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

NCT ID: NCT06357481

Last Updated: 2024-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-26

Study Completion Date

2024-01-28

Brief Summary

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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

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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.

Conditions

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Post-operative Pain Retreatment Symptomatic Periapical Periodontitis Endodontic Disease Asymptomatic Periapical Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Endodontic Retreatment

Intervention Type 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 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.

Group Type EXPERIMENTAL

Endodontic Retreatment

Intervention Type 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

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.

Group Type EXPERIMENTAL

Endodontic Retreatment

Intervention Type 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 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.

Group Type EXPERIMENTAL

Endodontic Retreatment

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

67 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Saglik Bilimleri Universitesi

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Huseyin Gurkan Gunec, Asst Prof

Role: STUDY_DIRECTOR

Saglik Bilimleri University

Locations

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Hüseyin Gürkan Güneç

Istanbul, Uskudar, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 32266988 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40958962 (View on PubMed)

Study Documents

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Document Type: Study Protocol

View Document

Related Links

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https://pubmed.ncbi.nlm.nih.gov/32266988/

Guidelines for reporting randomized trials in Endodontics

Other Identifiers

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SaglikBilimleriU-22-122

Identifier Type: -

Identifier Source: org_study_id

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