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

Post-operative Pain Clinical Trial

— Endodontics  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06357481
• Other study ID #: SaglikBilimleriU-22-122
• Status: Completed
• Phase: N/A
• Start date: January 26, 2023
• Est. completion date: January 28, 2024

Study information

• Verified date: March 2024
• Source: Saglik Bilimleri Universitesi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 28, 2024
• Est. primary completion date: January 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 67 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Pulp Diseases
• Endodontic Disease
• Pain, Postoperative
• Periapical Periodontitis
• Periodontitis
• Post-operative Pain
• Retreatment
• Symptomatic Periapical Periodontitis

Intervention

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.

Locations

Country	Name	City	State
Turkey	Hüseyin Gürkan Güneç	Istanbul	Uskudar

Sponsors (1)

Lead Sponsor	Collaborator
Saglik Bilimleri Universitesi

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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.133 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Guidelines for reporting randomized trials in Endodontics