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Recruiting NCT07439614

Comparison of Root Canal Desinfection Protocols

No phase Interventional Periapical Periodontitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Desinfection device, Analytical microbiological methods.
Who it may be relevant to
Registry conditions: Periapical Periodontitis. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

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.

Interventions

  • Device Desinfection device
    Desinfection protocol with (LAI): Er,Cr:YSGG laser (2780 nm) delivered with a radial-firing tip.
  • Device Analytical microbiological methods
    Endocator: Measures ATP levels (Endoscore and RLU) to rapidly assess bacterial load in less than one minute.

Primary outcome measures

  • Reduction of bacteria in the root canal system [Time frame: 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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Advance Education in Endodontics Program — Buffalo

Identifiers

NCT: NCT07439614 · STUDY00009980

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗