Pain, PostoperativeNCT05621681
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
An observational study of Pain, Postoperative and Endodontic Overfill, run by Abdulaziz Abdulmunim Alabdulmunim at 1 site in Saudi Arabia.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, Endodontic Overfill
- How many people
- 145 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 15 Jan 2023to 15 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Primary dental care
"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
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Abdulaziz Abdulmunim
Buraidah, Al-Qassim Region, 56525
About this study
Official title: Postoperative Pain Assessment Following Unintentional Bioceramic 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.
- Conditions
- Pain, Postoperative, Endodontic Overfill
- Keywords
- Sealer extrusion, Postoperative pain
- Medical subject headings
- Pain, Postoperative
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Five times intervals were recorded at the following: 6 hours following the treatment,1 day,2days,3days and 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2022
- Study start15 Jan 2023
- Primary completion15 Jun 2023
- Study completion15 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abdulaziz Abdulmunim Alabdulmunim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Abdulaziz Abdulmunim Alabdulmunim, Qassim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05621681
- Sponsor's protocol ID
- Abdulaziz Abdulmunim
- Status last verified
- Apr 2024
- First submitted
- 5 Nov 2022
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain Assessment Following Unintentional Bioceramic Sealer Extrusion
- ClinicalTrials.gov ID
- NCT05621681
- Acronym / sponsor ID
- Abdulaziz Abdulmunim
- Conditions
- Pain, Postoperative, Endodontic Overfill
- Keywords
- Sealer extrusion, Postoperative pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Abdulaziz Abdulmunim AlabdulmunimUniversity, hospital or other
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 15 Jul 2023 (actual)
- First posted
- 18 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary dental care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Postoperative and Endodontic Overfill, run by Abdulaziz Abdulmunim Alabdulmunim at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.