Not yet recruiting NCT04105907
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.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: GentleWave.
- Who it may be relevant to
- Registry conditions: Root Canal Treatment. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Interventions
- Device GentleWave
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
Primary outcome measures
- Visualization of the amount of pulp tissue left behind after GentleWave procedure [Time frame: at the time of tooth extraction(immediately after GentleWave procedure)]
Secondary outcome measures (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)]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- Teeth with root fractures or previously root canal treated teeth.
- Teeth with severe loss of structure
- Children
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- The University of Texas Health Science Center at Houston — Houston
Identifiers
NCT: NCT04105907 · HSC-DB-19-0476