Postoperative Pain After Single-Cone Root Canal Obturation Using Three Sealers

NCT07434141 | Active Not Recruiting DMC

• 1 other identifier: IR.TUMS.DENTISTRY.REC.1404.021
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare post-treatment pain after root canal therapy in adults with irreversible pulpitis using different root canal sealers. The study will also evaluate the need for pain medication after treatment. The main questions this study aims to answer are: Does the type of root canal sealer affect the intensity of pain after treatment? Does the type of sealer influence the number of analgesic tablets taken by participants? How does pain change over time after treatment with different sealers? Researchers will compare two bioceramic sealers (EndoSeal TCS and NeoSeal) with a resin-based sealer (AH Plus) to determine their effects on post-endodontic pain. Participants will: Receive root canal treatment using one of the study sealers Report their pain intensity at specific time points after treatment Record the number of analgesic tablets taken during the follow-up period

Conditions

Symptomatic Irreversible Pulpitis (SIP); Symptomatic Irreversible Pulpitis With Apical Peridontitis

Keywords

Post endodontic pain; Symptomatic irreversible pulpitis; Single cone obturation

Outcome Measures

Primary Outcomes (1)

• Post-Endodontic Pain Intensity

  Pain intensity experienced by participants after root canal treatment will be measured using a Visual Analog Scale (VAS; 0-10 numeric rating scale), where: 0 = no pain 10 = worst imaginable pain Higher scores indicate greater pain intensity (worse outcome). Participants will also record the number of analgesic tablets consumed during the first 48 hours after treatment. The maximum VAS pain score recorded during the first 48 hours will be considered the primary outcome

  Pain will be assessed at 6, 12,18, 24, and 48 hours post-treatment

Secondary Outcomes (1)

• Analgesic Consumption

  Within 48 hours post-treatment

Study Arms (3)

EndoSeal TCS

EXPERIMENTAL

Participants receive single-visit root canal treatment using the bioceramic sealer EndoSeal TCS with the single-cone obturation technique. Postoperative pain intensity and analgesic consumption are recorded at predefined time intervals

Procedure: Endoseal TCS

NeoSealer

EXPERIMENTAL

Participants receive single-visit root canal treatment using the bioceramic sealer NeoSealer with the single-cone obturation technique. Postoperative pain intensity and analgesic consumption are recorded at predefined time intervals.

Procedure: Neosealer

AH Plus

EXPERIMENTAL

Participants receive single-visit root canal treatment using the resin-based sealer AH Plus with the single-cone obturation technique. Postoperative pain intensity and analgesic consumption are recorded at predefined time intervals

Procedure: AH Plus

Interventions

Endoseal TCS PROCEDURE

Bioceramic, premixed calcium silicate-based root canal sealer used for obturation with the single-cone technique during root canal treatment

EndoSeal TCS

Neosealer PROCEDURE

Fast-setting calcium silicate-based bioceramic root canal sealer used for obturation with the single-cone technique during root canal treatment

NeoSealer

AH Plus PROCEDURE

Epoxy resin-based root canal sealer used for obturation with the single-cone technique during root canal treatment

AH Plus

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18 and 60 years
• Adequate oral and dental hygiene
• Prolonged positive response to cold test and electric pulp testing
• Clinical diagnosis of symptomatic irreversible pulpitis and symptomatic apical periodontitis in a first or second molar (maxillary or mandibular)
• Pulp exposure during caries removal accompanied by severe and profuse hemorrhage
• No radiographic evidence of periapical lesions
• Teeth with adequate restorative potential
• Absence of periodontal disease

You may not qualify if:

• Teeth that are non-restorable
• Presence of endodontic-periodontal (endo-perio) lesions
• Teeth with radiographic evidence of periapical lesions
• Teeth with internal or external root resorption
• Patients with systemic diseases classified as ASA II or higher
• Patients with a history of migraine
• Teeth with over-obturation or under-obturation greater than 2 mm from the radiographic apex
• Patients taking anti-anxiety medications
• Procedural duration exceeding two hours
• Known allergy to materials used in root canal treatment, including local anesthetics

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Study Sites (1)

Tehran University of Medical Sciences, School of Dentistry

Tehran, 1439955991, Iran

Location

MeSH Terms

Interventions

epoxy resin-based root canal sealer

Study Officials

• Shole Ghabraei, Professor

  Tehran university of medical science, school of dentistry

  PRINCIPAL INVESTIGATOR

• Hadi Assadian, Assistant Professor

  Tehran university of medical science, school of dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2026
• First Posted: February 25, 2026
• Study Start: June 8, 2025
• Primary Completion: April 1, 2026
• Study Completion: May 30, 2026
• Last Updated: February 25, 2026

Record last verified: 2026-01

Locations

IR (1)