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NCT Number: NCT07439614

Comparison of Root Canal Desinfection Protocols

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

Recruiting

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Advance Education in Endodontics Program

Buffalo, New York, 14214, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Stephen Lyon, DDS

CONTACT

[email protected]

(716) 829-6229

Thamyres Monteiro, MSc

CONTACT

[email protected]

(716) 829-6199

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Feb 27, 2026
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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