Postoperative Pain Associated With Three Endodontic Rotary Systems

Not Applicable

• Conditions: Acute Pulpitis
• Interventions: Device: F6 SKYTaper; Device: ONE ENDO; Device: ProTaper Universal

• Registration Number: NCT03065777
• Lead Sponsor: Cairo University

Brief Summary

Assessment of postoperative pain after root canal treatment using different rotary systems.

Detailed Description

Randomized controlled clinical trial comparing three types of endodontic rotary files to assess their effect on postoperative pain after single visit root canal treatment of premolar teeth diagnosed with acute irreversible pulpitis.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-10
• Status Verified: 2017-02
• Study First Submitted: 2017-02-15
• Study First Submitted QC: 2017-02-22
• Last Update Submitted: 2017-02-22
• Study First Posted: 2017-02-28
• Last Update Posted: 2017-02-28
• Primary Completion: 2017-08
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

• Systematically healthy patients,
• maxillary or mandibular premolar teeth with acute irreversible pulpitis and indicated for conventional endodontic treatment.

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Exclusion Criteria

• Non-vital teeth,
• teeth with apical periodontitis,
• teeth requiring endodontic retreatment,
• root resorption,
• immature / open apex,
• root canals with radiographic evidence of calcification,
• presence of more than one symptomatic tooth in the same quadrant,
• pregnancy,
• medically compromised patients,
• patients receiving medication for chronic pain,
• patients who have taken analgesics in the last 12 hours before treatment.
• teeth that have initial apical size more than 20,
• teeth that could not be treated in a single session,
• if any evidence of extrusion of root filling material noticed radiographically, patient will be excluded.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
F6 SKYTaper	F6 SKYTaper	Single file rotary system
ONE ENDO	ONE ENDO	Single file rotary system
ProTaper Universal	ProTaper Universal	Muti-file rotary system

Primary Outcome Measures

Name	Time	Method
postoperative pain	up to 72 hours after endodontic treatment	Verbal Rating Scale (VRS) with the following scores: 0. No pain.; 1. Mild pain: any discomfort of any duration that does not require analgesics.; 2. Moderate pain: pain that requires and is relieved with analgesics.; 3. Severe pain: any pain that is not relieved with analgesics.

Secondary Outcome Measures

Name	Time	Method
Number of analgesics consumed	up to 72 hours after endodontic treatment

Trial Locations

Locations (1)

Faculty of Oral and Dental Medicine - Cairo University; 🇪🇬 Cairo, Egypt