Effectiveness of GentleWave System in Endodontic Treatment

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Salamanca

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Patients< 18 years old.

fractured teeth.

Patients who were recommended extraction after the endodontic evaluation.

Trial design

Design model

Parallel

Treatments tested in this trial

  • GentleWave

    Other intervention

    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 intervention

    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.

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: GentleWaveOther 1 intervention
Group B: Control groupOther 1 intervention

Trial outcomes

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).

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.

Time frame
24 hours

Secondary outcomes

Other outcomes

Sponsors and contacts

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