Intra-canal nano-ketorolac to reduce pain after root canal treatment
The Effect of Intra-Canal Ketorolac Application on Post-Endodontic Pain: A Randomized Controlled Clinical Trial
This trial will try placing nano-ketorolac gel inside the root canal to see if it reduces pain after root canal treatment for adults with necrotic pulp and chronic apical periodontitis.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Al-Azhar University Academic / other |
| Locations | 1 site (Giza) |
| Trial ID | NCT07064083 on ClinicalTrials.gov |
What this trial studies
This randomized, double-blind, placebo-controlled early-phase trial compares intracanal nano-ketorolac, ketorolac gel, and a placebo gel applied during root canal treatment of single-rooted teeth with necrotic pulp and chronic apical periodontitis. Standard local anesthesia, rubber dam isolation, access preparation, and canal disinfection are performed before the study medication is placed, and both patients and clinicians are blinded to allocation. Postoperative pain will be recorded at prespecified intervals using validated pain scales and compared between groups to determine short-term analgesic effect. The trial is conducted at the College of Oral and Dental Surgery, Misr University for Science and Technology in Giza.
Who should consider this trial
Good fit: Adults aged 18–50 with a single-rooted tooth diagnosed with necrotic pulp and chronic apical periodontitis who can provide informed consent and have no systemic conditions affecting pain or healing are ideal candidates.
Not a fit: Patients with irreversible pulpitis or acute periapical abscess, multi-rooted teeth, pregnancy or lactation, recent NSAID/opioid use, or those requiring multi-visit root canal therapy are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, intracanal nano-ketorolac could reduce pain after root canal treatment and decrease the need for systemic pain medicines.
How similar studies have performed: Prior research on intracanal NSAIDs is limited and shows mixed preliminary results, so the specific use of nano-ketorolac inside the canal is relatively novel and not yet proven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 18-50 years. * Patients who are diagnosed with necrotic pulp and chronic apical periodontitis in a single-rooted tooth. * Patients who provide written informed consent. * Patients with no systemic diseases affecting pain perception or wound healing. Exclusion Criteria: * Patients with irreversible pulpitis or acute periapical abscess * Patients with a history of NSAID or opioid use within 24 hours before treatment. * Pregnant or lactating women. * Patients who require more than two-visits root canal treatment due to anatomical or pathological factors.
Where this trial is running
Giza
- Collage of Oral and Dental Surgery, Misr University for Science and Technology — Giza, Egypt (Recruiting)
Study contacts
- Principal investigator: Eman Maged Fouad, PHD — Lecturer of Endodontics, Collage of Oral and Dental Surgery, Misr University for Science and Technology, Giza, Egypt.
- Study coordinator: Sabah Sobhy, PHD
- Email: sabamorad@yahoo.com
- Phone: 01096529143
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.