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Procedure

GentleWave for Tooth Pulp Necrosis

N/A
Waitlist Available
Led By David Jaramillo, DDS
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Permanent teeth that are diagnosed with pulp necrosis.
* elected to have a permanent tooth nonsurgical root canal treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, after cleaning and shaping of the root canal (about 30 minutes after baseline)
Awards & highlights

Summary

The purpose of this study is to compare the efficacy of GentleWave versus EdgePro irrigation in the disinfection of infected root canals of human permanent teeth with necrotic pulp.

Who is the study for?
This trial is for individuals with dead tooth pulp in their permanent teeth, which often leads to infection. Participants should have this condition in at least one lower molar.
What is being tested?
The study aims to compare the effectiveness of two different cleaning systems, GentleWave and EdgePro laser irrigation, used during root canal treatments on infected molars with dead pulp tissue.
What are the potential side effects?
While specific side effects are not listed, typical risks may include discomfort or pain during or after the procedure, temporary swelling or bleeding, and a chance of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, after cleaning and shaping of the root canal (about 30 minutes after baseline)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, after cleaning and shaping of the root canal (about 30 minutes after baseline) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Bacterial count reduction checked by 16 S rDNA next-generation sequencing analysis (NGS)
Secondary study objectives
Presence of proteolytic versus non-proteolytic bacteria in the root canals

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: GentleWaveExperimental Treatment1 Intervention
Group II: EdgeProExperimental Treatment1 Intervention
Group III: Irrisafe passive ultrasonic irrigationActive Control1 Intervention

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
926 Previous Clinical Trials
333,491 Total Patients Enrolled
David Jaramillo, DDSPrincipal InvestigatorThe University of Texas Health Science Center, Houston
~20 spots leftby May 2025
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