Nano-sized intracanal medications to reduce periapical inflammation after root canal retreatment
Modulation of Periapical Inflammation Following Nano-Calcium Hydroxide and Nano-Chitosan Intracanal Medications in Endodontic Retreatment Cases: A Randomized Controlled Clinical Trial
This trial tests whether nano-calcium hydroxide or nano-chitosan pastes can reduce periapical inflammation and post-operative pain in adults undergoing endodontic retreatment of single-rooted teeth.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 63 (estimated) |
| Ages | 20 Years to 40 Years |
| Sex | Male |
| Sponsor | Al-Azhar University Academic / other |
| Locations | 1 site (Cairo, Nasr City) |
| Trial ID | NCT07571837 on ClinicalTrials.gov |
What this trial studies
Sixty-three patients with previously treated single-rooted teeth and periapical radiolucency will be randomized into three equal groups to receive either nano-chitosan paste, nano-calcium hydroxide paste, or standard calcium hydroxide as intracanal medicament. Retreatment procedures include gutta-percha removal, standardized rotary instrumentation, irrigation, and microbiologic sampling before medicament placement. Group assignment is concealed using sequentially numbered opaque envelopes and simple randomization. Outcomes focus on periapical inflammation and post-operative pain following the intervention.
Who should consider this trial
Good fit: Adults with a single-rooted tooth that has failed prior endodontic therapy, a periapical radiolucency (PAI score 3 or 4), and no current pain or swelling are ideal candidates.
Not a fit: Patients with systemic disease, recent antibiotic use, pregnancy or lactation, non-restorable or fractured teeth, immature roots, resorption, sinus tract, or multi-rooted cases are unlikely to benefit from enrolling.
Why it matters
Potential benefit: If successful, these nano-formulations could reduce inflammation and pain after retreatment and promote better periapical healing compared with standard calcium hydroxide.
How similar studies have performed: Laboratory and some animal studies suggest nano-calcium hydroxide and chitosan have improved antimicrobial and anti-inflammatory properties, but clinical evidence in humans remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Patients have single rooted teeth with root canal form type I. Have previous endodontic therapy with failure. Have periapical radiolucency (PAI score of 3 or 4). Asymptomatic patients who had no pain or swelling, had a negative response to palpation and percussion. Exclusion Criteria: Patients who had received antibiotic therapy within the past 3 months. Pregnancy and lactation. Systemic disease. Physical or mental disability. Non-restorable teeth. Any signs of resorption, immature roots, fracture, sinus tract and dental anomaly
Where this trial is running
Cairo, Nasr City
- Al Azhar University — Cairo, Nasr City, Egypt (Recruiting)
Study contacts
- Study coordinator: Sabah Morad Sobhy, PHD
- Email: sabamorad@yahoo.com
- Phone: +201096529143
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.