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Histological Evaluation in the Efficacy of GentleWave in Root Canal Pulp Tissue Debridement and Disinfection of Difficult to Reach Areas in Mandibular Human Molars II. An In-vivo Study.

ConditionRoot Canal Treatment
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorThe University of Texas Health Science Center, Houston

About this trial

The purpose of this study is to understand and learn better the efficacy of GentleWave and obtain histological evidence of the efficacy of this new technology done in-vivo

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Only teeth that patient decided to have the extraction done instead of having any other type of dental treatment and teeth extracted at patient's petition.

Disqualifiers

Teeth with root fractures or previously root canal treated teeth.

Teeth with severe loss of structure

Children

Trial design

Design model

Single group

Treatments tested in this trial

  • GentleWave

    Device

    Subject teeth will receive a partial root canal treatment with the Sonendo GentleWave system followed by extraction of the tooth and histological evaluation of the tooth

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Partial root canal treatment with the Sonendo GentleWaveExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Visualization of the amount of pulp tissue left behind after GentleWave procedure

Visualization of the amount of pulp tissue left behind after GentleWave procedure as assessed by reviewing the histological serial sections under the light microscope

Time frame
at the time of tooth extraction(immediately after GentleWave procedure)

Secondary outcomes

1

Number of participants with the presence of bacteria inside the root canal and inside the dentinal tubules as assessed by observation under the light microscope

Time frame
at the time of tooth extraction(immediately after GentleWave procedure)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Texas Health Science Center, Houston

Lead sponsor

Sonendo, Inc.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: