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OpenTrials
Completed

NCT Number: NCT06795282

Post Operative Sensitivity of MTA Obturation

The aim of this study was to investigate the difference in postoperative pain caused by different root canal sealers in patients with irreversible pulpitis symptoms and no apical lesions.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Erciyes University Faculty of Dentistry

Kayseri, 38000, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • asymptomatic tooth with delayed positive response to thermal tests and electric pulp tests
  • large pulp perforation during caries removal,
  • inflamed pulp in which bleeding could not be controlled within 5 min,
  • periodontally healthy mature mandibular first or second molar tooth.

Exclusion criteria

  • patients if they were diabetic, immunocompromised, pregnant,
  • had a positive history of antibiotic use during the past 1 month,
  • required antibiotic prophylaxis
  • used analgesic within 7 days prior to the beginning of treatment,
  • were allergic to the materials used during root canal treatment,
  • if the bleeding could be controlled within 5 min and vital pulp treatment could be performed,
  • the tooth had negative response to vitality tests and/or was symptomatic,
  • had an associated periapical lesion visible on a radiograph,
  • needed a post-core or was planned to serve as prosthetic support,
  • had a calcified root canal and internal or external root resorption,
  • had tooth with open apex
  • mandibular third molars

Treatment and study plan

MTA

Drug

MTA is primarily composed of tricalcium silicate, dicalcium silicate, bismuth oxide (for radiopacity), and small amounts of calcium sulfate. MTA is highly biocompatible, making it suitable for use in the root canal system and areas in close contact with tissues.

Primary outcomes

  1. 7-day postoperative pain after root canal treatment

    Time frame: 7 days

    At the end of the visit, patients were educated to record their postoperative pain level by assigning a number between 0 and 10 using the numerical rating scale (NRS) chart. They were categorized into four: 0=no pain, 1-3=mild pain, 4-6=moderate pain, and 7-10=severe pain. The patients were asked to record their pain level preoperatively, at 6, 12, and 24 h, and daily for up to 7 days, and return it to he investigators at a specific time.

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Registry information

Official study title

Effects of Three Different Root Canal Filling Materials Used in Single-Session Root Canal Treatment on Postoperative Pain: A Randomized Clinical Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 28, 2025
Registry last updated
Jan 2, 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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