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Can sonic and laser devices revolutionize root canal healing?

NCT ID NCT05555043

Disease control Sponsor: University of North Carolina, Chapel Hill Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time

Summary

This trial tests whether two newer root canal cleaning devices—GentleWave and Waterlase—can improve healing compared to the standard ultrasonic method. About 120 people needing a root canal will be randomly assigned to one of the three techniques. The study tracks how well the infection clears and how patients feel about the procedure.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
GentleWave System and Waterlase iPlus devices for root canal irrigation
What this could lead to
If successful, these devices could become standard for root canals, potentially improving healing rates and reducing the need for retreatment.
What could go wrong
The trial is relatively small and early, and results may not apply to all cases. There is also a risk that the new devices may not outperform standard care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

120 people

The number who actually took part.

Started

Nov 2022

Finished

Jul 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

14 to 99 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

dental abscess dental pulp disorder Periapical Diseases periapical periodontitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Endodontic disease Periapical diseases Periapical periodontitis Root canal infection

Contacts and locations

Locations

  • Univeristy of North Carolina Adams School of Dentistry

    Chapel Hill, North Carolina, 27599, United States

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