Postoperative Pain Associated With Three Endodontic Rotary Systems

NCT ID: NCT03065777

Last Updated: 2017-02-28

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2017-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Acute Pulpitis

Keywords

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single file. ONE ENDO. F6 SkyTaper. ProTaper Universal. irreversible pulpitis. postoperative pain.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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ONE ENDO

Single file rotary system

Group Type EXPERIMENTAL

ONE ENDO

Intervention Type DEVICE

single file rotary system

F6 SKYTaper

Single file rotary system

Group Type EXPERIMENTAL

F6 SKYTaper

Intervention Type DEVICE

single file rotary system

ProTaper Universal

Muti-file rotary system

Group Type ACTIVE_COMPARATOR

ProTaper Universal

Intervention Type DEVICE

multi-file rotary system

Interventions

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ONE ENDO

single file rotary system

Intervention Type DEVICE

F6 SKYTaper

single file rotary system

Intervention Type DEVICE

ProTaper Universal

multi-file rotary system

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ola Adel Hassan Hafez

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ola A. Hafez, MD Student

Role: PRINCIPAL_INVESTIGATOR

Faculty of Oral and Dental Medicine - Cairo University

Alaa El-Din H. Diab, Professor

Role: STUDY_CHAIR

Faculty of Oral and Dental Medicine - Cairo University

Kareem G. Abd El-Kader, Assistant Professor

Role: STUDY_DIRECTOR

Faculty of Oral and Dental Medicine - Cairo University

Locations

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Faculty of Oral and Dental Medicine - Cairo University

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ola A. Hafez, MD Student

Role: CONTACT

Phone: 0021111626076

Email: [email protected]

Other Identifiers

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CEBC-CU-2016-11-173

Identifier Type: -

Identifier Source: org_study_id