Symptomatic Irreversible PulpitisNCT05289791
Effect of Ultrasonic Activation of Bioceramic Sealer on Postoperative Pain in Lower Premolars
A study testing ultrasonic activation of bioceramic sealer in people with Symptomatic Irreversible Pulpitis, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study is to clinically compare post-operative pain levels after ultrasonic activation of Ceraseal bioceramic sealer versus non-activated bioceramic sealer for patients with symptomatic irreversible pulpitis related to mandibular premolar teeth. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Symptomatic Irreversible Pulpitis
- What is being tested?
- ultrasonic activation of bioceramic sealer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Apr 2022to 2 May 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 above 18 years old and to 50.
- Male or female.
- Patients seeking root canal treatment.
- Mandibular posterior teeth with Symptomatic irreversible pulpitis with preoperative sharp, moderate, or severe pain with normal periapical radiographic appearance or slight widening in lamina dura.
- Systematically healthy patient (ASA I, II).
- Patient who can understand modified VAS and sign informed consent
Who cannot join
- Medically compromised patients having significant systemic disorders. (ASA III or IV).
- History of intolerance to NSAIDS.
- Patients with two or more adjacent teeth requiring endodontic treatment.
- External root resorption.
- Internal root resorption.
- Vertical root fracture.
Show all 19Show fewer
- Periapical lesion.
- Association with swelling.
- Acute peri-apical abscess or acute exacerbation of a chronic abscess.
- Pregnancy.
- Use of ibuprofen in the last 12 hour.
- Bleeding disorder.
- Long term corticosteroid use.
- Mobility Grade II or III.
- Pocket depth more than 5mm.
- Previous root canal therapy.
- Non-restorability.
- TMJ problems, bruxism, clenching or traumatic occlusion.
- Inability to perceive the given instructions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Ultrasonic Activation of Bioceramic Sealer on Postoperative Pain in Teeth With Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial
The aim of this study is to clinically compare post-operative pain levels after ultrasonic activation of Ceraseal bioceramic sealer versus non-activated bioceramic sealer for patients with symptomatic irreversible pulpitis related to mandibular premolar teeth.
Read the detailed description
To clinically compare post-operative pain levels after ultrasonic activation of Ceraseal bioceramic sealer versus non-activated bioceramic sealer for patients with symptomatic irreversible pulpitis related to mandibular premolar teeth.Ultrasonic activation of Ceraseal bioceramic sealer for 20 seconds using non cutting ultrasonic tip.
- Conditions
- Symptomatic Irreversible Pulpitis
- Being tested
- ultrasonic activation of bioceramic sealer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasonic activation of bioceramic sealerOther
activation of bioceramic sealer using ultrasonic tip for 20 seconds in buccolingual and mesiodistal direction
| Study group | Role | What they receive |
|---|---|---|
| ultrasonic activation of bioceramic sealer | Experimental | ultrasonic activation of bioceramic sealer for 20 seconds Receives: Other: ultrasonic activation of bioceramic sealer |
| bioceramic sealer | Active comparator | bioceramic sealer Receives: Other: ultrasonic activation of bioceramic sealer |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain
intensity of pain on modified Visual analogue scale
Measured: 6 hours
postoperative pain
intensity of pain on modified Visual analogue scale
Measured: 12 hours
postoperative pain
intensity of pain on modified Visual analogue scale
Measured: 24 hours
postoperative pain
intensity of pain on modified Visual analogue scale
Measured: 48 hours
Secondary outcomes (2)
number of analgesic tablets taken by patient after endodontic treatment
number of analgesics taken by patient in 1st 48 hours
Measured: up to 48 hours postoperatively
Sealer Extrusion laterally and periapically
presence or absence of sealer extrusion
Measured: Immediately after obturation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start8 Apr 2022
- Primary completion12 Apr 2023
- Study completion2 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic Irreversible PulpitisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bassant Yasser Shaker Ibrahim El-Saharty, Cairo University
- Investigators
- Heba M. El-far, professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05289791
- Sponsor's protocol ID
- ENDO 3-3-5
- Status last verified
- Nov 2023
- First submitted
- 9 Mar 2022
- Last updated
- 8 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ultrasonic Activation of Bioceramic Sealer on Postoperative Pain in Teeth With Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05289791
- Acronym / sponsor ID
- ENDO 3-3-5
- Conditions
- Symptomatic Irreversible Pulpitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 8 Apr 2022 (actual)
- Primary completion
- 12 Apr 2023 (actual)
- Study completion
- 2 May 2023 (actual)
- First posted
- 21 Mar 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.
The aim of this study is to clinically compare post-operative pain levels after ultrasonic activation of Ceraseal bioceramic sealer versus non-activated bioceramic sealer for patients with symptomatic irreversible pulpitis related to mandibular premolar teeth.
Detailed description
To clinically compare post-operative pain levels after ultrasonic activation of Ceraseal bioceramic sealer versus non-activated bioceramic sealer for patients with symptomatic irreversible pulpitis related to mandibular premolar teeth.Ultrasonic activation of Ceraseal bioceramic sealer for 20 seconds using non cutting ultrasonic tip.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ultrasonic activation of bioceramic sealer | Experimental | Other: ultrasonic activation of bioceramic sealerultrasonic activation of bioceramic sealer for 20 seconds |
| bioceramic sealer | Active comparator | Other: ultrasonic activation of bioceramic sealerbioceramic sealer |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients above 18 years old and to 50.
- Male or female.
- Patients seeking root canal treatment.
- Mandibular posterior teeth with Symptomatic irreversible pulpitis with preoperative sharp, moderate, or severe pain with normal periapical radiographic appearance or slight widening in lamina dura.
- Systematically healthy patient (ASA I, II).
Key exclusion criteria (19 listed)
- Medically compromised patients having significant systemic disorders. (ASA III or IV).
- History of intolerance to NSAIDS.
- Patients with two or more adjacent teeth requiring endodontic treatment.
- External root resorption.
- Internal root resorption.
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 |
|---|---|---|
| ultrasonic activation of bioceramic sealeractivation of bioceramic sealer using ultrasonic tip for 20 seconds in buccolingual and mesiodistal direction | Other | bioceramic sealer, ultrasonic activation of bioceramic sealer |
Primary outcome
postoperative pain
Time frame: 6 hours
intensity of pain on modified Visual analogue scale
postoperative pain
Time frame: 12 hours
intensity of pain on modified Visual analogue scale
postoperative pain
Time frame: 24 hours
intensity of pain on modified Visual analogue scale
postoperative pain
Time frame: 48 hours
intensity of pain on modified Visual analogue scale
2 secondary outcomes
number of analgesic tablets taken by patient after endodontic treatment
Time frame: up to 48 hours postoperatively
Sealer Extrusion laterally and periapically
Time frame: Immediately after obturation.
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 8 Nov 2023.
Related trials for Symptomatic Irreversible Pulpitis
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Not yet recruitingPhase 3
Submucosal Cryotherapy and Anti-inflammatory Drugs for Postoperative Pain Following Root Canal Treatment in Maxillary Molars
Pulpitis
Recruiting
Intraligamentary vs Inferior Alveolar Nerve Block for Pulpitis: A Randomized Clinical Trial
Symptomatic Irreversible Pulpitis (SIP), Dental Pain
Not yet recruitingPhase 4
Cost-Effectiveness of Upfront Supplemental Anaesthesia in Symptomatic Irreversible Pulpitis
Irreversible Pulpitis, Anesthesia, Local
Recruiting
Effect of Menstrual Phase on the Anesthetic Efficacy
Pulpitis - Irreversible
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.
Heba M. El-far, professor study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasonic activation of bioceramic sealer in people with Symptomatic Irreversible Pulpitis, run by Cairo University 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 6 inclusion and 19 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: finished, as of the sponsor's last update on 8 Nov 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?
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?
postoperative pain (time frame: 6 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 8 Nov 2023.