Study of Disinfection Technologies for Root Canal Retreatment

This study is comparing two different methods for disinfecting root canals during a retreatment procedure. The goal is to see which method is better at removing bacteria from teeth that have had a root canal before but still have an infection (apical periodontitis). One method uses the GentleWave System, which is a minimally invasive way to clean the root canal using special liquids and energy. The other method uses traditional tools (nickel-titanium rotary instrumentation) along with ultrasonic cleaning. Researchers will measure the amount and types of bacteria in the root canal before and after treatment to see how well each method works. You might be able to join if you are 16 or older and have a molar tooth with an infection after a previous root canal, and your dentist believes retreatment is a good option for you.

Study design
This study plans to enroll 60 participants to compare two different root canal disinfection procedures. It is an interventional study, meaning participants will receive one of the study treatments.
What's involved
You will have measurements taken of the bacteria in your root canal before and immediately after the disinfection procedure during your treatment visit.
Compensation
Not stated in the trial record.
Follow-up
The primary measurements for this study are taken during the treatment visit, before and immediately after the disinfection protocol.

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NCT07469150

Efficacy of Different Disinfection Technologies in Molar Non-Surgical Retreatment

Not Yet Recruiting
NAAges 16+InterventionalTreatment
University of Alabama at Birmingham
~60 participants
Updated 2026-04-08 on ClinicalTrials.gov
What's tested:GentleWave SystemConventional rotary instrumentation with passive ultrasonic irrigation

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
change of the intracanal Bacterial Load
Measured over During the treatment visit (baseline before instrumentation and immediately after completion of the disinfection protocol).
+1 more outcome measured
Apical Periodontitis
1 sites across 1 states
Alabama1
  • Can Wang, PhD · PRINCIPAL_INVESTIGATOR · University of Alabama at Birmingham

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Eligibility criteria

Inclusion

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.

Exclusion

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
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
  • change of the intracanal Bacterial LoadDuring 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 CompositionDuring 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.