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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two dental procedures to determine which is more effective for treating toothaches caused by symptomatic irreversible pulpitis (a painful inflammation inside the tooth). One group will receive the standard root canal treatment (RCT), while the other will undergo an experimental procedure called pulpotomy, which involves partially removing the inflamed tissue. Researchers aim to identify clinical and molecular markers (indicators in the body) that predict the effectiveness of pulpotomy. Individuals experiencing toothaches with spontaneous pain and sensitivity to cold for more than 30 seconds, but without damaged tooth roots, might be suitable candidates. As an unphased trial, this study allows patients to contribute to dental research and potentially benefit from innovative treatment options.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that pulpotomy is safe. One study reported a 94.4% success rate for pulpotomies, considered excellent. Another study found that using Biodentine® for pulpotomy achieved a survival rate of 96.3% over 18 months and 95.4% over 24 months. These results suggest that pulpotomy is well-tolerated and effective.

Root canal treatment (RCT) is the standard care for the condition under study, having been proven safe and effective in many cases. Although the current trial does not provide new safety data, the established use of RCT reassures its safety.

Overall, both treatments in the trial have demonstrated good safety records in previous studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about pulpotomy with tricalcium silicates because it offers a potentially less invasive alternative to traditional root canal treatment (RCT) for managing toothache. Unlike RCT, which involves removing the entire pulp of the tooth, pulpotomy focuses on removing only part of the pulp and then sealing the area with tricalcium silicates. This approach could preserve more of the natural tooth structure and lead to quicker recovery times. Additionally, tricalcium silicates have shown high clinical success, suggesting that pulpotomy could be just as effective, if not more, in certain cases. This trial aims to compare its effectiveness directly with RCT, which is the current standard of care.

What evidence suggests that this trial's treatments could be effective for toothache?

Research has shown that pulpotomy, a dental procedure that removes part of the tooth's inner tissue, effectively treats toothaches caused by severe inflammation. One study reported a 93.3% success rate for pulpotomy after 6 months, which increased to 96.2% after 1 year. Another study found that using special cements in pulpotomy matched the effectiveness of root canal treatment (RCT) for decayed teeth. This trial will compare pulpotomy, which participants may receive, with RCT, the standard of care in another arm, to determine their effectiveness under similar conditions. These findings suggest that pulpotomy can be a strong alternative to traditional RCT for certain dental problems. ^{2 6 7 8 9}

Who Is on the Research Team?

Ashraf Fouad, DDS

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12425402/

Clinical and Radiographic Outcomes Following Pulpotomy ... The overall success rate was 93.3% at 6 months (Biodentine: 93.1%, MTA: 93.5%), escalating to 96.2% at 1 year and 100% at 2 years. The success ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8836521/

Short-Term Pain Evolution and Treatment Success of ... Short-term pain evolution and treatment success of pulpotomy as irreversible pulpitis permanent treatment: a non-randomized clinical study.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0300571224005621

Effectiveness of pulpotomy in managing carious exposure ... Pulpotomy with bioactive hydraulic calcium silicate cements shows comparable success rates to RCT in managing carious pulp exposure in mature permanent teeth.

4. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06802549

Outcomes of Partial Pulpotomy Treatment in Cariously ... The aim of this clinical trial is to learn how successful Biodentine and Theracal PT dental filling materials are in treating deep tooth decay in adults. It ...

5. journals.lww.com journals.lww.com/senj/fulltext/2024/14030/outcomes_of_pulpotomy_using_calcium_silicates_in.1.aspx

Outcomes of pulpotomy using calcium silicates in ... Furthermore, the success rate was found to be 83.8% after 4 years of follow-up, with only 10 of the total cases experiencing endodontic failure. Thus, the ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10844323/

Randomized clinical trial of pulpotomy using a premixed ... The study reported an overall success rate of 94.4%, which is considered excellent for pulpotomies. The success rate was assessed based on ...

7. aapd.org aapd.org/globalassets/media/policies_guidelines/g_vpt-2024.pdf

Use of Vital Pulp Therapies in Primary Teeth 2024 IPT and calcium silicate cement pulpotomy were both effective treatments for relieving pre-operative reversible pulpitis pain in teeth. This type of pain is ...

8. mdpi.com mdpi.com/2077-0383/11/3/787

Short-Term Pain Evolution and Treatment Success of ... The objective of this work was to evaluate (1) the short-term evolution of pain and (2) the treatment success of full pulpotomy as permanent treatment of ...

9. jocpd.com jocpd.com/articles/10.22514/jocpd.2024.011/htm

Biodentine as a pulpotomy medicament for primary molars The survival probablity of using Biodentine® as a pulpotomy medicament is 96.3% for 18-month follow-up and 95.4% for 24-month follow-up.