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NCT Number: NCT06518304

Effectiveness of GentleWave System in Endodontic Treatment

This study aims to evaluate the efficacy of the GentleWave® System compared to conventional methods in reducing postoperative pain in patients with necrotic pulp or requiring endodontic retreatment.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

City Endodontics

Manhattan, New York, 10016, United States

About this study

New irrigation modalities such as the GentleWave® System, which integrates advanced multisonic ultrasound technology, have been developed to overcome limitations and improve root canal treatments success rates, by ensuring comprehensive cleaning while minimizing mechanical instrumentation. This system, featuring CleanFlow technology, optimizes the delivery of irrigants and promotes efficient root canal debridement. Postoperative pain is common, usually peaking within the first 24 hours after treatment and decreasing thereafter.

In the presence of necrosis, microorganisms can colonize anatomical complexities, such as isthmuses, ramifications and dentinal tubules causing symptoms such as pain, inflammation, and in some cases even odontogenic sinusitis. Conventional Syringe Irrigation (CSI), which delivers irrigants (NaOCl, EDTA) through a needle-syringe system, often fails to reach the entire working length and the intricate anatomy of the root canal. This inadequacy can result in residual bacteria and necrotic tissue, potentially compromising treatment efficacy and increasing the risk of treatment failure; furthermore, positive pressure exerted during CSI may cause the extrusion of irrigants beyond the apex, leading to complications.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female patients from 18 years age or older (maximum of 80 years of age), both genders.
  • The patients in need of an endodontic intervention.
  • All dental groups in both arches were eligible.
  • Patients who do or do not experience symptoms after the endodontic intervention.
  • Patient-signed informed consent/assent form

Exclusion criteria

  • Patients< 18 years old.
  • fractured teeth.
  • Patients who were recommended extraction after the endodontic evaluation.

Treatment and study plan

GentleWave

Other

GentleWave System employs a degassing process that removes dissolved gases from the solution. This optimization prevents the vapor-lock effect and ensures effective energy transmission through the root canal. As the solution enters the pulp chamber, hydrodynamic cavitation occurs, creating microbubbles that implode and generate sound waves across a broad frequency spectrum

Conventional protocol

Other

Delivers irrigants (NaOCl, EDTA) through a needle-syringe system, often fails to reach the entire working length. This inadequacy can result in residual bacteria and necrotic tissue, potentially compromising treatment efficacy and increasing the risk of treatment failure.

Primary outcomes

  1. To evaluate whether using the Gentlewave system demonstrates a significant reduction in the level of postoperative pain after endodontic treatment measured by the VAS (Visual Analog Scale).

    Time frame: 24 hours

    Pain measurements were made using a VAS (Visual Analog Scale of 0-10. Where the value of 0 represented absence of pain and value 10 represented the greatest intensity of pain.

Sponsors and collaborators

Lead sponsor

University of Salamanca

Other

Registry information

Official study title

Randomized Controlled Trial: Effectiveness of GentleWave System in Endodontic Treatment and Its Impact on Reducing Post- Operative Pain.

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 24, 2024
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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