoperative Pain After Single Visit Retreatment of Symptomatic and Asymptomatic Teeth
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-operative Pain
Retreatment
Symptomatic Periapical Periodontitis
Endodontic Disease
Asymptomatic Periapical Periodontitis
Keywords: Post-operative pain
Minimal invasive files
Single visit
Retreatment
Remover files
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eighty patients who needed endodontic retreatment were assingned to 2 groups according to symptomatic or asymptomatic teeth and 4 subgroups with rotary and resiprocal files.
Primary purpose: TREATMENT

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.

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
* Calcified root canals

Primary outcomes:
measure: Post-operative pain
timeFrame: Day 1, Day 2, Day 3, Day 7 and Day 14
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Hüseyin Gürkan Güneç
state: Uskudar
Study officials:
affiliation: Saglik Bilimleri University
name: Huseyin Gurkan Gunec, Asst Prof
role: STUDY_DIRECTOR
References:
citation: 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.