Effect of Apical Enlargement to Different Preparation Sizes and Tapers on Pain and Bacterial Reduction in Necrotic Pulp

November 16, 2022 updated by: Nermeen AwadAllah Abbas Ibrahim, Cairo University

Effect of Apical Third Enlargement to Different Preparation Sizes and Tapers of EdgeFile X7 on Postoperative Pain and Intra-canal Bacterial Reduction in Patients With Necrotic Pulp: A Randomized Clinical Trial

The aim of this prospective randomized clinical trial is to evaluate the effect of different apical size and taper preparation (35. 04; 35. 06; 45. 04 and 45. 06) on postoperative pain at 6, 12, 24, 48 and 72 hours, and intra-canal bacterial count in patients having mandibular premolars with necrotic pulps.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

  • Patients will be clinically and radiographically examined and their eligibility will be assessed. Eligible patients will be treated in one visit.
  • Patients will be randomly assigned to one of 4 groups: experimental groups of root canal instrumentation with EdgeFile X7 to size #35/0.06 or #45/0.04 or #45/0.06 or the comparator group to size #35/0.04. Intra-canal bacterial count will be measured using a culture technique. Bacterial samples will be taken before and after root canal instrumentation. After endodontic treatment, patients will be given postoperative instructions and informed, in case of pain, to receive ibuprofen 400 mg as rescue medication.
  • Postendodontic pain intensity and incidence at the different pain categories (No, mild, moderate, severe) will be assessed at 6, 12, 24, 48 and 72 hours postoperatively using Numerical Rating Scale (NRS).

Study Type

Interventional

Enrollment (Anticipated)

56

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

16 years to 33 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Systemically healthy patients, American Society of Anesthesiologists (ASA) I and II.
  • Patient's age ranges between 18 to 35 years with no sex predilection.
  • Patients with single-rooted mandibular premolars with asymptomatic necrotic pulp.
  • Patients who can understand the Numerical Rating Scale (NRS).
  • Patients able to sign informed consent.

Exclusion Criteria:

  • Pregnant females.
  • Mandibular premolars with periodontal pockets greater than 5 mm or greater than grade I mobility.
  • Patients have a positive history of antibiotic use or analgesic use within the past week or required antibiotic premedication for dental treatment (such as prosthetic joint prophylaxis).
  • Patients have teeth that have been previously accessed.
  • Teeth with extensive crown destruction by caries that will not permit rubber dam placement.
  • Teeth associated with acute periapical abscess, swelling or a fistulous tract.
  • 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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Root canal instrumentation EdgeFile X7 to size #35/0.06
The mechanical preparation will be continued using EdgeFile X7 #35 .04 and #35 .06
Other: Root canal instrumentation EdgeFile X7 to size #35/0.06
Instrumentation will be performed using an endodontic motor at a speed of 300 rpm and a torque of 2 Ncm
Other Names:
  • EdgeEndo
Experimental: Root canal instrumentation EdgeFile X7 to size #45/0.04
The mechanical preparation will be continued using EdgeFile X7 #35 .04, #40 .04 and #45 .04
Other: Root canal instrumentation EdgeFile X7 to size #45/0.04
Instrumentation will be performed using an endodontic motor at a speed of 300 rpm and a torque of 2 Ncm
Other Names:
  • EdgeEndo
Experimental: Root canal instrumentation EdgeFile X7 to size #45/0.06
The mechanical preparation will be continued using EdgeFile X7 #35 .04, #40 .04, #45 .04 and #45 .06
Other: Root canal instrumentation EdgeFile X7 to size #45/0.06
Instrumentation will be performed using an endodontic motor at a speed of 300 rpm and a torque of 2 Ncm
Other Names:
  • EdgeEndo
Active Comparator: Root canal instrumentation EdgeFile X7 to size #35/0.04
The mechanical preparation will be continued using EdgeFile X7 #35 .04
Other: Root canal instrumentation EdgeFile X7 to size #35/0.04
Instrumentation will be performed using an endodontic motor at a speed of 300 rpm and a torque of 2 Ncm
Other Names:
  • EdgeEndo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative pain
Time Frame: up to 72 hours after endodontic treatment
Postendodontic pain will be measured using Numerical Rating Scale. The Numerical Rating Scale consists of a 0-10 scale, with (0) meaning "no pain" and (10) meaning "the worst pain imaginable". No or mild pain response will be considered success.
up to 72 hours after endodontic treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intra-canal bacterial reduction
Time Frame: Bacterial samples will be taken Immediately after root canal instrumentation.
Intra-canal bacterial count will be measured using a culture technique. The resultant growth will be visually quantified by counting the number of colony forming units per millilitre (CFUs/ mL)
Bacterial samples will be taken Immediately after root canal instrumentation.

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Principal Investigator: Nermeen Ibrahim, Master's, Misr University for Science and Technology

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)

January 1, 2023

Primary Completion (Anticipated)

November 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

November 2, 2022

First Submitted That Met QC Criteria

November 8, 2022

First Posted (Actual)

November 17, 2022

Study Record Updates

Last Update Posted (Actual)

November 21, 2022

Last Update Submitted That Met QC Criteria

November 16, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2/11/2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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.

Clinical Trials on Necrotic Pulp

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Austria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe