RCT vs Pulpotomy for Toothache

Recruiting in Palo Alto (17 mi)

Overseen ByAshraf Fouad, DDS

Age: Any Age

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Alabama at Birmingham

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial is testing if a pulpotomy, a procedure to remove diseased tooth pulp, is effective for patients with severe toothache but healthy surrounding tissues. The goal is to see if this treatment can relieve pain and prevent further issues. Pulpotomy has been shown to be a successful treatment for managing irreversible pulpitis, challenging the notion that root canal treatment is the only option.

Eligibility Criteria

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.

Inclusion Criteria

I have a deep cavity or filling in my molar that may have reached the nerve, causing pain.

I am at least 10 years old for first molar treatment and 16 for second.

Exclusion Criteria

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.

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 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.

Participant Groups

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.

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