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Procedure
RCT vs Pulpotomy for Toothache
N/A
Waitlist Available
Led By Ashraf Fouad, DDS
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Maxillary or mandibular first or second mature permanent molars with carious lesions or restorations (excluding crowns), with signs and symptoms of reversible or irreversible pulpitis, requiring treatment, where pulp exposure is detectable upon excavation
Patients aged ≥10y for first molars and ≥16y for second molars
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to 2 years
Awards & highlights
Study Summary
This trial is testing different ways to treat a tooth with a cavity that has reached the nerve (pulp). The goal is to find the best way to treat this type of Cavity so that the tooth doesn't need to be removed.
Who is the study for?
This trial is for people with a toothache from a mature permanent molar that's still alive and has caries or fillings, but isn't badly broken or unrestorable. Participants should be over 10 years old for first molars and over 16 for second molars. They can't join if they have certain dental conditions, are on specific medications, pregnant, or need sedation/general anesthesia.Check my eligibility
What is being tested?
The study is testing two treatments to manage irreversible pulpitis in teeth: pulpotomy (removing the diseased part of the pulp) versus root canal therapy (RCT). It aims to find out which treatment works best and what signs predict successful vital pulp therapy.See study design
What are the potential side effects?
Possible side effects include discomfort at the site of treatment, infection risk due to exposure during procedures, temporary sensitivity or pain post-treatment. In some cases where treatment fails, additional interventions like RCT may be necessary.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a deep cavity or filling in my molar that may have reached the nerve, causing pain.
Select...
I am at least 10 years old for first molar treatment and 16 for second.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline through 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline through 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of patients with a successful outcome of pulpotomy versus RCT
Secondary outcome measures
Determine prognostic validity of a set of pulpal inflammatory proteins in determining the outcome of pulpotomy
Determine prognostic validity of preoperative hyperalgesia in determining the outcome of pulpotomy
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: PulpotomyExperimental Treatment1 Intervention
Pulpotomy with tricalcium silicates has shown high clinical success in these cases. However, it is not known how this success compares to RCT under similar conditions and with an intent-to-treat study design, which will be employed here.
Group II: Root canal treatment (RCT)Active Control1 Intervention
For cases with this diagnosis RCT is the standard of care and will be done according to clinically approved protocols
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pulpotomy
2020
N/A
~350
Find a Location
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,583 Previous Clinical Trials
2,279,906 Total Patients Enrolled
2 Trials studying Toothache
1,000 Patients Enrolled for Toothache
Ashraf Fouad, DDSPrincipal InvestigatorUniversity of Alabama at Birmingham
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a deep cavity or filling in my molar that may have reached the nerve, causing pain.I have teeth with crowns covering them completely.I need to be sedated or put under general anesthesia for dental work.I have swelling or a draining wound.I do not have the opposite side molar teeth.I haven't taken any central nervous system affecting pain meds in the last 6 months.My teeth are severely damaged and cannot be fixed.If my tooth needs more anesthesia during a pulpotomy, it's considered a failure and will need root canal treatment.I need a root canal for dental restoration purposes.I am at least 10 years old for first molar treatment and 16 for second.I am on immunosuppressants or have an autoimmune disease.My tooth did not stop bleeding after treatment and requires a root canal.I am not taking medications like methotrexate, corticosteroids, or cyclosporin.
Research Study Groups:
This trial has the following groups:- Group 1: Root canal treatment (RCT)
- Group 2: Pulpotomy
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.
Are there open spots still available in this clinical investigation?
"The information found on clinicaltrials.gov indicates that this medical experiment is not presently taking part in patient recruitment as of now. The study was first launched on December 1st 2023 and last amended February 3rd 2022, though there are currently 21 other studies seeking volunteers at the moment."
Answered by AI
What are the stipulations for participation in this experiment?
"Potential participants for this trial must have pulpitis and range in age from 10 to 99 years. The researchers are actively searching for around 138 enrollees."
Answered by AI
Are individuals over the age of 30 being enrolled in this investigation?
"The requirements for participation in this clinical trial include being aged between 10 to 99 years. For those under 18 or above 65, there are 11 and 8 specific trials respectively."
Answered by AI
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