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

NCT06357481 | Completed

• 1 other identifier: SaglikBilimleriU-22-122
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

MICRO MEGA ONE RECI FILES in Group 1

EXPERIMENTAL

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

MICRO MEGA ONE CURVE MINI FILES in Group 2

EXPERIMENTAL

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

MICRO MEGA ONE RECI FILES in Group 3

EXPERIMENTAL

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

MICRO MEGA ONE CURVE MINI FILES in Group 4

EXPERIMENTAL

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

Interventions

Endodontic Retreatment PROCEDURE

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.

MICRO MEGA ONE CURVE MINI FILES in Group 2; MICRO MEGA ONE CURVE MINI FILES in Group 4; MICRO MEGA ONE RECI FILES in Group 1; MICRO MEGA ONE RECI FILES in Group 3

Eligibility Criteria

• Age: 18 Years - 67 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Hüseyin Gürkan Güneç

Istanbul, Uskudar, 34450, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 32266988 RESULT

• Gunec HG, Pehlivan B, Topbas C, Kul AK, Sirin DA. Postoperative Pain Following Single-Visit Nonsurgical Retreatment Using Minimally Invasive Rotary vs. Reciprocating Nickel-Titanium File Systems: A Two-Arm Parallel Randomized Clinical Trial. Pain Res Manag. 2025 Sep 8;2025:6826535. doi: 10.1155/prm/6826535. eCollection 2025.

  PMID: 40958962 DERIVED

Related Links

• Guidelines for reporting randomized trials in Endodontics

MeSH Terms

Conditions

Pain, Postoperative; Dental Pulp Diseases

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Huseyin Gurkan Gunec, Asst Prof

  Saglik Bilimleri University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: April 10, 2024
• Study Start: January 26, 2023
• Primary Completion: January 30, 2023
• Study Completion: January 28, 2024
• Last Updated: April 17, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)