Efficacy of Different Disinfection Technologies in Molar Non-Surgical Retreatment

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT07469150
Status
Not Yet Recruiting

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Conditions

  • Apical Periodontitis

Eligibility Criteria

Sex
ALL
Age
16 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GentleWave System — PROCEDURE
    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 irrigation — PROCEDURE
    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 Details

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.

Key Dates

Start date
Jul 31, 2027
Status verified
Mar 2026
Primary completion
Jun 30, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: GentleWave Disinfection Group
    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.
  • Active Comparator: Conventional Rotary Instrumentation with Passive Ultrasonic Irrigation
    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.

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). ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233
Can Wang, PhD
[email protected]
2059341141
Ashraf F Fouad, DDS,MS
[email protected]
205-934-5373
Can Wang, PhD (PRINCIPAL_INVESTIGATOR)
Ashraf F Fouad, DDS, MS (SUB_INVESTIGATOR)

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By research site
University of Alabama at Birmingham· Birmingham, AL

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