Comparing two methods of activating a bio-ceramic sealer for pain relief in root canal treatments
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
This study is testing two different ways to activate a special dental sealer to see which one helps reduce pain better for people getting root canal treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | Future University in Egypt Academic / other |
| Locations | 1 site (Cairo, New Cairo) |
| Trial ID | NCT06640218 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of two different activation methods, Eddy Sonic and AF Max, for a bio-ceramic sealer in reducing postoperative pain in patients undergoing root canal treatment for irreversible pulpitis with apical periodontitis. A total of 30 patients will be recruited and divided into three groups, with one group receiving no activation as a control. The study aims to determine which method provides better pain relief after the procedure. Participants will be selected based on specific inclusion criteria, ensuring they have the appropriate dental condition and are systematically healthy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 40 with symptomatic irreversible pulpitis in mandibular first molars who are seeking root canal treatment.
Not a fit: Patients with ASA classifications other than ASA I and II or those who have taken preoperative analgesics within 12 hours may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for patients undergoing root canal treatments.
How similar studies have performed: While there is limited information on the specific methods being tested, similar studies in endodontics have shown varying degrees of success in pain management techniques.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. * 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. Exclusion Criteria: * 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. * 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.
Where this trial is running
Cairo, New Cairo
- Future University in Egypt — Cairo, New Cairo, Egypt (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.