Periapical PeriodontitisNCT07439614
Comparison of Root Canal Desinfection Protocols
A study testing Desinfection device and Analytical microbiological methods in people with Periapical Periodontitis, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
Evaluate and compare the disinfecting efficacy of two supplementary antimicrobial protocols in teeth with apical periodontitis Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Periapical Periodontitis
- What is being tested?
- Desinfection device and Analytical microbiological methods
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- Patients who have received systemic antibiotics in the last 3 months
- Patients with a history of diabetes or immune impairment
- Pregnant patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Advance Education in Endodontics Program
Buffalo, New York, 14214
About this study
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
Evaluate and compare the disinfecting efficacy of two supplementary antimicrobial protocols in teeth with apical periodontitis
Read the 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.
- Conditions
- Periapical Periodontitis
- Being tested
- Desinfection device, Analytical microbiological methods
- Medical subject headings
- Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Desinfection deviceDevice
Desinfection protocol with (LAI): Er,Cr:YSGG laser (2780 nm) delivered with a radial-firing tip.
Analytical microbiological methodsDevice
Endocator: Measures ATP levels (Endoscore and RLU) to rapidly assess bacterial load in less than one minute.
| Study group | Role | What they receive |
|---|---|---|
| Desinfection device | Active comparator | Ultrasonic Activation: Piezoelectric ultrasonic unit (Dentsply International) with an Irrisafe tip (Satelec/Acteon). Receives: Device: Desinfection device |
| Analytical microbiological method | Active comparator | qPCR assay: Quantifies total bacterial DNA using 16S rRNA gene amplification. Receives: Device: Analytical microbiological methods |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Apr 2026
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periapical PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen M. Lyon, D.D.S, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07439614
- Sponsor's protocol ID
- STUDY00009980
- Status last verified
- Jun 2026
- First submitted
- 17 Feb 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07439614
- Acronym / sponsor ID
- STUDY00009980
- Conditions
- Periapical Periodontitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Desinfection device | Active comparator | Device: Desinfection deviceUltrasonic Activation: Piezoelectric ultrasonic unit (Dentsply International) with an Irrisafe tip (Satelec/Acteon). |
| Analytical microbiological method | Active comparator | Device: Analytical microbiological methodsqPCR assay: Quantifies total bacterial DNA using 16S rRNA gene amplification. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- Immature teeth
- Teeth with calcified or obliterated canals
- Teeth with extensive coronal destruction
- Teeth with previous endodontic treatment
- Symptomatic apical periodontitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Desinfection deviceDesinfection protocol with (LAI): Er,Cr:YSGG laser (2780 nm) delivered with a radial-firing tip. | Device | Desinfection device |
| Analytical microbiological methodsEndocator: Measures ATP levels (Endoscore and RLU) to rapidly assess bacterial load in less than one minute. | Device | Analytical microbiological method |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: No. 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.
Related trials for Periapical Periodontitis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Desinfection device and Analytical microbiological methods in people with Periapical Periodontitis, run by State University of New York at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephen Lyon, DDS ((716) 829-6229, smlyon@buffalo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.