Comparative Effectiveness in the Management of Irreversible Pulpitis

This study is looking at the best way to treat a tooth with "irreversible pulpitis" (a severe toothache where the pulp inside the tooth is inflamed and can't heal on its own). Researchers are comparing two treatments: standard root canal treatment (RCT) and a procedure called pulpotomy. Pulpotomy involves removing only part of the inflamed pulp. You could be eligible if you are between 12 and 99 years old, have a mature permanent molar with irreversible pulpitis, and your tooth responds to cold and electrical tests. The main goal is to see which treatment leads to a successful outcome for more patients over two years. The study aims to enroll 138 participants, but its current recruitment status is unclear.

Study design: This study will randomly assign participants to one of two treatment groups: root canal treatment or pulpotomy. Approximately 138 participants are planned for enrollment.
What's involved: You would receive either a root canal treatment or a pulpotomy. You would then be followed clinically and with X-rays for two years after your treatment.
Compensation: Not stated in the trial record.
Follow-up: Participants will be followed clinically and radiographically for two years after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Comparative Effectiveness in the Management of Irreversible Pulpitis

Not Yet Recruiting

NAAges 12–99InterventionalTreatment

University of Alabama at Birmingham

~138 participants

Updated 2026-02-17 on ClinicalTrials.gov

What's tested:RCTPulpotomy

At a glance

Recruiting sites

0 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Percentage of patients with a successful outcome of pulpotomy versus RCT

Measured over From baseline through 2 years

Conditions

Irreversible Pulpitis

Where it's being run

1 sites across 1 states

Alabama1

Study leadership

Ashraf Fouad, DDS · PRINCIPAL_INVESTIGATOR · University of Alabama at Birmingham

Who to contact

Sheila Turner, DDS

[email protected]

(205) 934-5045

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Maxillary or mandibular first or second mature permanent molars with carious lesions or restorations (excluding crowns), with signs and symptoms of symptomatic irreversible pulpitis (defined as spontaneous pulpal pain and cold hyperalgesia \>30 seconds), and normal apical tissues.

Tooth is responsive to cold and electrical pulp testing.

Patients aged ≥12 years for first molars and ≥16 years for second molars.

Exclusion

Evidence of Pulp Necrosis or Apical Periodontitis, preoperatively or upon inspection of an exposure site

Teeth that are badly broken down and/or are not restorable.

Teeth with mechanical allodynia assessed by registering bite force that is at least 50N lower than the contralateral side.

Teeth with radiographic evidence of internal, or external cervical, inflammatory or replacement root resorption, or with complete pulp canal obliteration.

Radiographic evidence of PDL space wider than three times normal width

Clinical evidence of swelling or sinus tract

Periodontal pocket probing depth ≥5 mm in any site around the tooth.

Clinical evidence of cracks connecting mesial and distal surfaces and/or extending in pulp chamber or associated with periodontal pockets ≥ 5 mm.

History of taking centrally acting drugs (e.g., tricyclic antidepressants), which interfere with the release of pain mediators and/or modify pain experience, within the previous 6 months.

Use of medications that affect the host response such as methotrexate, corticosteroids or cyclosporin.

Patients on immunosuppressive agents, chronic corticosteroid use, autoimmune disease, or other immunocompromising diseases or medications.

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

Teeth with full coverage crowns.

Teeth undergoing active orthodontic movement.

Teeth that require elective RCTx to place a post for restorative purposes.

Teeth with no contralateral molars with normal pulp and periapical tissues for bite and pulp testing controls.

Teeth in the pulpotomy group in which, following complete pulpotomy, bleeding does not stop after 10 minutes with 3-4% hypochlorite cotton pellet. These will be considered treatment failure and treated with RCTx.

What this trial measures

Percentage of patients with a successful outcome of pulpotomy versus RCTFrom baseline through 2 years
A composite of clinical and radiographic findings and incidence of follow up procedures

Trialytics