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Comparison of Root Canal Desinfection Protocols

NCT07439614 — Not applicable, Recruiting, 50 participants, State University of New York at Buffalo

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Comparison of Different Root Canal Disinfection Protocols for Bacterial Reduction in Teeth With Apical Periodontitis Using Two Analytical Microbiological Methods: a Randomized Clinical Study

RegistryNCT07439614
StatusRecruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment50 (Estimated)
SponsorState University of New York at Buffalo (Other)
ConditionsPeriapical Periodontitis
InterventionsDesinfection device, Analytical microbiological methods (Device)
Datesstart 2026-04-01, primary completion 2026-12-01 (estimated), completion 2027-06-01 (estimated), first posted 2026-02-27, last updated 2026-06-23
Locations1 site in United States

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-Summary

Evaluate and compare the disinfecting efficacy of two supplementary antimicrobial protocols in teeth with apical periodontitis

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+Detailed description

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.

+Arms and interventions

ArmTypeInterventionsDescription
Desinfection deviceActive comparatorDevice: Desinfection deviceUltrasonic Activation: Piezoelectric ultrasonic unit (Dentsply International) with an Irrisafe tip (Satelec/Acteon).
Analytical microbiological methodActive comparatorDevice: Analytical microbiological methodsqPCR assay: Quantifies total bacterial DNA using 16S rRNA gene amplification.
  • Desinfection device (Device): Desinfection protocol with (LAI): Er,Cr:YSGG laser (2780 nm) delivered with a radial-firing tip.
  • Analytical microbiological methods (Device): Endocator: Measures ATP levels (Endoscore and RLU) to rapidly assess bacterial load in less than one minute.

+Outcome measures

Primary outcomes

  • Reduction of bacteria in the root canal system [Immediately after the irrigation activation procedure, ATP levels will be measured, and qPCR analysis will be performed at the end of the study, once all samples have been collected.]: Evaluation of the effectiveness of different irrigation activation devices by assessing bacterial reduction in the root canal system. ATP levels will be measured (Endoscore and RLU values) to provide a rapid assessment of bacterial load in less than one minute. Subsequently, bacterial reduction will be confirmed by quantitative polymerase chain reaction (qPCR) analysis

+Eligibility

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

+Locations (1)

FacilityCityCountryStatus
Advance Education in Endodontics ProgramBuffalo, New YorkUnited StatesRecruiting

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