Your session is about to expire
← Back to Search
Multisonic Energy System
GentleWave System for Apical Periodontitis
N/A
Waitlist Available
Led By Fabricio Teixeira, DDS,MS,PhD
Research Sponsored by University of Iowa
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18+ years
Cone-beam computed tomography (CBCT) confirms apical periodontitis at the first visit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline; 6-months; 12 months
Awards & highlights
Study Summary
This trial will study a new root canal treatment to see if it is effective and causes less pain than current methods.
Who is the study for?
This trial is for adults over 18 who can read and speak English, have specific types of molars with a diagnosis of pulp necrosis and apical periodontitis, and can attend follow-ups. It's not for those with untreated gum disease, poor dental visit attendance, or students/trainees linked to the research team.Check my eligibility
What is being tested?
The study tests the GentleWave System in root canal treatments over a year. It focuses on pain after surgery, patient satisfaction, and how well the treatment heals infected root canals compared to traditional methods.See study design
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects may include discomfort or pain during or after the procedure, swelling around treated areas, temporary numbness due to anesthesia used during treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My dental scan shows I have root tip inflammation.
Select...
My tooth's nerve is dead and has a painless infection at the root.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline; 6-months; 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline; 6-months; 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from Day 2 of research subject's thoughts on treatment result across 1 year.
Change from baseline of Cone Beam Computed Tomography Periapical Index (CBCTPAI) across 1 year
Change from baseline of modified wound healing scale (Mod-CWHS) across 1 year
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Sonendo GentleWaveExperimental Treatment1 Intervention
Every participant will receive the same experimental treatment, which is root canal therapy using the Sonendo GentleWave System.
Find a Location
Who is running the clinical trial?
University of IowaLead Sponsor
446 Previous Clinical Trials
879,422 Total Patients Enrolled
Fabricio Teixeira, DDS,MS,PhDPrincipal InvestigatorUniversity of Iowa College of Dentistry
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My tooth has had previous treatment like cleaning out the pulp.I experience facial pain not related to my teeth.I am currently taking corticosteroids.I am 18 years old or older.My tooth is very loose.My tooth problem is with a lower back molar.My dental scan shows I have root tip inflammation.I can attend follow-up visits 6 months and 1 year after starting treatment.I work under the Principal Investigator or am part of the research team.My tooth's nerve is dead and has a painless infection at the root.My tooth is alive and not dead.I have severe gum disease that hasn't been treated or had recent gum surgery.I am a student or trainee working under the research team's guidance.I have severe gum disease that hasn't been treated or had recent gum surgery.My tooth is being eroded from inside or outside.My tooth is cracked or visibly fractured.I have a tooth with fillings that need to be redone or cavities.My tooth with an unfinished root has a type of infection at its tip.
Research Study Groups:
This trial has the following groups:- Group 1: Sonendo GentleWave
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what criteria must participants adhere to in order to be accepted for this trial?
"The purpose of this clinical trial is to evaluate the efficacy of a new intervention for apical periodontitis. An estimated 80 participants are needed, aged 18 or older and having at least one molar as their affected tooth. Furthermore, all enrollees must be available for follow-up visits after 6 months and 1 year from baseline treatment."
Answered by AI
Are there any vacant slots for participants in this trial?
"The clinicaltrials.gov portal indicates that this trial has ceased recruitment efforts, with its initial listing posted on August 27th 2021 and the last update made to it occurring in September 24th 2022. Nevertheless, there are currently 86 other studies actively seeking participants."
Answered by AI
Does age requirement restrict participation in this research trial for individuals above 75 years old?
"This clinical study is searching for participants that are 18 or older but younger than 99 years of age."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger