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Comparative Evaluation of Different File Systems in Postoperative Pain

NCT ID: NCT03708081

Last Updated: 2018-12-20

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

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-01

Study Completion Date

2018-10-05

Brief Summary

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Postoperative pain is a frequent complication associated with root canal treatment. The apical extrusion of irrigant and debris, including bacteria and necrotic tissue, may lead to postoperative pain, periapical inflammation, and flare-ups. The instrumentation technique and the file design may affect the amount of debris extrusion.

The aim of this study was to evaluate the influence of instrumentation techniques on the incidence and intensity of postoperative pain after single-visit root canal treatment.

Detailed Description

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Sixty patients having root canal treatment indication and a single root canal were included in the study. The patients were randomly assigned into 2 groups according to root canal instrumentation technique used. In group 1; ProTaper Next (Dentsply Maillefer, Ballaigues, Switzerland) instruments with rotational motion, in group 2 TF Adaptive (SybronEndo, Orange, CA) instruments with adaptive motion were used for root canal treatments. Root canal treatment was carried out in a single visit and the severity of postoperative pain was assessed via a four-point pain intensity scale. All the participants were called through the phone at 12, 24 and 48h to obtain the pain scores. Data were analyzed using the Mann Whitney-U, Friedman and Wilcoxon tests.

Conditions

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Pulpitis Periapical Periodontitis Necrotic Pulp

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Root canal treatments will be completed by ProTaper Next instruments with rotational motion

ProTaper Next

Intervention Type PROCEDURE

Root canal instrument

Group 2

Root canal treatments will be completed TF Adaptive instruments with adaptive motion.

TF Adaptive

Intervention Type PROCEDURE

Root canal instrument

Interventions

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ProTaper Next

Root canal instrument

Intervention Type PROCEDURE

TF Adaptive

Root canal instrument

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* having root canal treatment indication
* single root canal

Exclusion Criteria

* previously treated tooth
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bulent Ecevit University

OTHER

Sponsor Role lead

Responsible Party

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Mustafa Murat Koçak

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Bülent Ecevit University, Faculty of Dentistry

Zonguldak, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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BEU

Identifier Type: -

Identifier Source: org_study_id