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NCT Number: NCT07434141

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

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tehran University of Medical Sciences, School of Dentistry

Tehran, 1439955991, Iran

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Endoseal TCS

Procedure

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

Neosealer

Procedure

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

AH Plus

Procedure

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

Primary outcomes

  1. Post-Endodontic Pain Intensity

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

    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

Secondary outcomes

  1. Analgesic Consumption

    Time frame: Within 48 hours post-treatment

    Total number of analgesic tablets consumed by participants during the first 48 hours after treatment

Sponsors and collaborators

Lead sponsor

Tehran University of Medical Sciences

Other

Registry information

Official study title

Comparative Analysis of Postoperative Pain in Symptomatic Irreversible Pulpitis Teeth Following Single Cone Obturation Using Three Different Sealers: A Randomized Clinical Trial

Acronym: POP-RCT

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 25, 2026
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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