Comparison of Different Root Canal Disinfection Protocols for Bacterial Reduction in Teeth With Apical Periodontitis Using Two Analytical Microbiological Methods: a Randomized Clinical Study
| Registry | NCT07439614 |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 50 (Estimated) |
| Sponsor | State University of New York at Buffalo (Other) |
| Conditions | Periapical Periodontitis |
| Interventions | Desinfection device, Analytical microbiological methods (Device) |
| Dates | start 2026-04-01, primary completion 2026-12-01 (estimated), completion 2027-06-01 (estimated), first posted 2026-02-27, last updated 2026-06-23 |
| Locations | 1 site in United States |
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Evaluate and compare the disinfecting efficacy of two supplementary antimicrobial protocols in teeth with apical periodontitis
This study aims to evaluate and compare the disinfecting efficacy of two supplementary antimicrobial protocols in teeth with apical periodontitis: Er,Cr:YSGG laser activated irrigation and ultrasonic activation using a piezoelectric ultrasonic device (Dentsply International Inc., York, PA, USA) and Irrisafe tip (Satelec/Acteon, Merignac, France), comparing the detection of bacteria before and after instrumentation.
Secondary aims are to assess presence of bacteria before and after chemomechanical preparation using two microbiological methods:
* ATP level analysis using the Endocator device
* Quantitative PCR (qPCR) for total bacterial quantification.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Desinfection device | Active comparator | Device: Desinfection device | Ultrasonic Activation: Piezoelectric ultrasonic unit (Dentsply International) with an Irrisafe tip (Satelec/Acteon). |
| Analytical microbiological method | Active comparator | Device: Analytical microbiological methods | qPCR assay: Quantifies total bacterial DNA using 16S rRNA gene amplification. |
Sex: All, ages: 18 Years to 70 Years, accepts healthy volunteers
Inclusion Criteria: * Adult patients able to give informed consent and willing/able to comply with study procedures and follow-up. * Molar teeth indicated for endodontic treatment. * Teeth with intact pulp-chamber walls (no extensive coronal destruction). * Necrotic pulp confirmed by pulp testing. * Clinical and radiographic evidence of asymptomatic apical periodontitis. Exclusion Criteria: * Immature teeth * Teeth with calcified or obliterated canals * Teeth with extensive coronal destruction * Teeth with previous endodontic treatment * Symptomatic apical periodontitis * Teeth with periodontal pockets greater than 4 mm * Patients who have received systemic antibiotics in the last 3 months * Patients with a history of diabetes or immune impairment * Pregnant patients
| Facility | City | Country | Status |
|---|---|---|---|
| Advance Education in Endodontics Program | Buffalo, New York | United States | Recruiting |