Effectiveness of GentleWave System in Endodontic Treatment

NCT06518304 | Not Yet Recruiting

• 1 other identifier: U1111-1310-8953
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative; Root Canal Infection; Endodontically Treated Teeth

Outcome Measures

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.

  24 hours

Study Arms (2)

GentleWave

OTHER

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.

Other: GentleWave

Control group

OTHER

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.

Other: Conventional Protocol

Interventions

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

GentleWave

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.

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Salamanca: lead

Study Sites (1)

City Endodontics

Manhattan, New York, 10016, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Tooth, Nonvital

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Author- Principal Investigator

Study Record Dates

• First Submitted: July 5, 2024
• First Posted: July 24, 2024
• Study Start: August 20, 2024
• Primary Completion: August 20, 2024
• Study Completion: September 20, 2024
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)