Root Canal Therapy for Tooth Pulp Necrosis

Overseen By Abhishek Parolia, PhD, MDS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Abhishek Parolia

Must not be taking: Corticosteroids, Antibiotics

Disqualifiers: Diabetes, Immune compromised, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests three different root canal procedures to assess their impact on bacteria in teeth with dead pulp (the soft center of a tooth) and related gum issues. The treatments under study include EdgePro Laser Root Canal Therapy, GentleWave System Root Canal Therapy, and ProUltra Piezo Ultrasonic with EndoUltra Tips Root Canal Therapy. Researchers will check participants' bacteria levels before and after the procedures. Ideal candidates for this trial have a single-canal tooth that does not respond to cold or electric tests, indicating nonviable pulp. As an unphased trial, this study provides an opportunity to explore innovative treatments that could enhance dental health.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude people who are taking corticosteroids or have taken antibiotics in the last 3 months.

What prior data suggests that these root canal procedures are safe?

Research shows that EdgePro Laser Root Canal Therapy is safe. Studies indicate it effectively cleans and kills up to 99% of bacteria in root canals. It also has FDA clearance, meeting certain safety standards for use.

The GentleWave System Root Canal Therapy is also considered safe, with a high success rate of 97.3% in treating root canals. While side effects can occur, no major safety issues have been widely reported.

For The ProUltra Piezo Ultrasonic with EndoUltra Tips Root Canal Therapy, less specific safety data is available. However, this method uses controlled ultrasonic power, which dentists adjust based on their experience to ensure safety.

Overall, these treatments are generally well-tolerated and effective in reducing bacteria in root canals. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these new root canal therapies because they offer innovative approaches to cleaning and disinfecting tooth canals, which is crucial for treating tooth pulp necrosis. Traditional root canal treatments typically involve mechanical instrumentation and chemical irrigation. However, the EdgePro Laser therapy uses advanced laser technology to precisely target and eliminate bacteria. The GentleWave System utilizes acoustic energy to clean complex root canal systems more thoroughly than conventional methods. Meanwhile, the ProUltra Piezo Ultrasonic with EndoUltra Tips employs ultrasonic energy to enhance cleaning efficiency. These methods aim to improve treatment outcomes by offering more effective bacteria removal and potentially reducing treatment time.

What evidence suggests that this trial's root canal therapies could be effective for reducing bacteria in tooth pulp necrosis?

This trial will compare three different root canal therapies. Research shows that the EdgePro Laser Root Canal Therapy, one of the treatments in this trial, effectively kills up to 99% of bacteria commonly found in root canals. Studies have found that it cleans and disinfects better than standard methods. The GentleWave System, another treatment option in this trial, also demonstrates a high success rate of 97.3% in root canal treatments. It cleans effectively without traditional tools, preserving the tooth's structure. For the ProUltra Piezo Ultrasonic system, the third treatment in this trial, research indicates that its continuous ultrasonic irrigation can improve treatment success by reducing bacteria. All three methods show promise in effectively treating bacterial infections in root canals. ^{1 2 3 6 7}

Who Is on the Research Team?

Abhishek Parolia, PhD, MDS

Principal Investigator

University of Iowa

Are You a Good Fit for This Trial?

This trial is for individuals with a specific dental condition where the tooth's pulp (the inner part) has died, often referred to as 'tooth necrosis'. Participants should not have had any root canal treatment on the affected tooth before joining this study.

Inclusion Criteria

Tooth with no response to cold and electric pulp testing (done at screening)

My tooth's nerve is dead, causing infection at the root, confirmed by tests.

My premolar has one canal and its walls are intact.

Exclusion Criteria

I have facial pain not caused by my teeth.

My teeth are very loose.

Patients who are pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo root canal procedures with supplementary disinfection approaches to assess bacterial reduction

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in bacterial count after the root canal procedure

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• EdgePro Laser Root Canal Therapy
• GentleWave System Root Canal Therapy
• The ProUltra Piezo Ultrasonic with EndoUltra Tips Root Canal Therapy

Trial Overview The study aims to compare three different root canal treatments: GentleWave System, EdgePro Laser Therapy, and ProUltra Piezo Ultrasonic with EndoUltra Tips. It will assess how well each method reduces bacteria in infected root canals.

How Is the Trial Designed?

Group I: The ProUltra Piezo Ultrasonic with EndoUltra Tips Root Canal Therapy Experimental Treatment 1 Intervention

Sterile paper points will be inserted into the root canal at 3 time points: (i) before instrumentation, (ii) after washing the canal with 10% sodium thiosulfate, and (iii) after the ProUltra Piezo Ultrasonic with EndoUltra Tips root canal therapy has been completed. The paper points will collect bacteria, which will be analyzed via real-time Polymerase Chain Reaction to assess bacterial counts.

Group II: GentleWave System Root Canal Therapy Experimental Treatment 1 Intervention

Sterile paper points will be inserted into the root canal at 3 time points: (i) before instrumentation, (ii) after washing the canal with 10% sodium thiosulfate, and (iii) after the GentleWave System root canal therapy has been completed. The paper points will collect bacteria, which will be analyzed via real-time Polymerase Chain Reaction to assess bacterial counts.

Group III: EdgePro Laser Root Canal Therapy Experimental Treatment 1 Intervention

Sterile paper points will be inserted into the root canal at 3 time points: (i) before instrumentation, (ii) after washing the canal with 10% sodium thiosulfate, and (iii) after the EdgePro Laser root canal therapy has been completed. The paper points will collect bacteria, which will be analyzed via real-time Polymerase Chain Reaction to assess bacterial counts.

EdgePro Laser Root Canal Therapy is already approved in United States for the following indications:

Approved in United States as EdgePRO Laser-Assisted Microfluidic Irrigation Device for:

• Root canal cleaning and disinfection

Who Is Running the Clinical Trial?

Abhishek Parolia

Lead Sponsor

Trials

1

Recruited

90+

Published Research Related to This Trial

The GentleWave System was found to be significantly more effective at reducing biofilm in the roots of molars compared to conventional rotary instrumentation combined with passive ultrasonic activation, with a notable difference in both apical and middle regions of the roots (p = 0.001).

In the study involving 47 human molars inoculated with Enterococcus faecalis, the GentleWave System showed a significant reduction in biofilm presence compared to untreated controls (p = 0.003), indicating its potential as a superior disinfection method in endodontic treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Analysis of Biofilm Removal Efficacy by Multisonic Ultracleaning System and Passive Ultrasonic Activation. Choi, HW., Park, SY., Kang, MK., et al.[2020]

In a six-month clinical study involving 89 patients, the GentleWave® System demonstrated a high cumulative success rate of 97.4% for healing molars after root canal treatment.

Two key factors associated with successful healing were identified: the presence of apical periodontitis before treatment and the completion of the procedure in a single visit, highlighting the importance of these factors in treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Six-month healing success rates after endodontic treatment using the novel GentleWave™ System: The pure prospective multi-center clinical study. Sigurdsson, A., Le, KT., Woo, SM., et al.[2020]

The GentleWave System (GWS) combined with either minimally invasive technique (MIT) or conventional instrumentation technique (CIT) was found to be the most effective in removing Enterococcus faecalis lipoteichoic acid (LTA) from infected root canals, with both methods showing similar efficacy.

In a study involving 60 extracted human teeth, GWS treatments resulted in more root canals having undetectable levels of E. faecalis LTA after treatment compared to other methods, highlighting its potential for improved infection control in endodontic procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of GentleWave System and Passive Ultrasonic Irrigation with Minimally Invasive and Conventional Instrumentation Technique against Enterococcus faecalis Lipoteichoic Acid in Infected Root Canals. Velardi, JP., Alquria, TA., Alfirdous, RA., et al.[2022]

In a randomized clinical trial comparing the GentleWave System (GWS) to standard irrigation methods in endodontic treatment, both groups experienced similar rates of postoperative pain, with 72.2% in the standard group and 83.3% in the GWS group reporting pain.

Despite no significant difference in pain incidence or intensity between the two methods, both groups showed a statistically significant decrease in pain over time after treatment, indicating that pain generally lessens as time passes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative Pain after Treatment Using the GentleWave System: A Randomized Controlled Trial. Grigsby, D., Ordinola-Zapata, R., McClanahan, SB., et al.[2023]

In a study involving 20 human mandibular molars, both passive ultrasonic irrigation (PUI) and the GentleWave system significantly improved the removal of remaining filling materials from oval-shaped root canals after initial treatment, although neither method completely cleared the canals.

PUI was found to be more effective than the GentleWave system, removing about 18% of the remaining filling material compared to 10% with GentleWave, highlighting PUI's superior efficacy in enhancing root canal cleaning during endodontic retreatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Passive Ultrasonic Irrigation and GentleWave System as Adjuvants in Endodontic Retreatment. Crozeta, BM., Chaves de Souza, L., Correa Silva-Sousa, YT., et al.[2020]

The GentleWave system (GW) demonstrated superior organic dissolution and bacterial reduction compared to conventional irrigation methods, making it an effective option for root canal treatments based on a review of 24 studies, including 4 clinical trials.

Clinically, the GW system achieved a high success rate of 97.3% in endodontic treatments, with postoperative pain levels comparable to traditional methods, indicating its safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of the GentleWave system on root canal treatment: a narrative review. Coaguila-Llerena, H., Gaeta, E., Faria, G.[2022]

The GentleWave™ System generates negative apical pressures during root canal cleaning, which can enhance safety by reducing the risk of pushing debris beyond the root tip, unlike conventional syringe irrigation that produces positive pressures.

In a study involving extracted maxillary molars, the GentleWave™ System consistently created negative pressures between -13.07 and -17.19 mmHg, while syringe irrigation resulted in positive pressures ranging from 6.46 to 110.34 mmHg, indicating a significant difference in pressure dynamics during the irrigation process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Apical pressure created during irrigation with the GentleWave™ system compared to conventional syringe irrigation. Haapasalo, M., Shen, Y., Wang, Z., et al.[2022]

The GentleWave System (GWS) demonstrated a significantly higher cleaning efficacy in root canals compared to conventional rotary instrumentation, achieving a 97.2% cleaning rate in certain canal regions versus 67.8% with traditional methods.

In a study involving 45 freshly extracted molars, the GWS effectively reduced residual debris in the mesiobuccal and mesiolingual canals, indicating its potential to improve endodontic treatment outcomes and reduce the risk of persistent infection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Root Canal Debridement of Human Molars Using the GentleWave System. Molina, B., Glickman, G., Vandrangi, P., et al.[2017]

Citations

1. withpower.com withpower.com/trial/phase-necrosis-7-2024-fc85a

Root Canal Therapy for Tooth Pulp Necrosis The GentleWave System has been studied in clinical trials and reviews, showing a high success rate of 97.3% for endodontic treatment and no significant ...

2. brasselerusadental.com brasselerusadental.com/edgeproendo

EdgePro Endodontic Laser Research has shown EdgePRO™ laser technology provides highly effective cleaning, debridement, and kills up to 99% of bacteria commonly found in the root canal.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06554366

Bacterial Load Reduction by GentleWave and EdgePro ... The purpose of this study is to compare the efficacy of GentleWave versus EdgePro irrigation in the disinfection of infected root canals of human permanent ...

4. scholarworks.indianapolis.iu.edu scholarworks.indianapolis.iu.edu/items/d3bc8bc1-620e-46d3-bed3-fa40c5241622

Bactericidal Efficacy of EdgePRO Er,Cr:YSGG Laser-Activated ... EdgePro LAI displayed statistically significant superior cleaning and disinfection of infected canal space compared to teeth treated with standard needle ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12103479/

Recent innovations in endodontic irrigation and effects on ... Irrigant activation demonstrated higher efficiency in smear layer removal from root canal systems compared to conventional irrigation techniques.

6. northcountyendo.com northcountyendo.com/technology/edgepro-laser-assisted-endodontic-technology/

EdgePro Laser-Assisted Endodontic Technology EdgePro® is a proprietary laser-assisted endodontic technology that generates light-absorbed energy waves that can help remove up to 99% of the bacteria ...

7. biolase.com biolase.com/blog/biolase-and-edgeendo-announce-fda-510k-clearance-of-new-edgepro-laser-assisted-microfluidic-irrigation-device-for-endodontists/

BIOLASE and EdgeEndo Announce FDA 510(k) ... BIOLASE and EdgeEndo Announce FDA 510(k) Clearance of New EdgePRO Laser-Assisted Microfluidic Irrigation Device for Endodontists. The EdgePRO ...