Apical PeriodontitisNCT07469150
Efficacy of Different Disinfection Technologies in Molar Non-Surgical Retreatment
A study testing GentleWave System and Conventional rotary instrumentation with passive ultrasonic irrigation in people with Apical Periodontitis, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
Post-treatment apical periodontitis is commonly associated with persistent intracanal infection following root canal treatment. Effective disinfection of the complex root canal system during nonsurgical retreatment remains challenging due to anatomical complexities that may harbor microbial biofilms. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Apical Periodontitis
- What is being tested?
- GentleWave System and Conventional rotary instrumentation with passive ultrasonic irrigation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2027to Dec 2030
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Molars showing radiographic evidence of post-treatment apical periodontitis: a lesion that exceeds 3 mm in diameter on one or more roots.
- Evidence from periapical and CBCT examination suggests that retreatment is a viable option, i.e., there are low risks of vertical root fracture, no major root canal obstruction, evidence of coronal leakage, and potential improvement on the previous treatment.
- The initial root canal therapy was performed at least 2 years previously, or more than 1 year if the patient has signs and symptoms or symptomatic disease (pain, swelling, or sinus tracts).
- Patients show no chronic systemic disease that may influence the outcome of care, such as uncontrolled diabetes, autoimmune disease, malignancy treated with chemotherapy or patients who are on immunosuppressive medications or require antibiotic prophylaxis before dental treatment.
- Patients who are able to read and consent in English.
Who cannot join
- Patients with a tooth requiring RCT retreatment that also presents with periodontal pocket(s) deeper than 5mm
- Patients with a tooth requiring RCT retreatment that also presents with severe crown destruction that would prevent proper rubber dam isolation or an adequate restoration
- Patients with a tooth requiring RCT retreatment that also presents with evidence of vertical root fracture, or cracks with probing defects > 5 mm
- Patients with a tooth requiring RCT retreatment that is deemed unrestorable
- Patients who received antibiotic therapy within the previous 3 months.
- Patients under the age of 16 or those incapable of providing informed consent
Show all 10Show fewer
- Patients with a tooth requiring RCT retreatment that also presents with immature or open apices
- Patients with a tooth requiring RCT retreatment that also presents with apices in the maxillary sinus or those teeth where the apical lesion has eroded the bone of the maxillary sinus floor
- Patients with a tooth requiring RCT retreatment that also presents with apices that are less than 1 mm from the mandibular canal
- Patients with a tooth requiring RCT retreatment that also presents with internal or external root resorption
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
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Can Wang, PhD, 2059341141, cw24@uab.edu
Ashraf F Fouad, DDS,MS, 205-934-5373, afouad@uab.edu
About this study
Official title: Efficacy of a Multisonic System vs. Conventional Therapy in the Disinfection of Molar Retreatment Cases: A Randomized Clinical Trial
Post-treatment apical periodontitis is commonly associated with persistent intracanal infection following root canal treatment. Effective disinfection of the complex root canal system during nonsurgical retreatment remains challenging due to anatomical complexities that may harbor microbial biofilms. Conventional retreatment protocols typically involve nickel-titanium rotary instrumentation combined with irrigation using sodium hypochlorite and activation techniques such as Passive Ultrasonic Irrigation (PUI).
The GentleWave System (GWS) is a minimally invasive irrigation technology designed to enhance tissue dissolution and microbial removal through multisonic energy, advanced fluid dynamics, and negative pressure. Although preliminary studies suggest promising results in root canal disinfection and patient outcomes, high-level clinical evidence comparing GWS with conventional retreatment techniques remains limited, particularly in molar teeth with post-treatment apical periodontitis.
Read more
This randomized clinical study aims to compare the disinfection efficacy of GWS with a conventional nickel-titanium rotary instrumentation protocol combined with PUI in nonsurgical retreatment of molars with post-treatment apical periodontitis. Intracanal bacterial load will be quantified using quantitative polymerase chain reaction (qPCR), and microbial composition will be analyzed using next-generation sequencing (NGS). Residual organic debris will be evaluated using the chairside diagnostic device Endocator and facultative bacterial culturing. Postoperative pain levels will also be recorded to assess short-term clinical outcomes.
The results of this study will provide clinical evidence regarding the comparative effectiveness, safety, and potential advantages of advanced irrigation technology for root canal disinfection in complex retreatment cases.
Read the detailed description
Post-treatment apical periodontitis in root canal-treated teeth is caused by persistent, secondary, or recurrent intra-canal infection. The complex anatomy of the root canal system-including isthmuses, fins, and lateral canals-can limit the effectiveness of conventional instrumentation and irrigation, allowing microbial biofilms to persist. As a result, nonsurgical endodontic retreatment often presents a lower success rate compared with primary root canal treatment.
Conventional retreatment protocols typically involve mechanical debridement using nickel-titanium rotary instrumentation combined with irrigation using sodium hypochlorite. Irrigation activation techniques such as passive ultrasonic irrigation (PUI) are commonly used to improve irrigant penetration and enhance removal of debris and bacteria from complex canal anatomy. However, these techniques may still be limited in their ability to completely eliminate microbial biofilms and may carry a risk of irrigant extrusion.
The GentleWave System (GWS) is an advanced irrigation technology that uses multisonic energy, negative pressure, and optimized fluid dynamics to enhance tissue dissolution and microbial removal throughout the root canal system. This system allows effective disinfection while minimizing the need for extensive mechanical instrumentation, potentially supporting minimally invasive endodontic approaches. Although studies have demonstrated promising results, well-designed randomized clinical trials evaluating its effectiveness in retreatment cases remain limited.
This randomized clinical trial will compare the disinfection efficacy of GWS with a conventional retreatment protocol consisting of nickel-titanium rotary instrumentation combined with PUI in molars diagnosed with post-treatment apical periodontitis. Microbiological samples will be collected before treatment and prior to obturation. Intracanal bacterial load will be quantified using quantitative real-time polymerase chain reaction (qPCR), and microbial community composition will be analyzed using next-generation sequencing (NGS). In addition, residual organic debris will be evaluated using the chairside device Endocator, which provides a rapid quantitative Endoscore to determine the degree of disinfection of each group.
The primary outcomes of the study are reduction in intracanal bacterial load and changes in microbial composition following disinfection. Secondary outcomes include the efficacy of the chairside device Endocator in disinfection of the root canal, compared with PCR-based methods as well as facultative bacterial culturing, and short-term postoperative pain assessment. These findings from this study aim to provide high-quality clinical evidence regarding the comparative effectiveness of advanced irrigation technologies versus conventional disinfection protocols in endodontic retreatment.
- Conditions
- Apical Periodontitis
- Being tested
- GentleWave System, Conventional rotary instrumentation with passive ultrasonic irrigation
- Keywords
- Post-treatment apical periodontitis, Endodontic retreatment, Root canal disinfection, GentleWave System, Passive ultrasonic irrigation, Nickel-titanium rotary instrumentation, Sodium hypochlorite irrigation, Intracanal bacterial load, Root canal microbiome, Quantitative PCR, Next-generation sequencing, Endocator, Postoperative pain
- Medical subject headings
- Periapical Periodontitis, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GentleWave SystemProcedure or surgery
Minimally invasive root canal disinfection using the GentleWave multisonic irrigation system following minimal instrumentation. The system delivers multisonically activated sodium hypochlorite and EDTA solutions under negative pressure to enhance irrigation dynamics and debris removal within the root canal system during nonsurgical endodontic retreatment.
Conventional rotary instrumentation with passive ultrasonic irrigationProcedure or surgery
Conventional nonsurgical endodontic retreatment using nickel-titanium rotary instrumentation followed by passive ultrasonic irrigation (PUI). Irrigation is performed using sodium hypochlorite delivered via a side-vented needle and ultrasonically activated irrigation to enhance canal disinfection after mechanical preparation.
| Study group | Role | What they receive |
|---|---|---|
| GentleWave Disinfection Group | Active comparator | Participants with molars requiring nonsurgical endodontic retreatment will undergo root canal disinfection using the GentleWave System following minimal mechanical instrumentation. Microbiological samples will be collected prior to retreatment and before obturation to evaluate intracanal bacterial load and microbiome composition. Residual organic debris will be assessed using the chairside device Endocator, and postoperative pain will be recorded. Receives: Procedure: GentleWave System |
| Conventional Rotary Instrumentation with Passive Ultrasonic Irrigation | Active comparator | Participants with molars requiring nonsurgical endodontic retreatment will undergo conventional chemomechanical preparation using nickel-titanium rotary instrumentation combined with irrigation using Sodium hypochlorite and activation with Passive Ultrasonic Irrigation. Microbiological samples will be collected prior to retreatment and before obturation to evaluate intracanal bacterial load and microbiome composition. Residual organic debris will be assessed using the chairside device Endocator, and postoperative pain will be recorded. Receives: Procedure: Conventional rotary instrumentation with passive ultrasonic irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of the intracanal Bacterial Load
Change in total bacterial load in the root canal system following disinfection, measured by quantitative real-time polymerase chain reaction (qPCR) targeting the universal 16S rRNA gene. Bacterial load will be quantified from microbiological samples collected before instrumentation (S1) and after completion of the disinfection protocol (S2) to determine the reduction in bacterial load between the two time points.
Measured: During the treatment visit (baseline before instrumentation and immediately after completion of the disinfection protocol).
Root Canal Microbiome Composition
Differences in the prevalence and relative abundance of bacterial taxa in root canal samples before and after disinfection, assessed using next-generation sequencing (NGS) of bacterial 16S rRNA gene amplicons. Alpha diversity and beta diversity metrics will be analyzed to compare microbial community structure between treatment groups.
Measured: During the treatment visit (baseline before instrumentation and immediately after completion of the disinfection protocol).
Secondary outcomes (2)
change of the Residual Intracanal Organic Debris Score
Residual organic debris within the root canal system will be measured using the chairside device Endocator. The device provides a quantitative Endoscore representing the level of intracanal bioburden. Scores will be recorded before instrumentation and after completion of the disinfection protocol to assess debris reduction. Endoscore values will be categorized as follows: (1) 1-25: Low Bioburden; (2) 26-50: Medium Bioburden; (3) 51-100: High Bioburden, as instructed by the device protocol.
Measured: During the treatment visit (before instrumentation and immediately after completion of disinfection).
Post-operative Pain
Patient-reported post-operative pain intensity measured using a numerical rating scale from 0 (no pain) to 10 (worst imaginable pain). Participants will record their pain levels following the treatment procedure using a post-treatment pain diary.
Measured: 1 day, 2 days, 3 days, 5 days, and 7 days after the treatment visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study startJul 2027 (estimated)
- Primary completionJun 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apical PeriodontitisStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- Participants with molar teeth diagnosed with post-treatment apical periodontitis requiring nonsurgical endodontic retreatment will be randomly assigned to one of two parallel treatment groups. The experimental group will receive root canal disinfection using the GentleWave System, while the control group will receive conventional chemomechanical preparation using nickel-titanium rotary instrumentation combined with Passive Ultrasonic Irrigation. Microbiological samples will be collected before treatment and prior to obturation to quantify intracanal bacterial load and evaluate microbial composition. Residual organic debris will be assessed using the chairside device Endocator and compared with PCR-based method as well as facultative bacterial culturing, and postoperative pain will be recorded as a secondary clinical outcome.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Can Wang, University of Alabama at Birmingham
- Investigators
- Can Wang, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07469150
- Sponsor's protocol ID
- IRB-300015590
- Other IDs
- Pending
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2026
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Multisonic System vs. Conventional Therapy in the Disinfection of Molar Retreatment Cases: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07469150
- Acronym / sponsor ID
- IRB-300015590
- Conditions
- Apical Periodontitis
- Keywords
- Post-treatment apical periodontitis, Endodontic retreatment, Root canal disinfection, GentleWave System, Passive ultrasonic irrigation, Nickel-titanium rotary instrumentation, Sodium hypochlorite irrigation, Intracanal bacterial load
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Jul 2027 (estimated)
- Primary completion
- Jun 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 13 Mar 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.
Post-treatment apical periodontitis is commonly associated with persistent intracanal infection following root canal treatment. Effective disinfection of the complex root canal system during nonsurgical retreatment remains challenging due to anatomical complexities that may harbor microbial biofilms. Conventional retreatment protocols typically involve nickel-titanium rotary instrumentation combined with irrigation using sodium hypochlorite and activation techniques such as Passive Ultrasonic Irrigation (PUI).
The GentleWave System (GWS) is a minimally invasive irrigation technology designed to enhance tissue dissolution and microbial removal through multisonic energy, advanced fluid dynamics, and negative pressure. Although preliminary studies suggest promising results in root canal disinfection and patient outcomes, high-level clinical evidence comparing GWS with conventional retreatment techniques remains limited, particularly in molar teeth with post-treatment apical periodontitis.
This randomized clinical study aims to compare the disinfection efficacy of GWS with a conventional nickel-titanium rotary instrumentation protocol combined with PUI in nonsurgical retreatment of molars with post-treatment apical periodontitis. Intracanal bacterial load will be quantified using quantitative polymerase chain reaction (qPCR), and microbial composition will be analyzed using next-generation sequencing (NGS). Residual organic debris will be evaluated using the chairside diagnostic device Endocator and facultative bacterial culturing. Postoperative pain levels will also be recorded to assess short-term clinical outcomes.
The results of this study will provide clinical evidence regarding the comparative effectiveness, safety, and potential advantages of advanced irrigation technology for root canal disinfection in complex retreatment cases.
Detailed description
Post-treatment apical periodontitis in root canal-treated teeth is caused by persistent, secondary, or recurrent intra-canal infection. The complex anatomy of the root canal system-including isthmuses, fins, and lateral canals-can limit the effectiveness of conventional instrumentation and irrigation, allowing microbial biofilms to persist. As a result, nonsurgical endodontic retreatment often presents a lower success rate compared with primary root canal treatment.
Conventional retreatment protocols typically involve mechanical debridement using nickel-titanium rotary instrumentation combined with irrigation using sodium hypochlorite. Irrigation activation techniques such as passive ultrasonic irrigation (PUI) are commonly used to improve irrigant penetration and enhance removal of debris and bacteria from complex canal anatomy. However, these techniques may still be limited in their ability to completely eliminate microbial biofilms and may carry a risk of irrigant extrusion.
The GentleWave System (GWS) is an advanced irrigation technology that uses multisonic energy, negative pressure, and optimized fluid dynamics to enhance tissue dissolution and microbial removal throughout the root canal system. This system allows effective disinfection while minimizing the need for extensive mechanical instrumentation, potentially supporting minimally invasive endodontic approaches. Although studies have demonstrated promising results, well-designed randomized clinical trials evaluating its effectiveness in retreatment cases remain limited.
This randomized clinical trial will compare the disinfection efficacy of GWS with a conventional retreatment protocol consisting of nickel-titanium rotary instrumentation combined with PUI in molars diagnosed with post-treatment apical periodontitis. Microbiological samples will be collected before treatment and prior to obturation. Intracanal bacterial load will be quantified using quantitative real-time polymerase chain reaction (qPCR), and microbial community composition will be analyzed using next-generation sequencing (NGS). In addition, residual organic debris will be evaluated using the chairside device Endocator, which provides a rapid quantitative Endoscore to determine the degree of disinfection of each group.
The primary outcomes of the study are reduction in intracanal bacterial load and changes in microbial composition following disinfection. Secondary outcomes include the efficacy of the chairside device Endocator in disinfection of the root canal, compared with PCR-based methods as well as facultative bacterial culturing, and short-term postoperative pain assessment. These findings from this study aim to provide high-quality clinical evidence regarding the comparative effectiveness of advanced irrigation technologies versus conventional disinfection protocols in endodontic retreatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants with molar teeth diagnosed with post-treatment apical periodontitis requiring nonsurgical endodontic retreatment will be randomly assigned to one of two parallel treatment groups. The experimental group will receive root canal disinfection using the GentleWave System, while the control group will receive conventional chemomechanical preparation using nickel-titanium rotary instrumentation combined with Passive Ultrasonic Irrigation. Microbiological samples will be collected before treatment and prior to obturation to quantify intracanal bacterial load and evaluate microbial composition. Residual organic debris will be assessed using the chairside device Endocator and compared with PCR-based method as well as facultative bacterial culturing, and postoperative pain will be recorded as a secondary clinical outcome.
| Arm | Type | Receives |
|---|---|---|
| GentleWave Disinfection Group | Active comparator | Procedure: GentleWave SystemParticipants with molars requiring nonsurgical endodontic retreatment will undergo root canal disinfection using the GentleWave System following minimal mechanical instrumentation. Microbiological samples will be collected prior to retreatment and before obturation to evaluate intracanal bacterial load and microbiome composition. Residual organic debris will be assessed using the chairside device Endocator, and postoperative pain will be recorded. |
| Conventional Rotary Instrumentation with Passive Ultrasonic Irrigation | Active comparator | Procedure: Conventional rotary instrumentation with passive ultrasonic irrigationParticipants with molars requiring nonsurgical endodontic retreatment will undergo conventional chemomechanical preparation using nickel-titanium rotary instrumentation combined with irrigation using Sodium hypochlorite and activation with Passive Ultrasonic Irrigation. Microbiological samples will be collected prior to retreatment and before obturation to evaluate intracanal bacterial load and microbiome composition. Residual organic debris will be assessed using the chairside device Endocator, and postoperative pain will be recorded. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Molars showing radiographic evidence of post-treatment apical periodontitis: a lesion that exceeds 3 mm in diameter on one or more roots.
- Evidence from periapical and CBCT examination suggests that retreatment is a viable option, i.e., there are low risks of vertical root fracture, no major root canal obstruction, evidence of coronal leakage, and potential improvement on the previous treatment.
- The initial root canal therapy was performed at least 2 years previously, or more than 1 year if the patient has signs and symptoms or symptomatic disease (pain, swelling, or sinus tracts).
- Patients show no chronic systemic disease that may influence the outcome of care, such as uncontrolled diabetes, autoimmune disease, malignancy treated with chemotherapy or patients who are on immunosuppressive medications or require antibiotic prophylaxis before dental treatment.
- Patients who are able to read and consent in English.
Key exclusion criteria (10 listed)
- Patients with a tooth requiring RCT retreatment that also presents with periodontal pocket(s) deeper than 5mm
- Patients with a tooth requiring RCT retreatment that also presents with severe crown destruction that would prevent proper rubber dam isolation or an adequate restoration
- Patients with a tooth requiring RCT retreatment that also presents with evidence of vertical root fracture, or cracks with probing defects > 5 mm
- Patients with a tooth requiring RCT retreatment that is deemed unrestorable
- Patients who received antibiotic therapy within the previous 3 months.
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 |
|---|---|---|
| GentleWave SystemMinimally invasive root canal disinfection using the GentleWave multisonic irrigation system following minimal instrumentation. The system delivers multisonically activated sodium hypochlorite and EDTA solutions under negative pressure to enhance irrigation dynamics and debris removal within the root canal system during nonsurgical endodontic retreatment. | Procedure or surgery | GentleWave Disinfection Group |
| Conventional rotary instrumentation with passive ultrasonic irrigationConventional nonsurgical endodontic retreatment using nickel-titanium rotary instrumentation followed by passive ultrasonic irrigation (PUI). Irrigation is performed using sodium hypochlorite delivered via a side-vented needle and ultrasonically activated irrigation to enhance canal disinfection after mechanical preparation. | Procedure or surgery | Conventional Rotary Instrumentation with Passive Ultrasonic Irrigation |
Primary outcome
change of the intracanal Bacterial Load
Time frame: During the treatment visit (baseline before instrumentation and immediately after completion of the disinfection protocol).
Change in total bacterial load in the root canal system following disinfection, measured by quantitative real-time polymerase chain reaction (qPCR) targeting the universal 16S rRNA gene. Bacterial load will be quantified from microbiological samples collected before instrumentation (S1) and after completion of the disinfection protocol (S2) to determine the reduction in bacterial load between the two time points.
Root Canal Microbiome Composition
Time frame: During the treatment visit (baseline before instrumentation and immediately after completion of the disinfection protocol).
Differences in the prevalence and relative abundance of bacterial taxa in root canal samples before and after disinfection, assessed using next-generation sequencing (NGS) of bacterial 16S rRNA gene amplicons. Alpha diversity and beta diversity metrics will be analyzed to compare microbial community structure between treatment groups.
2 secondary outcomes
change of the Residual Intracanal Organic Debris Score
Time frame: During the treatment visit (before instrumentation and immediately after completion of disinfection).
Post-operative Pain
Time frame: 1 day, 2 days, 3 days, 5 days, and 7 days after the treatment visit
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 8 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Can Wang, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GentleWave System and Conventional rotary instrumentation with passive ultrasonic irrigation in people with Apical Periodontitis, run by University of Alabama at Birmingham 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 10 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: opening soon, as of the sponsor's last update on 8 Apr 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 Can Wang, PhD (205-934-1141, cw24@uab.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of the intracanal Bacterial Load (time frame: During the treatment visit (baseline before instrumentation and immediately after completion of the disinfection protocol).). The study lists 2 primary outcomes in all. 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 8 Apr 2026.