The Effects of EndoActivator on Postoperative Pain and Root Canal Treatment Success

NCT ID: NCT06339905

Last Updated: 2024-05-06

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

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2023-08-31

Brief Summary

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This study evaluates postoperative pain and radiographic healing of asymptomatic posterior teeth with chronic apical periodontitis following root-canal treatment performed using EndoActivator for irrigation activation.

Detailed Description

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Aim: To evaluate postoperative pain and radiographic healing of asymptomatic posterior teeth with chronic apical periodontitis following root-canal treatment performed using EndoActivator for irrigation activation.

Methodology: In this clinical trial, root-canal treatment was performed on 140 posterior teeth with chronic apical periodontitis. After routine canal preparation, patients were assigned to either a control group treated using conventional needle irrigation (CNI) without activation or to sonic irrigation activation with EndoActivator. All treatment was completed in a single visit. Patients provided self-assessments of the severity of postoperative pain at 1, 2,3 and 7 days using a Verbal Rating Scale (VRS) and Wong Baker Face Scale. Patients were recalled at 12 months for clinical and radiographic examinations. Periapical healing was evaluated using a periapical index (PAI), with scores of 1 or 2 considered to represent treatment success and scores of 3, 4, or 5 to represent treatment failure. Data were analyzed using one-way ANOVA and Kruskal-Wallis tests, with differences of P \< 0.05 considered statistically significant.

Conditions

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Periapical Periodontitis Root Canal Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Sonic Activation with EndoActivator

Sonic irrigation was performed using an EndoActivator sonic handpiece (Dentsply Tulsa Dental Specialties, Tulsa, OK, USA). A suitable-size activator tip was selected and loosely placed at 2 mm from working length, and the device was operated at 10,000 cycles/min using a pumping action to move the tip to produce vertical strokes of 2-3 mm.

Group Type EXPERIMENTAL

Sonic Activation with EndoActivator

Intervention Type PROCEDURE

sonic activation

Conventional needle irrigation (control)

Conventional needle irrigation was performed with short, in-and-out vertical strokes of 2-3 mm at a rate of approximately 100 strokes per minute.

Group Type ACTIVE_COMPARATOR

Control Needle Irrigation

Intervention Type PROCEDURE

control group

Interventions

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Sonic Activation with EndoActivator

sonic activation

Intervention Type PROCEDURE

Control Needle Irrigation

control group

Intervention Type PROCEDURE

Other Intervention Names

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EndoActivator (Dentsply Tulsa Dental Specialties, Tulsa, OK, USA) CNI

Eligibility Criteria

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Inclusion Criteria

* 18-60 patient's age
* Being systemically healthy
* Having posterior teeth (molar or premolar) with chronic apical periodontitis lesion (PAI≥3)

Exclusion Criteria

* Clinically symptomatic teeth
* Patients with complicated systemic disease (ASA 3 - 6)
* Teeth with open apex
* Teeth having curvature more than 20 degree
* Not having enough tooth structure to be isolated with rubber dam
* Patients with severe periodontal defects or deep periodontal pockets (probing depth\> 4 mm)
* A history of taking analgesics 12 hours ago or antibiotics 1 month ago
* Patients who cannot come to control sessions
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Istanbul Medipol University Hospital

OTHER

Sponsor Role lead

Responsible Party

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yeldaerdem

Director, Clinical Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Seyda Ersahan, PhD

Role: PRINCIPAL_INVESTIGATOR

Istanbul Medipol University Hospital

Locations

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Istanbul Medipol University, Faculty of Dentistry

Istanbul, Esenler, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Orstavik D. Time-course and risk analyses of the development and healing of chronic apical periodontitis in man. Int Endod J. 1996 May;29(3):150-5. doi: 10.1111/j.1365-2591.1996.tb01361.x.

Reference Type BACKGROUND
PMID: 9206419 (View on PubMed)

Ramamoorthi S, Nivedhitha MS, Divyanand MJ. Comparative evaluation of postoperative pain after using endodontic needle and EndoActivator during root canal irrigation: A randomised controlled trial. Aust Endod J. 2015 Aug;41(2):78-87. doi: 10.1111/aej.12076. Epub 2014 Sep 4.

Reference Type BACKGROUND
PMID: 25195661 (View on PubMed)

Swimberghe RCD, Buyse R, Meire MA, De Moor RJG. Efficacy of different irrigation technique in simulated curved root canals. Lasers Med Sci. 2021 Aug;36(6):1317-1322. doi: 10.1007/s10103-021-03263-8. Epub 2021 Feb 23.

Reference Type BACKGROUND
PMID: 33624186 (View on PubMed)

Brito PR, Souza LC, Machado de Oliveira JC, Alves FR, De-Deus G, Lopes HP, Siqueira JF Jr. Comparison of the effectiveness of three irrigation techniques in reducing intracanal Enterococcus faecalis populations: an in vitro study. J Endod. 2009 Oct;35(10):1422-7. doi: 10.1016/j.joen.2009.07.001.

Reference Type BACKGROUND
PMID: 19801244 (View on PubMed)

Other Identifiers

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10840098-772.02-5564

Identifier Type: -

Identifier Source: org_study_id

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