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

NCT06194773 | Completed

• 1 other identifier: IRB-COD-STD-123-JUNE-2023
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Irreversible Pulpitis

Outcome Measures

Primary Outcomes (5)

• The level of post-endodontic pain

  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

  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

  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

  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

  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

Study Arms (3)

Totalfil

EXPERIMENTAL

Procedure: Totalfil

NeoSealer

EXPERIMENTAL

Procedure: NeoSealer

AH-Plus

ACTIVE COMPARATOR

Procedure: AH-Plus sealer

Interventions

Totalfil PROCEDURE

Root canal treatment using TotalFil sealer

Totalfil

NeoSealer PROCEDURE

Root canal treatment using NeoSealer

NeoSealer

AH-Plus sealer PROCEDURE

Root canal treatment using AH-Plus sealer

AH-Plus

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with mandibular molars diagnosed with symptomatic irreversible pulpitis.

You may not qualify if:

• Medically compromised patients.
• Pregnant patients.
• Teeth with immature apex formation.

Sponsors & Collaborators

• Gulf Medical University: lead

Study Sites (1)

Gulf Medical University

Ajman, 4184, United Arab Emirates

Location

MeSH Terms

Interventions

epoxy resin-based root canal sealer

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher at Thumbay Research Institute Coordinator

Study Record Dates

• First Submitted: December 22, 2023
• First Posted: January 8, 2024
• Study Start: June 26, 2023
• Primary Completion: December 6, 2024
• Study Completion: January 6, 2025
• Last Updated: March 18, 2025

Record last verified: 2025-03

Locations

AE (1)