Comparison of Clinical Outcomes Between GentleWave® and Biolase®

NCT05555043 | Completed DMC FDA Device

• 1 other identifier: 21-2960
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: In the US, 15 million root canal treatments (RCTs) are carried out annually. Success rates decrease with conventional chemo-mechanical root canal preparation techniques used on teeth with periapical radiolucencies associated with bacterial presence. New irrigation modalities, such as the GentleWave® System (GWS) and Waterlase iPlus® (WL), have been developed to overcome limitations and improve RCT success rates. Hypotheses: (1) GWS and WL provide superior clinical outcomes compared to conventional RCT using passive ultrasonic activation (PUI). (2) GWS and WL are acceptable treatment modalities for clinicians and patients. Aims: (1) Estimate probability of success of GWS, WL, and conventional RCT with PUI. (2) Evaluate clinician and patient experiences of the different techniques.

Conditions

Endodontic Disease; Periapical Diseases; Periapical Periodontitis; Root Canal Infection

Outcome Measures

Primary Outcomes (1)

• Periapical index score

  A combination of the clinical findings and Periapical Index Scores (PAI) score will be used to determine the primary outcome measure as healed, healing, or diseased as per the following descriptions: (i) Healed: Clinical normalcy other than tenderness to percussion accompanied by PAI scores of 1 or 2 (ii) Healing: Clinical normalcy other than tenderness to percussion accompanied by a reduction in the size of the periradicular lesion denoted by a reduction in the PAI score (iii) Diseased: The presence of clinical signs and symptoms accompanied by a PAI score of 3 or higher or an increase in the PAI score This is a scale of 1-5, where generally a higher number means poorer healing.

  12 months

Secondary Outcomes (1)

• Qualitative data from patient and provider questionnaires about treatment procedure

  from time of treatment completion to 12-month follow-up appointment, assessed up to 12 months

Study Arms (3)

Control group

ACTIVE COMPARATOR

Participants receive passive ultrasonic irrigation for endodontic irrigation treatment and will be followed for 12 months after treatment to assess radiographic healing of the periapex and clinical healing of the tooth.

Device: Irrisafe ip

GentleWave group

EXPERIMENTAL

Participants receive GentleWave System for endodontic irrigation treatment and will be followed for 12 months after treatment to assess radiographic healing of the periapex and clinical healing of the tooth.

Device: GentleWave System

Waterlase group

EXPERIMENTAL

Participants receive Waterlase iPlus for endodontic irrigation treatment and will be followed for 12 months after treatment to assess radiographic healing of the periapex and clinical healing of the tooth.

Device: Waterlase iPlus

Interventions

Irrisafe ip DEVICE

This portion of endodontic treatment includes chemical disinfection of the root canal system with these different devices that activate the disinfection solution and distribute it throughout the root canal system with ultrasonic energy.

Also known as: Passive ultrasonic irrigation

Control group

GentleWave System DEVICE

Prepare, clean and irrigate root canals including activation of the disinfection solution and distribution throughout the root canal system.

Also known as: Sonic cleaning and irrigation

GentleWave group

Waterlase iPlus DEVICE

Prepare tooth and root canal, including enlargement, to debride, clean and disinfect after endodontic treatment.

Also known as: Powered Laser Surgical Instrument

Waterlase group

Eligibility Criteria

• Age: 14 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients 14 years of age or older (maximum of 99 years of age)
• o Participants 14 years of age or older are expected to have permanent teeth erupted in full permanent dentition with close apices
• The subject tooth is indicated for root canal treatment
• One tooth indicated per participant
• Permanent tooth requiring root canal treatment which are deemed restorable
• Teeth exhibiting pulpal pathosis (irreversible pulpitis, pulpal necrosis, previously initiated root canal treatment) and apical periodontitis (with radiographic demonstration of periapical bone loss)
• Patient-signed informed consent/assent form
• Patients display good compliance o Patient is determined cooperative by provider during initial exam and radiographic acquisition

You may not qualify if:

• Patients allergic to local or topical anesthetics, heart disease (pacemakers, implantable defibrillators), lung disease, bleeding disorders, immune system deficiency
• Subject tooth is not clinically restorable (prosthetically or periodontally)
• Mobility scores greater than or equal to 2
• Periodontal pocket depths greater than or equal to 6mm
• Cracks with radicular extension, vertical root fracture or horizontal - oblique fracture
• Subject tooth with open or incomplete apices (apical diameter greater than 1mm)
• Subject tooth has insufficient tooth structure to create GWS platform
• Subject tooth has external cervical root resorption
• Subject tooth has signs of dens invaginatus
• Subject tooth has signs of a palatogingival groove
• Subject tooth has root(s) which communicate with the maxillary antrum
• Patient has nonodontogenic facial pain
• Patient requires multiple teeth to be endodontically treated

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

Univeristy of North Carolina Adams School of Dentistry

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Dental Pulp Diseases; Periapical Diseases; Periapical Periodontitis

Interventions

Therapeutic Irrigation

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Jaw Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Intervention Hierarchy (Ancestors)

Hydrotherapy; Physical Therapy Modalities; Therapeutics; Rehabilitation; Investigative Techniques

Study Officials

• Glenn Karunanayake, BDS, MS

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This is a single blinded study. Following randomization, the participant and treating clinician will not be blinded from the treatment. Reviewers of all data collected will be blinded to the treatment modality provided.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In this block-randomized, single-blinded, randomized control trial, 120 participants will be recruited with 40 participants allocated to the GentleWave System treatment group, 40 participants allocated to the Waterlase treatment group, and 40 participants allocated to a control group receiving commonly used passive ultrasonic irrigation treatment.

Study Record Dates

• First Submitted: September 19, 2022
• First Posted: September 26, 2022
• Study Start: November 8, 2022
• Primary Completion: July 25, 2025
• Study Completion: July 25, 2025
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication.
• Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations

US (1)