Evaluating the impact of three medications on pain management during dental procedures
The Effect of Premedication With Trypsin, Bromelain and Rutoside Combination on the Success of IAN Block and Post Endodontic Pain in Patients With Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial
This study is testing whether three new anti-inflammatory medications can help people with painful tooth issues feel less pain during and after dental procedures compared to traditional pain relief options.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cairo University Academic / other |
| Locations | 2 sites (Badr city, Cairo and 1 other locations) |
| Trial ID | NCT06298383 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of three different medications in improving anesthetic success and reducing postoperative pain in patients with symptomatic irreversible pulpitis. The study focuses on the use of a new category of anti-inflammatory medications, including Trypsin, Bromelain, and Rutoside, compared to traditional options like Diclofenac Potassium and Prednisolone. By addressing the challenges of achieving adequate anesthesia in inflamed tissues, the trial aims to enhance pain management during root canal treatments. Participants will be monitored for pain levels and anesthetic efficacy throughout the procedure.
Who should consider this trial
Good fit: Ideal candidates include individuals with symptomatic irreversible pulpitis experiencing moderate-to-severe pain in mandibular molars.
Not a fit: Patients with allergies to the study medications, pregnant or lactating women, or those with certain medical histories 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: Previous studies have explored pain management in dental procedures, but this specific combination of medications is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with symptomatic irreversible pulpitis. * Patients with active pain (moderate-to-severe) in mandibular molars. * Males and females. * Patient with the ability to understand and use pain scales. * Patient who accepts to enroll to the study Exclusion Criteria: * Patients' allergies or any other contraindication to any of the used medications or mepivacaine. * Pregnant and lactating females. * Patients have been taking pain medication 12 hours earlier. * Patient has more than one symptomatic mandibular tooth in the same quadrant. * Patients with periradicular pathosis and/or radiolucency other than widened periodontal ligaments. * Patients with contributory medical history (ASA\>II).
Where this trial is running
Badr city, Cairo and 1 other locations
- Faculty of Oral and Dental Medicine, Egyptian Russian University — Badr city, Cairo, Egypt (Recruiting)
- Faculty of Dentistry, Cairo University — Cairo, Egypt (Recruiting)
Study contacts
- Principal investigator: Maha Nasr — Egyptian Russian University
- Study coordinator: Maha Nasr
- Email: maha-nasrmorsi@eru.edu.eg
- Phone: 01114367063
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.