Effect of Removal of Intracanal Medication on Post Operative Pain

March 25, 2020 updated by: Shaimaa Nasr El-deen Abd El-gaffar, Minia University

Post Operative Pain After Removal of Calcium Hydroxide With Different Activation Techniques

Recruited patients with necrotic pulp after application of Calcium hydroxide are assigned to group (XP Endo Finisher file) and group( Passive ultrasonic irrigation) and group (conventional syringe irrigation with side vented needle) to remove intracanal medication and record postoperative pain afterwards.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The investigator will recruit patients who are found eligible to the criteria, Calcium hydroxide will be inserted inside the canals. After 7 days, patients will be randomly assigned to either removal of intracanal medication using, the XP-Endo Finisher file, passive ultrasonic irrigation (PUI) and conventional syringe irrigation with side vented needle.

After the visit, patients will be asked to record post operative pain by Visual Analog Scale)in a given sheet

Study Type

Interventional

Enrollment (Anticipated)

30

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

  • Name: Shaimaa Nasr El-din Abd El-Ghaffar, PHD
  • Phone Number: +0201020271788
  • Email: dr_shimes@hotmail.com

Study Locations

  • Egypt
      • Minya, Egypt
        • Recruiting
        • Faculty of Oral and dental medicine, Minia University

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

20 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Medically free patients.
  • Patient's age between 20-50 years.
  • Both sexes.
  • Necrotic pulp as indicated by thermal or electric pulp testing.
  • No history of previous endodontic treatment of the tooth.
  • Enough crown structure for adequate isolation.

Exclusion Criteria:

  • Pregnancy or lactation
  • Medically compromised patients
  • Previous endodontic therapy of the affected tooth.
  • Teeth diagnosed with vital pulp.
  • Teeth with periodontal pocket more than 3mm deep.
  • Teeth with abnormal anatomy or calcified canals.
  • Teeth with caries below the bony level (non-restorable tooth).
  • Immature teeth with open apices.

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: XP-endo Finisher file
removal of calcium hydroxide intracanal medication with XP-endo Finisher file
Device: Calcium hydroxide with XP-endo Finisher file
XP-endo Finisher files (FKG Dentaire, La Chaux-de-Fonds, Switzerland). file will be used with an endodontic motor X-Smart (Dentsply Sirona, Ballaigues, Switzerland) in removal of calcium hydroxide
EXPERIMENTAL: Irrisafe Ultrasonic tip
removal of calcium hydroxide intracanal medication with passive ultrasonic irrigation
Device: Calcium hydroxide with Irrisafe Ultrasonic tip
passive ultrasonic irrigation (PUI) with an IrriSafe Ultrasonic tips (Acteon,France), which will be driven by an ultrasonic device (Newtron P5, Satelec, Acteongroup, Merignac, France) in reemoval of calcium hydroxide
Other Names:
  • passive ultrasonic irrigation
ACTIVE_COMPARATOR: side vented needle
removal of calcium hydroxide intracanal medication with conventional syringe irrigation
Device: Calcium hydroxide with side vented needle
conventional syringe irrigation with side vented needle (prime Dent, India) in removal of calcium hydroxide
Other Names:
  • conventional syringe irrigation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in post operative pain (Visual Analogue Scale)
Time Frame: Intrappointment at 4,24,48,72 and 96 hours
Numerical (0-10)
Intrappointment at 4,24,48,72 and 96 hours

Collaborators and Investigators

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

Sponsor

Minia 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 (ANTICIPATED)

April 1, 2020

Primary Completion (ANTICIPATED)

June 1, 2020

Study Completion (ANTICIPATED)

October 1, 2020

Study Registration Dates

First Submitted

March 24, 2020

First Submitted That Met QC Criteria

March 25, 2020

First Posted (ACTUAL)

March 27, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 27, 2020

Last Update Submitted That Met QC Criteria

March 25, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 311

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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