Postoperative Pain Assessment After Canal Preparation by Different NiTi File Systems

February 24, 2024 updated by: Fatma Essam Badr El-din, Bachelor, Ain Shams University

Postoperative Pain Assessment After Canal Preparation by Different NiTi File Systems (A Randomized Clinical Trial)

The participants were divided into two groups : group one ( Trunatomy file group)(n=10) was mechanically prepared the canals by Trunatomy file and group two ( Edgeendo x7 file group) ( n=10) was prepared the canals by Edgeendo x7 file, the participants were assessed pain preoperatively and postoperatively by Visual Analog Scale(VAS)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients : 20 patients with symptomatic apical periodontitis related to mandibular premolars were selected.after proper anathesia, Access cavity was ppreformed.The working length measured using apex locator.chemomechanical preparation was done .for trunatomy file group ,using file sequence according to manufacture's instructions until medium one .for edgeendo group ,using file sequence also according to manufacture's instructions until file size 35 taper4.Apical fluid samples was collected by paper point from the both preoperatively and before obturation and also pain was assessed pre and post opertively.finally,the root canal were filled by gutta-percha and resin based sealer.the access cavity was restored by glass ionomer restoration.

Study Type

Interventional

Enrollment (Actual)

20

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 Locations

  • Egypt
      • Cairo, Egypt
        • Ain Shams 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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • clinical diagnoses of apical periodontitis related to single-rooted mandibular premolars
  • no evidence of excessive mobility

Exclusion Criteria:

  • presence of any systemic disease or allergic reaction
  • Incompletely formed root
  • Previously Endodontically treated 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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Trunatomy file group
Using trunatomy file for chemomechanical preparation for root canal of mandibular premolars
Procedure: Chemomechanical preparation for root canals
After working length determination ,root canal preparation was made by two different NiTi File systems to both group ( the first group using Trunatomy file and the second one using edgeendo x7 file) and assessment of pain was made preoperatively and postoperatively and also apical fluid samples
Other Names:
  • Root canal treatment
Active Comparator: Edgeendo x7 file group
Using edgeendo x7 file for chemomechanical preparation for root canal of mandibular premolars
Procedure: Chemomechanical preparation for root canals
After working length determination ,root canal preparation was made by two different NiTi File systems to both group ( the first group using Trunatomy file and the second one using edgeendo x7 file) and assessment of pain was made preoperatively and postoperatively and also apical fluid samples
Other Names:
  • Root canal treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of post operative pain using 10-cm visual analogue scale ( VAS)
Time Frame: After 6 hours,24 hours, 48 hours and finally 72 hours
10-cm visual analogue scale (VAS) questionnaire.each patient reported their level of pain as follow: 0 no pain,1-3 mild pain,4-6 moderate pain,7-9 severe pain and 10 the worst pain
After 6 hours,24 hours, 48 hours and finally 72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of inflammatory mediators substance P in apical fluid samples
Time Frame: Preoperatively ( after working length determination) and before obturation after 3days
Sample were obtained by paper point size 25passing 2mm beyond the apex where they were soaked in the periapical interstitial fluid for 1minute .four mm from tip of paper point we're cut and dropped into 1,5ml Eppendorf tubes ( Swanscombe,UK) with 1ml of phosphate buffered saline,then restored at -80 to be measured by ELISA test
Preoperatively ( after working length determination) and before obturation after 3days

Collaborators and Investigators

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

Sponsor

Ain Shams University

Investigators

  • Study Director: Maram F Obeid, Professor, Faculty of dentistry, ain shams 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

Helpful Links

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)

October 14, 2023

Primary Completion (Actual)

January 29, 2024

Study Completion (Actual)

February 14, 2024

Study Registration Dates

First Submitted

February 24, 2024

First Submitted That Met QC Criteria

February 24, 2024

First Posted (Estimated)

February 29, 2024

Study Record Updates

Last Update Posted (Estimated)

February 29, 2024

Last Update Submitted That Met QC Criteria

February 24, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6280

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Detailed statistical analysis plan

IPD Sharing Time Frame

2025, available for a year

IPD Sharing Access Criteria

Review the purpose of request

IPD Sharing Supporting Information Type

  • SAP

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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