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

NCT05621681 | Completed

• 1 other identifier: Abdulaziz Abdulmunim
• Study Type: observational
• Target: 145
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain, Postoperative; Endodontic Overfill

Keywords

Sealer extrusion; Postoperative pain

Outcome Measures

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)

  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.

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

Eligibility Criteria

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

Study Population

Primary dental care

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abdulaziz Abdulmunim Alabdulmunim: lead

Study Sites (1)

Abdulaziz Abdulmunim

Buraidah, Al-Qassim Region, 56525, Saudi Arabia

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Intern

Study Record Dates

• First Submitted: November 5, 2022
• First Posted: November 18, 2022
• Study Start: January 15, 2023
• Primary Completion: June 15, 2023
• Study Completion: July 15, 2023
• Last Updated: April 3, 2024

Record last verified: 2024-04

Locations

SA (1)