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Procedure

GentleWave vs. Waterlase for Root Canal Treatment

N/A

Waitlist Available

Led By Glenn Karunanayake, BDS, MS

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study Summary

This trial compared the success rates of three different root canal treatments: the GentleWave System, Waterlase iPlus, and conventional root canal treatment using passive ultrasonic activation. They also looked at clinician and patient experiences with the different techniques. They found that the GentleWave System and Waterlase iPlus had higher success rates than the conventional root canal treatment, and that both were acceptable to clinicians and patients.

Who is the study for?

This trial is for males and females aged 14-99 with a permanent tooth needing root canal treatment due to pulp disease or infection, who can consent to the procedure. It's not for those with teeth that can't be restored, have high mobility or deep periodontal pockets, fractures, open apices, certain anatomical challenges, need multiple RCTs, allergies to anesthetics or severe systemic diseases.Check my eligibility

What is being tested?

The study compares new root canal irrigation methods: GentleWave System (GWS) and Waterlase iPlus (WL), against conventional passive ultrasonic activation (PUI). It aims to see which method gives better results and how patients and clinicians feel about them.See study design

What are the potential side effects?

While specific side effects are not listed here, typical risks of root canal treatments include discomfort during/after the procedure, swelling in treated area, potential damage to surrounding teeth/gums from equipment use.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

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

Screening ~ 3 weeks

Treatment ~ Varies

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and from time of treatment completion to 12-month follow-up appointment, assessed up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Periapical index score

Secondary outcome measures

Qualitative data from patient and provider questionnaires about treatment procedure

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Waterlase groupExperimental Treatment1 Intervention

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.

Group II: GentleWave groupExperimental Treatment1 Intervention

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.

Group III: Control groupActive Control1 Intervention

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor

1,504 Previous Clinical Trials

4,187,542 Total Patients Enrolled

Glenn Karunanayake, BDS, MSPrincipal InvestigatorUniversity of North Carolina, Chapel Hill

Media Library

GentleWave System (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05555043 — N/A

Root Canal Research Study Groups: Waterlase group, Control group, GentleWave group

Root Canal Clinical Trial 2023: GentleWave System Highlights & Side Effects. Trial Name: NCT05555043 — N/A

GentleWave System (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05555043 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the trial include minors under 20 years of age?

"This trial is recruiting patients aged 14 or above, up to 99 years of age."

Answered by AI

Are there any qualifications needed to participate in this experimental program?

"This medical trial is currently recruiting 120 individuals, between the ages of 14 and 99 with periapical diseases. To qualify for this study, potential participants must meet each of the following criteria: one tooth indicated per person; show good compliance and be deemed cooperative by their provider during the initial exam; male or female patients aged 14 years old or older (maximum age 99); have permanent teeth erupted in full permanent dentition with close apices; require root canal treatment which are deemed restorable; exhibit pulpal pathosis (e.g., irreversible pulpitis, pulpal necrosis) and/or apical periodontitis evidenced through"

Answered by AI

Does this experiment currently have any open slots for participants?

"As per the clinicaltrials.gov website, this trial is no longer accepting applicants. The project was initially advertised on October 13th 2022 and its most recent update was September 22nd 2022. Although not actively seeking participants, there are 100 other trials currently open for enrollment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Comparison of Clinical Outcomes Between GentleWave® and Biolase®

2022. "Comparison of Clinical Outcomes Between GentleWave® and Biolase®". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05555043.