Comparison of Root Canal Desinfection Protocols

NCT07439614 | Not Yet Recruiting

• 1 other identifier: STUDY00009980
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Periapical Periodontitis

Outcome Measures

Primary Outcomes (1)

• Reduction of bacteria in the root canal system

  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.

Study Arms (2)

Desinfection device

ACTIVE COMPARATOR

Ultrasonic Activation: Piezoelectric ultrasonic unit (Dentsply International) with an Irrisafe tip (Satelec/Acteon).

Device: Desinfection device

Analytical microbiological method

ACTIVE COMPARATOR

qPCR assay: Quantifies total bacterial DNA using 16S rRNA gene amplification.

Device: Analytical microbiological methods

Interventions

Desinfection device DEVICE

Desinfection protocol with (LAI): Er,Cr:YSGG laser (2780 nm) delivered with a radial-firing tip.

Desinfection device

Analytical microbiological methods DEVICE

Endocator: Measures ATP levels (Endoscore and RLU) to rapidly assess bacterial load in less than one minute.

Analytical microbiological method

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• State University of New York at Buffalo: lead

MeSH Terms

Conditions

Periapical Periodontitis

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Central Study Contacts

Stephen Lyon, DDS

CONTACT

(716) 829-6229; smlyon@buffalo.edu

Thamyres Monteiro, MSc

CONTACT

(716) 829-6199; thamyres@buffalo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a parallel-group interventional study in which participants are allocated to different treatment arms according to the intervention received (laser or ultrasound), following standardized clinical protocols.

Study Record Dates

• First Submitted: February 17, 2026
• First Posted: February 27, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share