RCT vs Pulpotomy for Toothache

Overseen By Sheila Turner, DDS

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Must not be taking: Antidepressants, Methotrexate, Corticosteroids, others

Disqualifiers: Pulp necrosis, Apical periodontitis, Immunosuppressive agents, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

138 Participants Needed

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.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, such as centrally acting drugs (like tricyclic antidepressants) and medications that affect the host response (like methotrexate, corticosteroids, or cyclosporin), as well as immunosuppressive agents. If you are on these medications, you may not be eligible to participate.

What data supports the effectiveness of the treatment RCT, VPT, Virtual Physical Therapy, Telephysical Therapy, Online Physical Therapy for toothache?

Research shows that full pulpotomy (FP), a type of vital pulp treatment (VPT), can be a successful and satisfying alternative to root canal treatment (RCT) for managing toothache due to irreversible pulpitis, with a high success rate and patient satisfaction in public healthcare settings. ^{1 2 3 4 5}

Is vital pulp therapy (VPT) safe for treating toothache?

Vital pulp therapy (VPT) is generally considered safe for treating toothache in mature permanent teeth, as it aims to preserve healthy pulp tissue using minimally invasive methods. ^{1 2 4 6 7}

How does the treatment VPT differ from other treatments for toothache?

Vital pulp therapy (VPT) is a minimally invasive treatment that aims to preserve the health of the tooth's pulp (the innermost part of the tooth) using techniques like indirect and direct pulp capping, and pulpotomy, which are less invasive than traditional root canal therapy (RCT). VPT uses bioactive materials like calcium-enriched mixture cement to promote healing and maintain the vitality of the tooth, offering a more conservative approach compared to the complete removal of pulp tissue in RCT. ^{2 4 7 8 9}

Research Team

Ashraf Fouad, DDS

Principal Investigator

University of Alabama at Birmingham

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.

Tooth is responsive to cold and electrical pulp testing, with or without hyperalgesia

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

Exclusion Criteria

Patients who know that they are or may be pregnant at time of treatment. At the 2-year follow up, if they are pregnant the CBCT will be delayed until they have their baby

I have teeth with crowns covering them completely.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either root canal treatment or pulpotomy

1 day

1 visit (in-person)

Follow-up

Participants are monitored clinically and radiographically for treatment success

2 years

Regular visits (in-person)

Treatment Details

Interventions

• RCT
• VPT

Trial Overview 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.

Participant Groups

Group I: Pulpotomy Experimental Treatment 1 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 Control 1 Intervention

For cases with this diagnosis RCT is the standard of care and will be done according to clinically approved protocols

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Vital pulp treatment for traumatized permanent teeth: A systematic review. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Treatment Outcomes of 4 Vital Pulp Therapies in Mature Molars. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Outcomes reporting in systematic reviews on vital pulp treatment: A scoping review for the development of a core outcome set. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Primary Tooth Vital Pulp Therapy: A Systematic Review and Meta-analysis. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

A Pilot Feasibility Study to Establish Full Pulpotomy in Mature Permanent Teeth with Symptomatic Irreversible Pulpitis as a Routine Treatment in Mexican Public Healthcare Services. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Dentist-related factors influencing the use of vital pulp therapy: a survey among dental practitioners in China. [2020]

7. China pubmed.ncbi.nlm.nih.gov

[Research progress in vital pulp therapy in mature permanent teeth with carious pulp exposure]. [2022]

8. Iran pubmed.ncbi.nlm.nih.gov

Outcomes of different vital pulp therapy techniques on symptomatic permanent teeth: a case series. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Clinical Trial of Pulpotomy versus Root Canal Therapy in Mature Teeth with Irreversible Pulpitis: Outcome, Quality of Life, and Patients' Satisfaction. [2023]