What side effects are associated with this type of intervention?

Pulpotomy, a procedure involving the removal of the coronal portion of the dental pulp to preserve the vitality of the remaining pulp tissue, is generally well-tolerated. However, potential side effects can include postoperative pain, sensitivity, and, in some cases, infection if the procedure is not performed under sterile conditions. Other common treatments for toothache, such as root canal therapy, may also lead to similar side effects, including discomfort, swelling, and, rarely, damage to surrounding tissues.

What prior FDA approvals exist?

The FDA has approved various treatments for toothache, particularly those involving dental procedures like pulpotomy. Pulpotomy is a common procedure for treating symptomatic irreversible pulpitis, aiming to preserve the vitality of the remaining pulp tissue. While specific FDA-approved drugs for pulpotomy are not detailed, the procedure often involves the use of medicaments such as formocresol, ferric sulfate, or mineral trioxide aggregate (MTA) to disinfect and protect the pulp. These agents help in maintaining the health of the remaining pulp tissue and are integral to the success of the pulpotomy procedure.

What other types of research exist?

Promising, novel alternatives to pulpotomy for toothache patients in 2024 include regenerative endodontic procedures (REPs) and vital pulp therapy (VPT) using bioactive materials. REPs involve the use of stem cells, growth factors, and scaffolds to regenerate damaged pulp tissue. VPT with bioactive materials, such as calcium silicate-based cements (e.g., Biodentine, MTA), aims to promote healing and maintain pulp vitality by creating a protective barrier and stimulating tissue regeneration.

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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

Must not have

Teeth with full coverage crowns

Patients who require IV sedation or general anesthesia for their dental treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to 2 years

Awards & highlights

Summary

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.

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.

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.

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 below

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have teeth with crowns covering them completely.

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I need to be sedated or put under general anesthesia for dental work.

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I have swelling or a draining wound.

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I do not have the opposite side molar teeth.

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My teeth are severely damaged and cannot be fixed.

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If my tooth needs more anesthesia during a pulpotomy, it's considered a failure and will need root canal treatment.

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I need a root canal for dental restoration purposes.

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I am on immunosuppressants or have an autoimmune disease.

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My tooth did not stop bleeding after treatment and requires a root canal.

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I am not taking medications like methotrexate, corticosteroids, or cyclosporin.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline through 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of patients with a successful outcome of pulpotomy versus RCT

Secondary study objectives

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

~370

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Pulpotomy involves the removal of the coronal portion of the dental pulp to preserve the vitality of the remaining pulp tissue. This procedure is effective in treating symptomatic irreversible pulpitis by eliminating the inflamed pulp tissue, thereby reducing pain and preventing the spread of infection. Other common treatments for toothache include root canal therapy, which removes all pulp tissue and seals the tooth to prevent reinfection, and simple analgesics like NSAIDs or acetaminophen, which reduce inflammation and alleviate pain. Understanding these mechanisms helps patients make informed decisions about their treatment options and manage their pain effectively.

What is the best effective postoperative medication in reducing pain after non-surgical root canal treatment?The treatment modalities of masticatory muscle pain a network meta-analysis.Postoperative pain following the use of two different intracanal medications.