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

Trial Summary

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 data supports the effectiveness of the treatment for postoperative pain?

Research shows that using apical negative pressure irrigation can improve the cleaning of root canals by better removing debris and bacteria, which may help reduce pain after procedures. Additionally, combining this technique with ultrasonic irrigation can enhance the penetration of cleaning solutions, potentially leading to better outcomes. ^{1 2 3 4 5}

Is the irrigation technique generally safe for humans?

The available research primarily involves animal studies, particularly in dogs, and does not provide direct safety data for humans. Therefore, there is no specific safety information available for humans regarding these irrigation techniques. ^{1 2 3 5 6}

How does the IVAC Irrigation Approach differ from other treatments for postoperative pain?

The IVAC Irrigation Approach is unique because it uses a combination of negative pressure and ultrasonic techniques to clean and disinfect root canals, which may enhance the penetration of cleaning solutions and reduce postoperative pain compared to conventional methods that use positive pressure. ^{1 2 3 5 7}

What is the purpose of this trial?

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 irrigation approach, and those who are treated with ultrasonic irrigation techniques, negative pressure irrigation technique and traditional irrigation techniques. PICOTS Question: Does the new Dent's iVac irrigation protocol has an effect on reduction of postoperative pain By enlisting at least 84 suitable individuals who are undergoing the identical endodontic procedure. pain will be measures by assessing pain levels through a standardized numerical rate scale (NRS) at certain time intervals after root canal treatment, 6 hours, 12 hours, 24 hours, 48 hours, and 72 hours.

Research Team

Ahmed A Hashem, PhD

Principal Investigator

Cleveland Dental Institute

Eligibility Criteria

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

I have gum disease.

Vertical root fracture

Radiographic apical radiolucency

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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 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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Apical negative pressure irrigation versus conventional irrigation plus triantibiotic intracanal dressing on root canal disinfection in dog teeth. [2010]

2. England pubmed.ncbi.nlm.nih.gov

Comparison of irrigant penetration up to working length and into simulated lateral canals using various irrigating techniques. [2015]

3. India 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. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

A comparison between two negative pressure irrigation techniques in simulated immature tooth: an ex vivo study. [2018]

5. United States 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. [2013]

6. Germany pubmed.ncbi.nlm.nih.gov

Tissue response to root canal irrigation systems in dogs' teeth with apical periodontitis. [2021]

7. United States 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. [2019]