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Effect Of XP Endo Finisher Versus Ultrasonic Activated Irrigation On Post-operative Pain In Endodontic Treatment of Symptomatic Irreversible Pulpitis (RCT)

Primary Purpose

Symptomatic Irreversible Pulpitis

Status

Unknown status

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

XP Endo Finisher

ultrasonic activated irrigation

About this trial

This is an interventional treatment trial for Symptomatic Irreversible Pulpitis focused on measuring XP Endo Finisher, ultrasonic activated irrigation, postoperative pain

Eligibility Criteria

25 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Medically- free of any systemic disease
Male or female
Patients with age range 25-45
Symptomatic irreversible pulpitis in single rooted single canal teeth without apical periodontitis.
Teeth with mature root
Restorable teeth
Teeth without calcified root canals
Teeth without root caries
Teeth without internal or external root resorption
Teeth with no sign of crack formation
Teeth without anatomic abnormalities

Exclusion Criteria:

Pregnant females.
If analgesics have been administrated during the past two weeks preoperatively.
Patients having bruxism or clenching.
Multi rooted or multi canaled teeth.
Patients with swelling or acute peri-apical abscess.
Previously endodontically treated teeth
periodontally affected teeth .

Sites / Locations

Faculty of Oral and dental medicine, Cairo UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

XP Endo Finisher file

ultrasonic activated irrigation

Arm Description

XP Endo Finisher file is used to activate irrigation as a final step in irrigation protocol

ultrasonic activated irrigation as a final step in irrigation protocol

Outcomes

Primary Outcome Measures

post-operative pain

measured by NRS (Numerical rate scale)

Secondary Outcome Measures

Number of taken analgesic tablets

counted by the patient and recorded in a given chart

Full Information

NCT ID

NCT03096587

First Posted

March 25, 2017

Last Updated

August 21, 2017

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT03096587

Brief Title

Effect Of XP Endo Finisher Versus Ultrasonic Activated Irrigation On Post-operative Pain In Endodontic Treatment of Symptomatic Irreversible Pulpitis

Acronym

RCT

Official Title

Effect Of Using XP Endo Finisher Versus Ultrasonic Activated Irrigation On Post-operative Pain In Single Visit Endodontic Treatment of Teeth With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Unknown status

Study Start Date

April 15, 2017 (Actual)

Primary Completion Date

April 2018 (Anticipated)

Study Completion Date

April 2018 (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

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

Recruited patients with symptomatic irreversible pulpitis are assigned to interventional (XP Endo Finisher file) and control group(ultrasonic activated irrigation) to undergo single visit endodontic treatment and record postoperative pain afterwards.

Detailed Description

The investigator will recruit patients from the clinic of endodontics in faculty of oral and dental medicine, Cairo university. The patients who are found eligible to the criteria, will be randomly assigned to either the control group (ultrasonic activated irrigation )or to the intervention group( XP Endo-Finisher file). Endodontic treatment will be done in single visit. After the visit, patients will be asked to record post operative pain by NRS (Numerical Rate Scale)in a given sheet.

6. Conditions and Keywords

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

Symptomatic Irreversible Pulpitis

Keywords

XP Endo Finisher, ultrasonic activated irrigation, postoperative pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Masking Description

The patient will be blinded and will not know the group he is in.

Allocation

Randomized

Enrollment

44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

XP Endo Finisher file

Arm Type

Experimental

Arm Description

XP Endo Finisher file is used to activate irrigation as a final step in irrigation protocol

Arm Title

ultrasonic activated irrigation

Arm Type

Active Comparator

Arm Description

ultrasonic activated irrigation as a final step in irrigation protocol

Intervention Type

Device

Intervention Name(s)

XP Endo Finisher

Intervention Description

a flexible single use NiTi file with small diameter and no taper, changes from straight M-phase to A-phase in body temperature

Intervention Type

Device

Intervention Name(s)

ultrasonic activated irrigation

Other Intervention Name(s)

Irrisafe

Intervention Description

by Satelec,Acteon, France

Primary Outcome Measure Information:

Title

post-operative pain

Description

measured by NRS (Numerical rate scale)

Time Frame

up to 1 week after the visit

Secondary Outcome Measure Information:

Title

Number of taken analgesic tablets

Description

counted by the patient and recorded in a given chart

Time Frame

within a week after the visit

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Medically- free of any systemic disease Male or female Patients with age range 25-45 Symptomatic irreversible pulpitis in single rooted single canal teeth without apical periodontitis. Teeth with mature root Restorable teeth Teeth without calcified root canals Teeth without root caries Teeth without internal or external root resorption Teeth with no sign of crack formation Teeth without anatomic abnormalities Exclusion Criteria: Pregnant females. If analgesics have been administrated during the past two weeks preoperatively. Patients having bruxism or clenching. Multi rooted or multi canaled teeth. Patients with swelling or acute peri-apical abscess. Previously endodontically treated teeth periodontally affected teeth .

Central Contact Person:

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

Nouran A Hany, BDS

Phone

+2 01223626996

nouranhany11@hotmail.com

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

Shaimaa I Gawdat, PHD

Phone

+2 01222235502

shaimaagawdat@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nouran A Hany, BDS

Organizational Affiliation

Department of endodontics -Faculty of Oral and Dental Medicine-Cairo university

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Shaimaa I Gawdat, PHD

Organizational Affiliation

Department of endodontics -Faculty of Oral and Dental Medicine-Cairo university

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Hebatallah M El-Far, Professor

Organizational Affiliation

Department of endodontics -Faculty of Oral and Dental Medicine-Cairo university

Official's Role

Study Chair

Facility Information:

Facility Name

Faculty of Oral and dental medicine, Cairo University

City

Cairo

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nouran A Hany, BDS

Phone

+2 01223626996

nouranhany11@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

27641947

Citation

Alves FR, Andrade-Junior CV, Marceliano-Alves MF, Perez AR, Rocas IN, Versiani MA, Sousa-Neto MD, Provenzano JC, Siqueira JF Jr. Adjunctive Steps for Disinfection of the Mandibular Molar Root Canal System: A Correlative Bacteriologic, Micro-Computed Tomography, and Cryopulverization Approach. J Endod. 2016 Nov;42(11):1667-1672. doi: 10.1016/j.joen.2016.08.003. Epub 2016 Sep 15.

Results Reference

result

PubMed Identifier

27248848

Citation

Middha M, Sangwan P, Tewari S, Duhan J. Effect of continuous ultrasonic irrigation on postoperative pain in mandibular molars with nonvital pulps: a randomized clinical trial. Int Endod J. 2017 Jun;50(6):522-530. doi: 10.1111/iej.12666. Epub 2016 Jun 28.

Results Reference

result

PubMed Identifier

25598754

Citation

Sadaf D, Ahmad MZ. Factors associated with postoperative pain in endodontic therapy. Int J Biomed Sci. 2014 Dec;10(4):243-7.

Results Reference

result

Learn more about this trial

Effect Of XP Endo Finisher Versus Ultrasonic Activated Irrigation On Post-operative Pain In Endodontic Treatment of Symptomatic Irreversible Pulpitis

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