Recruiting

Antimicrobial Protocols

Sponsor:

State University of New York at Buffalo

Code:

NCT07439614

Conditions

Periapical Periodontitis

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Interventions

Desinfection device

Analytical microbiological methods

Study Details

Brief summary:

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

Conditions

Periapical Periodontitis

Study ID

NCT07439614

Start date

Apr 1, 2026

Status verified date

Jun, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

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 Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Desinfection device

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

active comparator: Analytical microbiological method

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

Interventions

Desinfection device

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

Analytical microbiological methods

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

Primary outcome measure

  • 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. ]

Central Contacts and Locations

Central contacts

Stephen Lyon, DDS

(716) 829-6229smlyon@buffalo.edu

Thamyres Monteiro, MSc

(716) 829-6199thamyres@buffalo.edu

Locations

Advance Education in Endodontics Program

Recruiting

Buffalo, New York, United States, 14214

More Information

Sponsor

State University of New York at Buffalo

Last update posted

Jun 23, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by State University of New York at Buffalo on 2026-06-23.