Assessment of Postoperative Pain and Bacterial Load Reduction After Using TruNatomy and ProTaper Next Rotary Systems in Patients With Necrotic Mandibular Molars: A Randomized Clinical Trial

April 23, 2021 updated by: yasmin hamdy hussien, Cairo University
This study aims to assess the effect of rotary instrumentation using ProTaper Next rotary system versus TruNatomy rotary system on postoperative pain and the bacterial load reduction following single visit root canal treatment in necrotic mandibular molars.

Study Overview

Status

Not yet recruiting

Detailed Description

In the last years several rotary systems had launched to the market for mechanical preparation. The new era in the mechanical instrumentation aims to preserve the maximum amount of the peri-cervical dentine without affecting the proper cleaning and bacterial elimination. This will improve the long-term survival of the tooth with appropriate removal of microbes and microbial irritants.

ProTaper Next is a rotary system made from M wire. It is characterized by an innovative off-centered rectangular cross section that is suggested to give the files a snake-like swaggering movement as it advances into the root canal. This movement minimizes the engagement between the file and dentin and improves extruding debris out of the canal.

TruNatomy (Dentsply Sirona), is recently introduced as a new generation of rotary file system. TruNatomy files are designed to shape root canal systems to a continuously tapering preparation with maximum preservation of peri-cervical dentine. TruNatomy system offers a more safety, simplicity, improved cutting efficiency and mechanical properties compared to previous generations of rotating instruments, Many researches had been conducted to address the effect of ProTaper Next on post-operative pain considering it the most commonly used system. Thus, this study will be performed to evaluate and compare the influence of using the two systems on the intensity of postoperative pain and bacterial load reduction.

Study Type

Interventional

Enrollment (Anticipated)

34

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

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

22 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • - Medically free patients.
  • Mandibular permanent molar teeth:
  • Diagnosed clinically with pulp necrosis.
  • Absence of spontaneous pain.
  • Slight widening in the periodontal membrane space or with periapical radiolucency
  • Patient's age ranges between 22 to 45 years with no sex predilection.
  • Patients who can understand Modified Visual Analogue Scale (VAS).
  • Patients' acceptance to participate in the trial.
  • Patients able to sign informed consent.

Exclusion Criteria:

  • - Medically compromised patients: Pain levels and healing following treatment would be compromised as these patients have shown higher incidence of pain and lower healing rate.
  • Pregnant women: Avoid radiation exposure, anesthesia, and medication.
  • If analgesics or antibiotics have been administrated by the patient during the past 24 hours preoperatively might alter their pain perception.
  • Patients reporting bruxism or clenching: Avoid further pressure on an already inflamed tooth inducing subsequent irritation and inflammation.
  • Teeth that show association with acute periapical abscess and swelling: Need special treatment steps which could involve additional visits with incision and drainage. Also, it could influence initiation and progression of postoperative pain.
  • Greater than grade I mobility or pocket depth greater than 5mm. Need special surgical and/or periodontal therapy.
  • No restorability: Hopeless tooth.
  • Vital teeth.
  • Immature teeth.
  • Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.

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: ProTaper Next rotary file system (Dentsply Sirona)
the mechanical preparation will be performed using rotary file system
Experimental: TruNatomy rotary system (Dentsply Sirona)
the mechanical preparation will be performed using rotary file system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intensity of postoperative pain
Time Frame: 48 hours

Postoperative pain will be measured by modified VAS at 6, 12, 24 and 48 hours post-obturation.

The modified VAS consists of from 0-10 point scale anchored by two extremes "No pain" and "pain as bad as could be". The patients will be asked to choose the mark on an appendix that represents their level of pain. Pain level will be assigned to one of four categorical scores:

  1. None (0)
  2. Mild (1-3)
  3. Moderate (4-6)
  4. Severe (7-10) numerical rating scale (NRS) at 6, 12, 24 and 48 hours post-obturation and at 6, 12, 24 and 48 hours post-obturation.
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bacterial load reduction
Time Frame: 24 hours
Bacterial load reduction will be determined by bacterial counting using agar culture technique after root canal preparation (CFU/ml).
24 hours

Collaborators and Investigators

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

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)

September 1, 2021

Primary Completion (Anticipated)

August 1, 2022

Study Completion (Anticipated)

September 1, 2022

Study Registration Dates

First Submitted

October 14, 2020

First Submitted That Met QC Criteria

April 23, 2021

First Posted (Actual)

April 28, 2021

Study Record Updates

Last Update Posted (Actual)

April 28, 2021

Last Update Submitted That Met QC Criteria

April 23, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • ENDO:3-3-5

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

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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