The Effect of Totalfil and Neosealer Sealers on the Post-endodontic Pain

March 13, 2025 updated by: Rania Zaarour, Gulf Medical University

Evaluation of the Effect of Totalfil and Neosealer Sealers on the Post-endodontic Pain in Mandibular Molars Diagnosed With Symptomatic Irreversible Pulpitis; a Randomized Control Study.

The goal of this clinical trial is to evaluate the effect of Totalfil and Neosealer sealers on post-endodontic pain compared to AH plus sealer in mandibular molars with symptomatic irreversible pulpitis. The main question: do Totalfil and Neosealer sealers affect postoperative pain intensity after root canal treatment in mandibular molars with symptomatic irreversible pulpitis? Participants will undergo root canal treatment using totalfil, Neosealer, or AH-Plus sealer. Researchers will compare Totalfil, Neosealer, and AH-Plus to assess the intensity of post-endodontic pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will be conducted on 39 mandibular molars; with 13 mandibular mandibular molars in each group (n=13). The patient will be asked to pick an opaque sealed envelope that will contain a number from 1 to 3. The resultant number will determine in which group the participants will be placed. Double blinding will be maintained in this study as the assessor and the patients will not be aware of their group/used root canal sealer.

Group I: Endodontic treatment with obturation using single cone technique with Totalfil sealer.

Group 2: Endodontic treatment with obturation using single cone technique with Neosealer.

Group 3: Endodontic treatment with obturation using single cone technique with AH plus sealer.

Clinical procedure:

  1. Patient history will be recorded before starting the procedure.
  2. The consent form will be given and signed by the patient.
  3. Pre-operative pain will be assessed using VAS.
  4. Tooth diagnosis will take place through visualization, percussion, palpation, mobility, electric pulp test as well as cold test before the treatment begins.
  5. Pre-operative radiograph will be taken to confirm diagnosis.
  6. All the patients will receive local anesthesia: 2% lidocaine with 1:100,000 epinephrine. The inferior alveolar nerve block will be administered.
  7. A single 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 stone (NO173).
  8. The saliva ejector will be introduced below the integrated frame and will be positioned in the corner of the mouth.
  9. De-roofing of the pulp chamber will be done using Endo Z bur.
  10. After removal of the pulp tissue using an H-file, 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.
  11. All the canals will be prepared using Protaper Gold rotary system using NSK endodontic motor, according to the manufacturer guidelines.
  12. To establish apical patency between the files during shaping we will use initial file size #10 between each instrument.
  13. Each canal will be irrigated with 30 mL 3% NaOCl and flushed with saline 10 mL between each file during the whole preparation procedure using a plastic syringe with a side vented needle.
  14. After completion of cleaning and shaping in all the canals will be flushed with a final rinse of NaOCl, saline and EDTA 17%.
  15. For group 1, the canals will be moist and obturated using the single cone technique by gutta percha using Totalfill as a sealer.
  16. For group 2, the canals will be moist and obturated using the single cone technique by gutta percha using Neosealer.
  17. For group 3, the canals will be dried using suitable size of paper points, followed by obturation using single cone technique using AH plus as a sealer.
  18. Final restoration will be placed.
  19. Post-operative pain will be accessed using The Visual Analogue Scale (VAS), after 6, 24, 48, 72 hours, and 7 days. Any analgesic pills taken by the patient will be reported.

Study Type

Interventional

Enrollment (Actual)

39

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients with mandibular molars diagnosed with symptomatic irreversible pulpitis.

Exclusion Criteria:

  1. Medically compromised patients.
  2. Pregnant patients.
  3. Teeth with immature apex formation.

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: Totalfil
Procedure: Totalfil
Root canal treatment using TotalFil sealer
Experimental: NeoSealer
Procedure: NeoSealer
Root canal treatment using NeoSealer
Active Comparator: AH-Plus
Procedure: AH-Plus sealer
Root canal treatment using AH-Plus sealer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The level of post-endodontic pain
Time Frame: 6 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 10 cm with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could be)
6 hours
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 10 cm with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could be)
24 hours
The level of post-endodontic pain
Time Frame: 48 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 10 cm with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could be)
48 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 10 cm with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could be)
72 hours
The level of post-endodontic pain
Time Frame: 7 days
Evaluation of the pain intensity using the Visual Analogue Scale. The Visual Analogue Scale measures pain intensity. The Visual Analogue Scale consists of a 10 cm with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could be)
7 days

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)

June 26, 2023

Primary Completion (Actual)

December 6, 2024

Study Completion (Actual)

January 6, 2025

Study Registration Dates

First Submitted

December 22, 2023

First Submitted That Met QC Criteria

December 22, 2023

First Posted (Actual)

January 8, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 13, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-COD-STD-123-JUNE-2023

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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