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Postoperative Pain Associated With Three Endodontic Rotary Systems

Primary Purpose

Acute Pulpitis

Status

Unknown status

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

ONE ENDO

F6 SKYTaper

ProTaper Universal

About this trial

This is an interventional treatment trial for Acute Pulpitis focused on measuring single file., ONE ENDO., F6 SkyTaper., ProTaper Universal., irreversible pulpitis., postoperative pain.

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Faculty of Oral and Dental Medicine - Cairo UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

ONE ENDO

F6 SKYTaper

ProTaper Universal

Arm Description

Single file rotary system

Muti-file rotary system

Outcomes

Primary Outcome Measures

postoperative pain

Verbal Rating Scale (VRS) with the following scores: 0. No pain. Mild pain: any discomfort of any duration that does not require analgesics. Moderate pain: pain that requires and is relieved with analgesics. Severe pain: any pain that is not relieved with analgesics.

Secondary Outcome Measures

Number of analgesics consumed

Full Information

NCT ID

NCT03065777

First Posted

February 15, 2017

Last Updated

February 22, 2017

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT03065777

Brief Title

Postoperative Pain Associated With Three Endodontic Rotary Systems

Official Title

Evaluation of Postoperative Pain After Single Visit Root Canal Treatment Associated With The Three Rotary Systems; ONE ENDO, F6 SkyTper and ProTaper Universal. (Randomized Controlled Clinical Trial)

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Unknown status

Study Start Date

October 2016 (Actual)

Primary Completion Date

August 2017 (Anticipated)

Study Completion Date

December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Pulpitis

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

57 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ONE ENDO

Arm Type

Experimental

Arm Description

Single file rotary system

Arm Title

F6 SKYTaper

Arm Type

Experimental

Arm Description

Single file rotary system

Arm Title

ProTaper Universal

Arm Type

Active Comparator

Arm Description

Muti-file rotary system

Intervention Type

Device

Intervention Name(s)

ONE ENDO

Intervention Description

single file rotary system

Intervention Type

Device

Intervention Name(s)

F6 SKYTaper

Intervention Description

single file rotary system

Intervention Type

Device

Intervention Name(s)

ProTaper Universal

Intervention Description

multi-file rotary system

Primary Outcome Measure Information:

Title

postoperative pain

Description

Time Frame

up to 72 hours after endodontic treatment

Secondary Outcome Measure Information:

Title

Number of analgesics consumed

Time Frame

up to 72 hours after endodontic treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ola A. Hafez, MD Student

Phone

0021111626076

olahafez2010@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ola A. Hafez, MD Student

Organizational Affiliation

Faculty of Oral and Dental Medicine - Cairo University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Alaa El-Din H. Diab, Professor

Organizational Affiliation

Faculty of Oral and Dental Medicine - Cairo University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Kareem G. Abd El-Kader, Assistant Professor

Organizational Affiliation

Faculty of Oral and Dental Medicine - Cairo University

Official's Role

Study Director

Facility Information:

Facility Name

Faculty of Oral and Dental Medicine - Cairo University

City

Cairo

Country

Egypt

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

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Postoperative Pain Associated With Three Endodontic Rotary Systems

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