Effect of ProTaper Ultimate System on Post-endodontic Pain

September 2, 2024 updated by: Rania Zaarour, Gulf Medical University

Comparison of Post Endodontic Pain for Preparation Using ProTaper Gold and ProTaper Ultimate Systems. A Randomized Clinical Study

This clinical trial aims to compare the effect of Pro Taper Ultimate and Pro Taper Gold files on post-endodontic pain in molars with symptomatic apical periodontitis.

The main question it aims to answer is:

If there is a difference in post-endodontic pain intensity following root canal preparation using Pro Taper Ultimate and Pro Taper Gold files in molar diagnosed with symptomatic apical periodontitis?

Participants will undergo root canal treatment using Pro Taper Ultimate and Pro Taper Gold files.

Researchers will compare [Pro Taper Ultimate and Pro Taper Gold files] to see the intensity of post-endodontic pain

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will be conducted on 40 first mandibular molars; with 20 first mandibular molars in each group (n=20). The patient will be asked to pick an opaque sealed envelope that will contain a number from 1 to 2. The resultant number will determine in which group the participants will be placed.

Group I: Root canal preparation using Pro Taper Ultimate. Group II: Root canal preparation using Pro Taper Gold.

Procedural steps:

  1. Vitality will be assessed using cold tests and electric pulp testing before the procedure is carried out. Besides, mobility, palpation, and percussion tests will be done to assess periapical health. In order to ensure that the cold and electrical pulp tests are working, and a response is elicited, both tests will be carried out on patients not included in the study.
  2. All the patients will receive local anesthesia: 2% lidocaine with 1:100,000 epinephrine.
  3. Each tooth will be isolated using a rubber dam, and the access cavity will be prepared using a round bur (no.4) and tapered fissure diamond bur under copious water.
  4. After removal of coronal pulp tissues using a sterile excavator, the working length will be determined with stainless steel hand K-files size #10 and the use of an apex locator and confirmed using intraoral periapical radiographs.
  5. Hand instrumentation to 15-size K files.
  6. Group I will be prepared using ProTaper Ultimate files.
  7. Group II will be prepared using ProTaper Gold files.
  8. Apical patency will be maintained throughout the shaping procedure using the #10 file between each instrument.
  9. All the canals will be irrigated with 10 mL of 3% NaOCl between each file during the whole preparation procedure.
  10. All the root canals will be obturated directly after preparation.
  11. All the teeth will be restored using resin composite restoration.

Study Type

Interventional

Enrollment (Actual)

40

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

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patient was diagnosed with symptomatic irreversible pulpits and symptomatic apical periodontitis.
  • 18-70 years old patients
  • Permanent mandibular first molars.
  • Teeth with a fully matured root.
  • Restorable teeth indicated for endodontic treatment.
  • Healthy patients.

Exclusion Criteria:

  • Complex root canal morphology
  • Calcified roots.
  • Teeth with internal and external resorption.
  • Medically compromised patients.
  • Restricted mouth openings (trismus).

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
Experimental: ProTaper Ultimate
Root canal preparation using ProTaper Ultimate files.
Procedure: ProTaper Ultimate
Root canal preparation using ProTaper Ultimate files.
Active Comparator: ProTaper Gold files
Root canal preparation using ProTaper Gold files.
Procedure: ProTaper Gold
Root canal preparation using ProTaper Gold files.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The level of post-endodontic pain
Time Frame: 24 hours
Evaluation of the pain intensity using the Visual Analogue Scale. The Visual Analogue Scale measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could possibly be)
24 hours
The level of post-endodontic pain
Time Frame: 72 hours
Evaluation of the pain intensity using the Visual Analogue Scale. The Visual Analogue Scale measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could possibly be)
72 hours
The level of post-endodontic pain
Time Frame: 1 week
Evaluation of the pain intensity using the Visual Analogue Scale. The Visual Analogue Scale measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could possibly be)
1 week

Collaborators and Investigators

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

Sponsor

Gulf Medical University

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)

September 12, 2022

Primary Completion (Actual)

January 12, 2024

Study Completion (Actual)

July 1, 2024

Study Registration Dates

First Submitted

February 17, 2023

First Submitted That Met QC Criteria

February 17, 2023

First Posted (Actual)

February 28, 2023

Study Record Updates

Last Update Posted (Actual)

September 4, 2024

Last Update Submitted That Met QC Criteria

September 2, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB/COD/STD/33/June-2022

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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