Can Instrumentation Kinematics Affect Post Operative Pain and Substance P Levels? A Randomized Controlled Trial

November 13, 2023 updated by: Salma Talaat, Ain Shams University
The aim of this study was to evaluate the effect of continuous rotation and reciprocation kinematics on post operative pain and difference in substance P levels in patients with irreversible pulpitis with symptomatic apical periodontitis. Twenty patients were randomly distributed into two groups; Continuous Rotation group(n=10): received mechanical preparation using EdgeEndo x7 rotary system (Albuquerque, New Mexico, USA), while Reciprocation group(n=10): received mechanical preparation using EdgeOne Fire reciprocating system (Albuquerque, New Mexico, USA). Apical fluid(AF) samples were collected, and substance P (SP) levels were measured using radioimmunoassay and postoperative pain was measured using Numerical Rating Scale (NRS) preoperatively, at 6h, 12h, 24h, 48h and 72h.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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, 11765
        • Ain shams university
    • Select A State Or Province
      • Cairo, Select A State Or Province, Egypt, 11765
        • 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:

  • Single rooted mandibular second premolar teeth with complete root formation
  • Pulpal diagnosis: Symptomatic irreversible pulpitis
  • Periapical diagnosis: symptomatic apical periodontitis with no visible periapical radiolucent area
  • Patients with pre-operative pain records above 4 on Numerical Rating Scale (NRS) to ensure standardization

Exclusion Criteria:

  1. The presence of any systemic disease or allergic reactions
  2. Pregnant and lactating females
  3. Patients on antibiotic or anti-inflammatory medication
  4. Use of analgesics a week prior to treatment
  5. A radiographically untraceable canal or an excessively curved root
  6. The presence of periapical radiolucency or sinus tract.
  7. Teeth with open apices
  8. Severe periodontal disease (generalized or localized to the tooth in question)
  9. Absence of bleeding in the pulp chamber on access cavity preparation
  10. Internal or external resorption

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: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Continuous Rotation group
EdgeEndo x7 continuous rotation files system (Albuquerque, New Mexico, USA)
Device: EdgeEndo x7 continuous rotation files
endodontic files operating in continuous rotation
Active Comparator: Reciprocation group
EdgeOne Fire reciprocating files system (Albuquerque, New Mexico, USA)
Device: EdgeOne Fire reciprocating files
endodontic files operating in reciprocating motion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
difference in substance P levels
Time Frame: pre-operatively and after 5 days at the beginning of the second visit
tested by radioimmunacy (ELISA)
pre-operatively and after 5 days at the beginning of the second visit
post operative pain levels
Time Frame: pre-operative, after 6 hours, 12 hours , 24 hours, 48 hours, 72 hours
Numerical Rating Scale was used to assess pain where 0 is no pain and 10 is the worst possible pain
pre-operative, after 6 hours, 12 hours , 24 hours, 48 hours, 72 hours

Collaborators and Investigators

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

Sponsor

Ain Shams University

Investigators

  • Study Chair: maram obeid, PROFESSOR

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)

March 15, 2023

Primary Completion (Actual)

April 5, 2023

Study Completion (Actual)

June 5, 2023

Study Registration Dates

First Submitted

September 25, 2023

First Submitted That Met QC Criteria

October 11, 2023

First Posted (Actual)

October 13, 2023

Study Record Updates

Last Update Posted (Actual)

November 15, 2023

Last Update Submitted That Met QC Criteria

November 13, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 945

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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