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Procedure
Irrigation Techniques for Postoperative Pain
N/A
Recruiting
Research Sponsored by Cleveland Dental Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Males and females aged 20-50 with mandibular mature first molars with symptomatic acute pulpitis
Be between 18 and 65 years old
Must not have
Periodontal disease
Pulp necrosis or apical periodontitis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 hours, 12 hours, 24 hours,48 hours and 72 hour post-procedure.
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to compare the levels of pain after root canal treatment using different irrigation techniques. The study will include 84 individuals undergoing the same procedure and will assess pain levels at specific time intervals using a
Who is the study for?
This trial is for at least 84 individuals experiencing pain who require root canal therapy. Participants should be suitable for the same endodontic procedure but cannot have conditions that would exclude them from using any of the irrigation methods being tested.
What is being tested?
The study compares four different techniques to manage pain after a root canal: traditional irrigation, ultrasonic, apical negative pressure, and a new method called iVac. Pain levels will be measured using a numerical scale at various times post-treatment.
What are the potential side effects?
While specific side effects are not detailed here, typical ones related to root canal treatments may include temporary discomfort or swelling in the treated area.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 20-50 years old with a painful tooth due to nerve inflammation.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have gum disease.
Select...
I have a dead tooth or root infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 hours, 12 hours, 24 hours,48 hours and 72 hour post-procedure.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 hours, 12 hours, 24 hours,48 hours and 72 hour post-procedure.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Numerical Pain Scale (NRS)
Secondary study objectives
Analgesics intake
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Irrigant activation with negative pressureExperimental Treatment1 Intervention
Final irrigant activation will be performed with apical negative pressure
Group II: Irrigant activation with both Ultrasonic and negative pressureExperimental Treatment1 Intervention
Final irrigation with a combination of ultrasonic and apical negative pressure using the IVAC device.
Group III: Irrigant activation with UltrasonicExperimental Treatment1 Intervention
Final irrigant activation will be done by ultrasonic
Group IV: Conventional root canal treatmentActive Control1 Intervention
Irrigation will be performed with side vented needles only
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ultrasonic
2011
N/A
~140
Find a Location
Who is running the clinical trial?
Cleveland Dental InstituteLead Sponsor
5 Previous Clinical Trials
358 Total Patients Enrolled
2 Trials studying Pain
208 Patients Enrolled for Pain
Ahmed A Hashem, PhDStudy ChairCleveland Dental Institute
1 Previous Clinical Trials
80 Total Patients Enrolled
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