Post-Operative Pain Evaluation After Using Different Single-file Root Canal Preparation System: A Randomized Clinical Study

January 5, 2024 updated by: Abdel Moneim Ahmed Elkalashy, Tanta University
The goal of this clinical trial is to assess post-operative pain following root canal preparation using various single-file systems

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The goal of this clinical trial is to assess post-operative pain following root canal preparation using various single-file systems.Postoperative pain assessment was done by an independent evaluator with no knowledge of the group under investigation. The visual Analogue Scale (VAS) was employed. Patients could put a mark anywhere on the VAS sheet with values ranging from 0 to 100 mm [10].

  • Score 0: No pain (between 0 and 4 mm) the tooth after treatment felt normal, and no discomfort was reported by the patients.
  • Score 1: Recognizable, mild pain (between 5 and 44 mm), not requiring analgesics.
  • Score 2: Moderate pain (between 45 and 74 mm) that is uncomfortable but bearable (when analgesics were taken, the pain was successfully reduced).
  • Score 3: Severe pain (between 75 and 100 mm) painful to endure (pain was not relieved by taking analgesics).

The patients in this study were not aware of the preparation system used during treatment. Following treatment, three readings were taken at 24, 72, and 7 days. Each patient carried a VAS form, and reminder calls were made to record pain levels and return the form filled out completely

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
    • Gharbia Governorate
      • Tanta, Gharbia Governorate, Egypt, 31773
        • Faculty of Dentistry, Tanta University, Egypt

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • • Teeth with a single root canal with nearly the same apical diameter (#15)

    • Vital pulp exposures due to caries or trauma with asymptomatic pulpitis
    • Restorable teeth

Exclusion Criteria:

  • • Patients with immune deficiencies or systemic illnesses

    • Pregnant women
    • Cases of re-treatment
    • Symptomatic non-vital teeth that require root canal therapy
    • Presence of root resorption
    • Teeth with anatomic variations
    • A cute periapical abscess cases with pus discharge
    • A patient who has several teeth that need to be treated in order to eliminate the likelihood of pain referral
    • Periodontal diseases
    • Patients on analgesics, anti-inflammatory drugs, sedatives, or antibiotics seven days before therapy

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Hyflex EDM
Hyflex EDM One File (25/) with variable taper was used in continuous rotation at 500 rpm and 2.5 Ncm in a circumferential brushing action in the coronal and middle thirds, then in a pecking action for three to five cycles until the WL was reached.
Device: Hyflex EDM , The XP-endo Shaper, Primary WaveOne Gold
rotary single files
Active Comparator: The XP-endo Shaper
The XP-endo Shaper (30/0.01) was used in rotation mode at 800 rpm and 1.0 Ncm torque. Long, gentle strokes with amplitudes of 3-4 mm were used to go down to adjusted WL in three to five cycles. After it reached the WL over the adjusted WL, it was subjected to five more up-and-down motions.
Device: Hyflex EDM , The XP-endo Shaper, Primary WaveOne Gold
rotary single files
Active Comparator: Primary WaveOne Gold
Primary WaveOne Gold (25/07) was applied three times in a reciprocating motion; a gradual in-and-out pecking movement was utilized as directed by the manufacturer till the WL was reached.
Device: Hyflex EDM , The XP-endo Shaper, Primary WaveOne Gold
rotary single files

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Postoperative pain evaluation
Time Frame: 24 hours to 7 days
Postoperative pain assessment was done by an independent evaluator with no knowledge of the group under investigation. The visual Analogue Scale (VAS) was employed. Patients could put a mark anywhere on the VAS sheet with values ranging from 0 to 100 mm [10]. • Score 0: No pain (between 0 and 4 mm) the tooth after treatment felt normal, and no discomfort was reported by the patients. • Score 1: Recognizable, mild pain (between 5 and 44 mm), not requiring analgesics. • Score 2: Moderate pain (between 45 and 74 mm) that is uncomfortable but bearable (when analgesics were taken, the pain was successfully reduced). • Score 3: Severe pain (between 75 and 100 mm) painful to endure (pain was not relieved by taking analgesics). The patients in this study were not aware of the preparation system used during treatment. Following treatment, three readings were taken at 24, 72, and 7 days. Each patient carried a VAS form, and reminder calls were made to record pain levels and return the form fill
24 hours to 7 days

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tanta University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Abdel Moneim A. Elkalashy, Assis.lecturer, Assis.lecturer at endodontic department

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 30, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 11, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 5, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 5, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 16, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • #R-END-1-20-5

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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