Irreversible Pulpitis With Apical PeriodontitisNCT06640218
The Effect of Eddy Sonic Versus AF Max Activation of Bio-ceramic Sealer on Post-operative Pain in Teeth With Symptomatic Irreversible Pulpitis With Apical Periodontitis
A study testing sealer activation with Eddy sonic and AF max and without AF max or Eddy sonic sealer activation in people with Irreversible Pulpitis With Apical Periodontitis, run by Future University in Egypt at 1 site in Egypt.
Trial summary
The aim of endodontic therapy for an inflamed tooth is to eliminate the source of inflammation. Relieving pain depends on the effectiveness of root canal therapy.3 Postoperative pain in endodontic treatments, affecting 3-58% of patients, is often caused by peri-radicular tissue injuries. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Irreversible Pulpitis With Apical Periodontitis
- What is being tested?
- sealer activation with Eddy sonic and AF max and without AF max or Eddy sonic sealer activation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2024to 1 Apr 2026
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age range is from 18 to 40 years old.
- No sex predilection
- Patients seeking root canal treatment.
- restorable teeth.
- Positive patient acceptance for participating in the study.
- patients able to sign informed consent.
Show all 12Show fewer
- Systematically healthy patient (ASA I, Il).
- Patient who can understand the numerical rate scale and sign an informed consent.
- Mandibular first molar teeth with pain on bite or percussion
- Preoperative sharp (moderate or severe) pain.
- Vital response of pulp tissue to cold pulp tester (ethyl chloride spray).
- widening in periodontal membrane space in radiographic appearance.
Who cannot join
- Patients with American Association of Anesthesiologists (ASA) classifications other than ASA 1 \& Il
- Patients who have already ingested preoperative medication, such as analgesics, non-steroidal, or steroidal anti-inflammatory drugs, within 12 hours of the start of treatment.
- This was done to prevent any misinterpretation of the diagnosis or post-treatment pain severity, as these drugs substantially lower post-endodontic pain (Jorge-Arajo et al.,2018).
- Patients with NSAID allergy.
- Patients having two or more adjacent teeth needing root canal therapy
- Pregnant patients.
Show all 21Show fewer
- Patients with bleeding disorder.
- Patients with long-term corticosteroid use.
- Teeth having:
- Necrotic pulp.
- History or presence of swelling or fistulous tract.
- Acute/chronic periapical abscess.
- Mobility more than grade 1.
- Pocket depth of more than 5mm
- No possible restorability.
- Previous root canal treatment.
- Periapical radiolucency.
- External or internal resorption
- Vertical root fracture.
- TMJ problems, bruxism, clenching or traumatic occlusion.
- Inability to understand and perform the given instructions.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of endodontic therapy for an inflamed tooth is to eliminate the source of inflammation. Relieving pain depends on the effectiveness of root canal therapy.3
Postoperative pain in endodontic treatments, affecting 3-58% of patients, is often caused by peri-radicular tissue injuries. Understanding these factors helps professionals select methods and supplies to minimize discomfort.
30 patients will be divided into 3 groups according to the method of activation (10 par ticipants/each). participants will be recruited from the postgrad clinic of the endodontic department faculty of oral and dental medicine, Future University in Egypt Patients with mature mandibular first permanent molar with irreversible pulpitis with apical periodontitis Intervention 1: bio-ceramic sealer activation with Eddy sonic Intervention 2: bio-ceramic sealer activation with AF max Control/Comparator: bio-ceramic sealer without activation The study aims to evaluate the effect of Eddy Sonic and AF max activation of bio-ceramic sealer on postoperative pain in mandibular first molars with symptomatic irreversible pulpitis with apical periodontitis
- Being tested
- sealer activation with Eddy sonic and AF max, without AF max or Eddy sonic sealer activation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sealer activation with Eddy sonic and AF maxDevice
activation of sealer after cleaning and shaping, before the obturation
without AF max or Eddy sonic sealer activationOther
sealer without activation
| Study group | Role | What they receive |
|---|---|---|
| bio-ceramic sealer activation with Eddy sonic before obturation | Active comparator | cleaning and shaping the root canals and Well Root bio ceramic sealer activation using Eddy sonic before obturation |
| bio-ceramic sealer activation with AF max before obturation | Active comparator | cleaning and shaping the root canals and Well Root bio ceramic sealer activation using AF max before obturation Receives: Device: sealer activation with Eddy sonic and AF max |
| bio-ceramic sealer obturation without any activation (negative control) | Active comparator | obturation of root canals with bio ceramic sealer directly without any activation |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-operative pain after root canal treatment with sealer activation by AF max and Eddy sonic activation in comparison to without sealer activation
measuring post-operative pain by Numerical rate scale and pain level will be assigned to one of 4 categorical scores: None (0); Mild (1-3); Moderate (4-6); Severe (7-10).
Measured: Immediately after obturation 6-12-24 and 48 hours post-operative
Secondary outcomes (1)
Number of analgesic tablets taken after endodontic treatment
measuring number of analgesic tablets taken after endodontic treatment by counting
Measured: Up to 48 hours post-operative pain
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Nov 2024
- Primary completion1 Nov 2025
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irreversible Pulpitis With Apical PeriodontitisStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Youssef Abd El Hameed Mohamed Ahmed, Future University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06640218
- Sponsor's protocol ID
- FUE-REC code (17)/7/2024
- Status last verified
- Jan 2026
- First submitted
- 7 Oct 2024
- Last updated
- 2 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Eddy Sonic Versus AF Max Activation of Bio-ceramic Sealer on Post-operative Pain in Teeth With Symptomatic Irreversible Pulpitis With Apical Periodontitis
- ClinicalTrials.gov ID
- NCT06640218
- Acronym / sponsor ID
- FUE-REC code (17)/7/2024
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 15 Oct 2024 (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 endodontic therapy for an inflamed tooth is to eliminate the source of inflammation. Relieving pain depends on the effectiveness of root canal therapy.3
Postoperative pain in endodontic treatments, affecting 3-58% of patients, is often caused by peri-radicular tissue injuries. Understanding these factors helps professionals select methods and supplies to minimize discomfort.
30 patients will be divided into 3 groups according to the method of activation (10 par ticipants/each). participants will be recruited from the postgrad clinic of the endodontic department faculty of oral and dental medicine, Future University in Egypt Patients with mature mandibular first permanent molar with irreversible pulpitis with apical periodontitis Intervention 1: bio-ceramic sealer activation with Eddy sonic Intervention 2: bio-ceramic sealer activation with AF max Control/Comparator: bio-ceramic sealer without activation The study aims to evaluate the effect of Eddy Sonic and AF max activation of bio-ceramic sealer on postoperative pain in mandibular first molars with symptomatic irreversible pulpitis with apical periodontitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| bio-ceramic sealer activation with Eddy sonic before obturation | Active comparator | –cleaning and shaping the root canals and Well Root bio ceramic sealer activation using Eddy sonic before obturation |
| bio-ceramic sealer activation with AF max before obturation | Active comparator | Device: sealer activation with Eddy sonic and AF maxcleaning and shaping the root canals and Well Root bio ceramic sealer activation using AF max before obturation |
| bio-ceramic sealer obturation without any activation (negative control) | Active comparator | –obturation of root canals with bio ceramic sealer directly without any activation |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Age range is from 18 to 40 years old.
- No sex predilection
- Patients seeking root canal treatment.
- restorable teeth.
- Positive patient acceptance for participating in the study.
Key exclusion criteria (21 listed)
- Patients with American Association of Anesthesiologists (ASA) classifications other than ASA 1 \& Il
- Patients who have already ingested preoperative medication, such as analgesics, non-steroidal, or steroidal anti-inflammatory drugs, within 12 hours of the start of treatment.
- This was done to prevent any misinterpretation of the diagnosis or post-treatment pain severity, as these drugs substantially lower post-endodontic pain (Jorge-Arajo et al.,2018).
- Patients with NSAID allergy.
- Patients having two or more adjacent teeth needing root canal therapy
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 |
|---|---|---|
| sealer activation with Eddy sonic and AF maxactivation of sealer after cleaning and shaping, before the obturation | Device | bio-ceramic sealer activation with AF max before obturation |
| without AF max or Eddy sonic sealer activationsealer without activation | Other | – |
Primary outcome
post-operative pain after root canal treatment with sealer activation by AF max and Eddy sonic activation in comparison to without sealer activation
Time frame: Immediately after obturation 6-12-24 and 48 hours post-operative
measuring post-operative pain by Numerical rate scale and pain level will be assigned to one of 4 categorical scores: None (0); Mild (1-3); Moderate (4-6); Severe (7-10).
1 secondary outcome
Number of analgesic tablets taken after endodontic treatment
Time frame: Up to 48 hours post-operative 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 2 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Irreversible Pulpitis With Apical Periodontitis
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
Not yet recruitingObservational study
Neurokinin A and Matrix Metalloproteinase 9 Levels in Gingival Crevicular Fluid Samples of Teeth With Symptomatic Irreversible Pulpitis With Symptomatic Apical Periodontitis
Symptomatic Irreversible Pulpitis With Apical Peridontitis
Not yet recruiting
Full Pulpotomy in Permanent Teeth With Irreversible Pulpitis and Apical Periodontitis
Irreversible Pulpitis With Apical Periodontitis
Not yet recruiting
Assessment of Post-Operative Pain After Using Cryotherapy and Dexamethasone
Post Operative Pain
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?
A study testing sealer activation with Eddy sonic and AF max and without AF max or Eddy sonic sealer activation in people with Irreversible Pulpitis With Apical Periodontitis, run by Future 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 12 inclusion and 21 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 2 Sep 2026. 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?
post-operative pain after root canal treatment with sealer activation by AF max and Eddy sonic activation in comparison to without sealer activation (time frame: Immediately after obturation 6-12-24 and 48 hours post-operative). 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 2 Sep 2026.