Effectiveness of GentleWave System in Endodontic Treatment
Randomized Controlled Trial: Effectiveness of GentleWave System in Endodontic Treatment and Its Impact on Reducing Post- Operative Pain.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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Manhattan, New York, United States, 10016
- City Endodontics
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Other: 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.
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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
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Other: 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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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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.
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24 hours
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- U1111-1310-8953
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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