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

Pain, Postoperative Clinical Trial

Official title:

Postoperative Pain Assessment Following Unintentional Bioceramic Sealer Extrusion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05621681
• Other study ID #: Abdulaziz Abdulmunim
• Status: Completed
• Start date: January 15, 2023
• Est. completion date: July 15, 2023

Study information

• Verified date: April 2024
• Source: Qassim University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: July 15, 2023
• Est. primary completion date: June 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

"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

Related Conditions & MeSH terms

• Pain, Postoperative

Locations

Country	Name	City	State
Saudi Arabia	Abdulaziz Abdulmunim	Buraidah	Qassim

Sponsors (1)

Lead Sponsor	Collaborator
Abdulaziz Abdulmunim Alabdulmunim

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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