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NCT Number: NCT05621681

This Prospective Study Has 2 Objectives: First, to Assess the Post-obturation Pain Utilizing Bioceramic Sealer and One Cone Technique. Second, to Compare the Intensity of Post-obturation Pain Following Unintentional Sealer Extrusion

Root canal treatment is essential step to eliminate pain and preserve tooth structures. However, errors could happen unintentionally such as ledge, perforation and sealer extrusion.

Pain through an endodontic treatment is one of the elements that most of the patients seek treatment to be relived.

One the current systemic review analyzed the pain after root canal treatment could be up to half the patients.

The purpose of this study is to evaluate and record the postoperative pain among patients who are undergoing root canal treatment.

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Key information

Conditions

Pain, Postoperative Endodontic Overfill Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Abdulaziz Abdulmunim

Buraidah, Al-Qassim Region, 56525, Saudi Arabia

Who can participate

Healthy volunteers accepted: Yes

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

"Inclusion Criteria":

  • Primary root canal
  • Asymptomatic tooth with or without apical radiolucency
  • Patient older than 18 and younger than 70
  • American Society of Anesthesiology (ASA) Class I or II

"Exclusion Criteria":

  • Patient with preoperative pain
  • Periodontal probing more than 5mm
  • When patency could not be achieved
  • pregnant patient.,
  • patients who could not properly follow the instructions for filling the visual analog card (VAS) were excluded.
  • Previously treated or initiated

Treatment and study plan

Primary outcomes

  1. Each patient was given visual assessment scale to analyze the postoperative pain and assessing the change in different time intervals (6 hours,24 hours,2 days,3days and 4 days)

    Time frame: Five times intervals were recorded at the following: 6 hours following the treatment,1 day,2days,3days and 4 days

    Visual analogue card scales contains numbers range from 0-10 1-3 indicates mild pain, while 4-6 suggests moderate pain and 7-10 specify sever pain.

Sponsors and collaborators

Lead sponsor

Abdulaziz Abdulmunim Alabdulmunim

Other

Registry information

Official study title

Postoperative Pain Assessment Following Unintentional Bioceramic Sealer Extrusion

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Nov 18, 2022
Registry last updated
Apr 3, 2024

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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