Irrigation Techniques for Postoperative Pain

Overseen By Waleed Elmallah, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Cleveland Dental Institute

Disqualifiers: Pulp necrosis, Apical periodontitis, Periodontal disease, others

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

Compensation: Varies

Number of Visits: 6

Duration: 1 day

84 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess how different cleaning techniques during root canal therapy affect post-treatment pain. It compares the IVAC irrigation approach, a device-based cleaning method, with other methods such as ultrasonic and negative pressure irrigation. Participants will rate their pain at various intervals after treatment to determine which method provides the most relief. Individuals with a painful first molar tooth (specifically the lower back tooth) due to acute pulpitis (inflammation of the dental pulp) and no significant other dental issues may be suitable for this trial. As an unphased trial, this study allows participants to contribute to important research that could enhance dental care techniques.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that these irrigation techniques are safe for postoperative pain management?

Research has shown that the IVAC irrigation method and other techniques used in the trial are generally safe.

For the IVAC irrigation method, studies indicate it employs a mix of gentle suction and sound waves. This approach helps maintain safety by reducing the risk of pushing debris beyond the root tip during a root canal, which can cause pain or infection.

The gentle suction technique is known for reducing pain after the procedure. Studies have found it causes less pain compared to older methods that use pressure to push fluids, which can move debris into sensitive areas.

Ultrasonic irrigation, which uses sound waves to clean the root canal, is also well-tolerated. This technique often results in mild pain after the procedure, but it usually doesn't last long.

Overall, these irrigation methods appear safe for root canal treatments, with most patients experiencing only mild and temporary discomfort. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores advanced irrigation techniques that could significantly improve postoperative pain management in dental procedures. Unlike conventional methods that use simple side-vented needles, this trial investigates using apical negative pressure, ultrasonic activation, and a combination of both with the IVAC device. These techniques aim to enhance the effectiveness of irrigation by ensuring deeper and more thorough cleaning of the root canal, potentially leading to less pain and faster recovery. By comparing these innovative methods to the standard approach, the trial seeks to uncover which technique offers the most benefits, paving the way for improved patient outcomes in root canal treatments.

What evidence suggests that this trial's irrigation techniques could be effective for reducing postoperative pain?

This trial will compare different irrigation techniques for postoperative pain management. Studies have shown that the iVac irrigation method, one of the techniques being tested, effectively cleans and disinfects root canals, potentially reducing pain after the procedure. Research has demonstrated that another technique under study, negative pressure irrigation, significantly decreases pain compared to traditional methods. Additionally, ultrasonic irrigation, also being tested, has been associated with better results by removing bacteria and reducing toxins in the root canal. Overall, these advanced techniques show promise in lowering pain levels after root canal treatment. ^{2 3 4 6 7}

Who Is on the Research Team?

Ahmed A Hashem, PhD

Principal Investigator

Cleveland Dental Institute

Are You a Good Fit for This Trial?

This trial is for at least 84 individuals experiencing pain who require root canal therapy. Participants should be suitable for the same endodontic procedure but cannot have conditions that would exclude them from using any of the irrigation methods being tested.

Inclusion Criteria

Medically free patients

I am between 20-50 years old with a painful tooth due to nerve inflammation.

Exclusion Criteria

Vertical root fracture

Radiographic apical radiolucency

I have gum disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo root canal therapy using various irrigation techniques including IVAC, ultrasonic, and traditional methods

1 day

1 visit (in-person)

Follow-up

Participants are monitored for postoperative pain levels at multiple time intervals using a numerical rate scale

72 hours

5 assessments (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• IVAC Irrigation Approach
• Negative Pressure Irrigation Technique
• Ultrasonic Irrigation Technique

Trial Overview The study compares four different techniques to manage pain after a root canal: traditional irrigation, ultrasonic, apical negative pressure, and a new method called iVac. Pain levels will be measured using a numerical scale at various times post-treatment.

How Is the Trial Designed?

Group I: Irrigant activation with negative pressure Experimental Treatment 1 Intervention

Final irrigant activation will be performed with apical negative pressure

Group II: Irrigant activation with both Ultrasonic and negative pressure Experimental Treatment 1 Intervention

Final irrigation with a combination of ultrasonic and apical negative pressure using the IVAC device.

Group III: Irrigant activation with Ultrasonic Experimental Treatment 1 Intervention

Final irrigant activation will be done by ultrasonic

Group IV: Conventional root canal treatment Active Control 1 Intervention

Irrigation will be performed with side vented needles only

IVAC Irrigation Approach is already approved in United States for the following indications:

Approved in United States as iVac Apical Negative Pressure Irrigation and Activation System for:

• Root canal therapy
• Endodontic treatment

Who Is Running the Clinical Trial?

Cleveland Dental Institute

Lead Sponsor

Trials

6

Recruited

440+

Published Research Related to This Trial

The study evaluated the effectiveness of different irrigation techniques in root canals using 64 single-rooted teeth, finding that the combination of apical negative pressure (ANP) and passive ultrasonic irrigation (PUI) significantly improved the penetration of the irrigating contrast solution (ICS) both up to the working length and into lateral canals.

The results showed that the ANP and PUI combination achieved the deepest ICS penetration, particularly in lateral canals at various depths, indicating that this combined approach may enhance the cleaning efficacy in endodontic treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of irrigant penetration up to working length and into simulated lateral canals using various irrigating techniques. Spoorthy, E., Velmurugan, N., Ballal, S., et al.[2015]

In a study involving 49 root canals from three dogs with apical periodontitis, apical negative pressure irrigation (ANP) showed a milder inflammatory response compared to conventional positive pressure irrigation (PP), suggesting it may be a better option for clinical use.

Despite no significant differences in overall periapical lesion size among the three irrigation methods, ANP provided more consistent results in histopathological evaluations, indicating its potential advantages in promoting periapical repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tissue response to root canal irrigation systems in dogs' teeth with apical periodontitis. Cohenca, N., Romualdo, PC., da Silva, LA., et al.[2021]

In a study involving immature dogs' teeth with apical periodontitis, the use of apical negative pressure irrigation (EndoVac system) resulted in better revascularization and repair compared to apical positive pressure irrigation with an antibiotic dressing, particularly in terms of mineralized tissue formation and connective tissue structure.

The findings suggest that sodium hypochlorite irrigation with the EndoVac system is an effective disinfection method for treating apical periodontitis, potentially eliminating the need for intracanal antibiotics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Revascularization and periapical repair after endodontic treatment using apical negative pressure irrigation versus conventional irrigation plus triantibiotic intracanal dressing in dogs' teeth with apical periodontitis. da Silva, LA., Nelson-Filho, P., da Silva, RA., et al.[2013]

The new apical negative pressure (ANP) irrigation system demonstrated a significantly lower rate of irrigant extrusion compared to the EndoVac (EV) system, making it a safer option for treating immature teeth.

Both the ANP and EV systems effectively removed the smear layer from root canals, showing no significant difference in efficacy, but both were superior to the control group using distilled water.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison between two negative pressure irrigation techniques in simulated immature tooth: an ex vivo study. Jamleh, A., Fukumoto, Y., Takatomo, Y., et al.[2018]

In a study comparing two root canal disinfection techniques in immature dog teeth with apical periodontitis, both the EndoVac system (apical negative pressure irrigation) and conventional irrigation with triantibiotic dressing showed significant bacterial reduction after treatment.

The EndoVac system achieved similar efficacy in eliminating bacteria as the conventional method, suggesting that intracanal antibiotics may not be necessary for effective disinfection in these cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Apical negative pressure irrigation versus conventional irrigation plus triantibiotic intracanal dressing on root canal disinfection in dog teeth. Cohenca, N., Heilborn, C., Johnson, JD., et al.[2010]

In a study involving 60 patients with symptomatic irreversible pulpitis, the use of laser irrigation activation systems (SWEEPS and PIPS) significantly reduced postoperative pain compared to conventional irrigation methods, with the most notable pain reduction observed in the SWEEPS group.

The results indicated that all irrigation activation methods led to a decrease in pain over time, but laser-activated systems were more effective, highlighting their potential for improving patient comfort during root canal treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative analysis of reduction in pain scores after single visit root canal treatment using endodontic irrigation protocols, namely, Conventional needle irrigation, PUI, PIPS and SWEEPS: A randomized control trial. Mittal, N., Baranwal, HC., Gupta, S., et al.[2023]

In a study involving 116 patients with symptomatic irreversible pulpitis, the EndoVac system (negative pressure irrigation) resulted in significantly less postoperative pain compared to conventional needle irrigation (positive pressure) at 6, 24, and 48 hours after treatment.

Both irrigation methods showed a decrease in pain intensity over time, but the EndoVac system was associated with a more comfortable recovery experience immediately following endodontic therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Apical Positive and Negative Pressure Irrigation Methods on Postoperative Pain in Mandibular Molar Teeth with Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial. Topçuoğlu, HS., Topçuoğlu, G., Arslan, H.[2019]

Citations

1. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/aej.12973?af=R

Effectiveness of the iVac System Compared to ... This in vitro study evaluated the effectiveness of irrigation techniques (IT)—conventional irrigation (CI), ultrasonic activation (UA), and iVac ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10642269/

Irrigants and irrigation activation systems in Endodontics - PMC The effectiveness of irrigation depends on both the mode of distribution and the irrigant properties . Conventional irrigation depends purely on the positive ...

3. trial.medpath.com trial.medpath.com/clinical-trial/449731e56dfb00ad/incidence-postoperative-pain-apical-negative-pressure-ultrasonics-mandibular-molar-teeth

Postoperative Pain After Activation of Irrigant | MedPath The purpose of this research is to analyze the levels of pain after cleaning and shaping in individuals who are receiving root canal therapy using the IVAC ...

4. pac-dent.com pac-dent.com/products/ivac%E2%84%A2

iVac® Apical Negative Pressure Irrigation and Activation ... It can effectively clean and disinfect irregularities of the root canal system with the action of continuous ultrasonic irrigation, 4, 5, 6. • The polymer ...

5. researchgate.net researchgate.net/publication/394074760_Effectiveness_of_the_iVac_System_Compared_to_Conventional_Irrigation_and_Ultrasonic_Activation_in_Reducing_Microbial_Biofilm_Lipopolysaccharides_and_Apical_Extrusion

Effectiveness of the iVac System Compared to ... This in vitro study evaluated the effectiveness of irrigation techniques (IT)—conventional irrigation (CI), ultrasonic activation (UA), and iVac system ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06528574

NCT06528574 | Postoperative Pain After Activation of Irrigant The purpose of this research is to analyze the levels of pain after cleaning and shaping in individuals who are receiving root canal therapy using the IVAC ...

7. pearsondental.com pearsondental.com/flyers/iVacFlyer.pdf

Apical Negative Pressure Irrigation Activation System THE BEST OF ALL IRRIGATION SYSTEMS TOGETHER IN A SAFE AND. INTUITIVE PRODUCT. • The iVac™ uses apical negative pressure with concomitant irrigation, which ...