Comparison of Root Canal Desinfection Protocols

February 23, 2026 updated by: Stephen M. Lyon, D.D.S, State University of New York at Buffalo

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Desinfection device
Ultrasonic Activation: Piezoelectric ultrasonic unit (Dentsply International) with an Irrisafe tip (Satelec/Acteon).
Device: Desinfection device
Desinfection protocol with (LAI): Er,Cr:YSGG laser (2780 nm) delivered with a radial-firing tip.
Active Comparator: Analytical microbiological method
qPCR assay: Quantifies total bacterial DNA using 16S rRNA gene amplification.
Device: Analytical microbiological methods
Endocator: Measures ATP levels (Endoscore and RLU) to rapidly assess bacterial load in less than one minute.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

State University of New York at Buffalo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

February 17, 2026

First Submitted That Met QC Criteria

February 23, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 23, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00009980

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No individual participant data will be shared. All data collected will be used exclusively for this study and will be presented only in aggregated and de-identified form, in accordance with the approved protocol and informed consent.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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