Effectiveness of GentleWave System in Endodontic Treatment

NCT ID: NCT06518304

Last Updated: 2024-08-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-20
• Study Completion Date: 2024-09-20

Brief Summary

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.

Detailed Description

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.

Conditions

Pain, Postoperative; Root Canal Infection; Endodontically Treated Teeth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

GentleWave

Featuring a handpiece CleanFlow technology, optimizes the delivery of irrigants: initially, a 3% NaOCl solution for 3 or 5 minutes, followed by a water rinse for 15 or 30 seconds, an 8% EDTA solution for 2 minutes, and a final distilled water rinse for 15 or 30 seconds. These solutions penetrate and eliminate necrotic tissue, debris, biofilm and bacteria, leaving the dentin intact and preserving the tooth structure. Use of the Gentlewave system is contraindicated in teeth with immature apices, teeth with insufficient coronal structure, and teeth with root apices that extend into the maxillary sinus.

Group Type: OTHER

GentleWave

Intervention Type: 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

Control group

Conventional Syringe Irrigation (CSI), which delivers irrigants (NaOCl, EDTA) through a needle-syringe system. After local anesthesia, the tooth will be isolated with a rubber dam. The pulp chamber will be accessed using ultrasound, eliminating all cavities, restorations with microfiltration or creating access through metal crowns. All canals will be cleaned and shaped with rotary files until at least a canal size of 20.6 or 25.04 is achieved within 0.5 to 1 mm of the apical end. Between each file, 6% NaOCl will be used to disinfect and clean the waste channels. Each canal will then be soaked in 17% EDTA for 1 minute, rinsed with 6% NaOCl, and finally subjected to a final saline rinse. The canals will be filled with root canal sealant and gutta-percha.

Group Type: OTHER

Conventional Protocol

Intervention Type: 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.

Interventions

GentleWave

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

Intervention Type: OTHER

Conventional Protocol

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Salamanca

OTHER

Sponsor Role: lead

Responsible Party

Heilyn Nils

Author- Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

City Endodontics

Manhattan, New York, United States

Countries

United States

Other Identifiers

U1111-1310-8953

Identifier Type: -

Identifier Source: org_study_id