Post Operative PainNCT05729893
Evaluation of Post Operative Pain After Using Two Different Types of Sealers
A study testing root canal sealers in people with Post Operative Pain, run by British University In Egypt at 1 site in Egypt.
Trial summary
conventional endodontic treatment is done using two different types of sealers in the obturation to evaluate the post operative pain between the two sealers Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- root canal sealers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2023to 1 Sep 2023
- Phase
- Interventional
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • Patients age ranges from 18-50 years old.
- Patients with teeth diagnosed with symptomatic irreversible pulpitis.
- Normal periapical condition confirmed by normal periapical radiograph or that with minimal widening of the PDL space
- The teeth are restorable
- Teeth are periodontally free.
Who cannot join
- • Teeth with immature roots
- Non restorable teeth
- Medically compromised patients with systemic complication that would alter the treatment.
- Necrotic teeth
- Teeth with apical periodontitis or periapical lesions
- Teeth that need multiple visits treatment
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
British university in egypt
Cairo, 02
sara tarek mohamed, bachelor, 01007434392, sara.alsayed@bue.edu.eg
hala fayek khalil, lecturer, 01287595795, hala.fayek@bue.edu.eg
About this study
Official title: Evaluation of Post Operative Pain After Using Two Different Types of Sealers (a Randomized Clinical Trial )
conventional endodontic treatment is done using two different types of sealers in the obturation to evaluate the post operative pain between the two sealers
Read the detailed description
STUDY WILL BE PERFORMED ON PATIENTS DIAGNOSED WITH SYMPTOMATIC IRREVERSABE PULPITIS.
TREATMENT PROTOCOL FOR ALL PATIENTS IS CONVENTIONAL ROOT CANAL TREATMENT
ACCESS CAVITY AND CLEANING AND SHAPING PROCEDURES WILL BE EXECUTED FOR ALL PATIENTS WITH THE SAME PROTOCOL
SELECTED PATIENTS WILL THEN BE DIVIDED INTO TWO GROUPS,
GROUP1: ALL CANALS WILL BE OBTURATED USING RESIN STANDARD SEALERS.
GROUP2: ALL CANALS WILL BE OBTURATED USING HIGH FLOW BIOCERAMIC SEALERS THAT ACCEPT WARM VERTICAL COMPACTION
POST OPERATIVE PAIN IN THE TWO GROUPS WILL BE EVALUATED USING THE VISUAL ANALOUG SCALE AND COMPARED AT DIFFERENT TIME PERIODS (12H, 24H, 48H, 72H)
- Conditions
- Post Operative Pain
- Being tested
- root canal sealers
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
root canal sealersOther
Also called bioceramic sealer
different sealer used in obturating root canals (resin and bio ceramic)
| Study group | Role | What they receive |
|---|---|---|
| resin group | Active comparator | obturated with resin sealer Receives: Other: root canal sealers |
| bio ceramic group | Active comparator | obturated with bioceramic sealer Receives: Other: root canal sealers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level comparison after root canal obturation with two different endodontic sealers: VAS (Visual Analogue Scale) at 12 hours
Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.
Measured: 12 hours
Pain level comparison after root canal obturation with two different endodontic sealers: VAS (Visual Analogue Scale) at 24 hours
Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.
Measured: 24 hours
Pain level comparison after root canal obturation with two different endodontic sealers: VAS (Visual Analogue Scale) at 48 hours
Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.
Measured: 48 hours
Pain level comparison after root canal obturation with two different endodontic sealers: VAS (Visual Analogue Scale) at 72 hours
Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start1 Feb 2023
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- British University In Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Alsayed Endo, British University In Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05729893
- Sponsor's protocol ID
- BritishUE sara
- Status last verified
- Feb 2023
- First submitted
- 5 Jan 2023
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: evaluated postoperative pain results when using different sealer types in obturation
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Post Operative Pain After Using Two Different Types of Sealers (a Randomized Clinical Trial )
- ClinicalTrials.gov ID
- NCT05729893
- Acronym / sponsor ID
- BritishUE sara
- Conditions
- Post Operative Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- British University In EgyptUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 15 Feb 2023 (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.
conventional endodontic treatment is done using two different types of sealers in the obturation to evaluate the post operative pain between the two sealers
Detailed description
STUDY WILL BE PERFORMED ON PATIENTS DIAGNOSED WITH SYMPTOMATIC IRREVERSABE PULPITIS.
TREATMENT PROTOCOL FOR ALL PATIENTS IS CONVENTIONAL ROOT CANAL TREATMENT
ACCESS CAVITY AND CLEANING AND SHAPING PROCEDURES WILL BE EXECUTED FOR ALL PATIENTS WITH THE SAME PROTOCOL
SELECTED PATIENTS WILL THEN BE DIVIDED INTO TWO GROUPS,
GROUP1: ALL CANALS WILL BE OBTURATED USING RESIN STANDARD SEALERS.
GROUP2: ALL CANALS WILL BE OBTURATED USING HIGH FLOW BIOCERAMIC SEALERS THAT ACCEPT WARM VERTICAL COMPACTION
POST OPERATIVE PAIN IN THE TWO GROUPS WILL BE EVALUATED USING THE VISUAL ANALOUG SCALE AND COMPARED AT DIFFERENT TIME PERIODS (12H, 24H, 48H, 72H)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| resin group | Active comparator | Other: root canal sealersobturated with resin sealer |
| bio ceramic group | Active comparator | Other: root canal sealersobturated with bioceramic sealer |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- • Patients age ranges from 18-50 years old.
Key exclusion criteria (6 listed)
- • Teeth with immature roots
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| root canal sealersAlso: bioceramic sealerdifferent sealer used in obturating root canals (resin and bio ceramic) | Other | bio ceramic group, resin group |
Primary outcome
Pain level comparison after root canal obturation with two different endodontic sealers: VAS (Visual Analogue Scale) at 12 hours
Time frame: 12 hours
Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.
Pain level comparison after root canal obturation with two different endodontic sealers: VAS (Visual Analogue Scale) at 24 hours
Time frame: 24 hours
Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.
Pain level comparison after root canal obturation with two different endodontic sealers: VAS (Visual Analogue Scale) at 48 hours
Time frame: 48 hours
Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.
Pain level comparison after root canal obturation with two different endodontic sealers: VAS (Visual Analogue Scale) at 72 hours
Time frame: 72 hours
Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- Individual participant dataSharing planned: No. evaluated postoperative pain results when using different sealer types in obturation
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing root canal sealers in people with Post Operative Pain, run by British University In Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 15 Feb 2023. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact sara tarek mohamed, bachelor (01007434392, sara.alsayed@bue.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain level comparison after root canal obturation with two different endodontic sealers: VAS (Visual Analogue Scale) at 12 hours (time frame: 12 hours). The study lists 4 primary outcomes in all. 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 15 Feb 2023.