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

August 21, 2017 updated by: Nouran Ahmed Hany Asal, Cairo University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Faculty of oral and dental medicine, Cairo university
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: XP Endo Finisher file
XP Endo Finisher file is used to activate irrigation as a final step in irrigation protocol
Device: XP Endo Finisher
a flexible single use NiTi file with small diameter and no taper, changes from straight M-phase to A-phase in body temperature
Active Comparator: ultrasonic activated irrigation
ultrasonic activated irrigation as a final step in irrigation protocol
Device: ultrasonic activated irrigation
by Satelec,Acteon, France
Other Names:
  • Irrisafe

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
post-operative pain
Time Frame: up to 1 week after the visit
measured by NRS (Numerical rate scale)
up to 1 week after the visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of taken analgesic tablets
Time Frame: within a week after the visit
counted by the patient and recorded in a given chart
within a week after the visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Nouran A Hany, BDS, Department of endodontics -Faculty of Oral and Dental Medicine-Cairo university
  • Study Director: Shaimaa I Gawdat, PHD, Department of endodontics -Faculty of Oral and Dental Medicine-Cairo university
  • Study Chair: Hebatallah M El-Far, Professor, Department of endodontics -Faculty of Oral and Dental Medicine-Cairo university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2017

Primary Completion (Anticipated)

April 1, 2018

Study Completion (Anticipated)

April 1, 2018

Study Registration Dates

First Submitted

March 25, 2017

First Submitted That Met QC Criteria

March 25, 2017

First Posted (Actual)

March 30, 2017

Study Record Updates

Last Update Posted (Actual)

August 22, 2017

Last Update Submitted That Met QC Criteria

August 21, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEBC-CU-2017-03-19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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