Comparative Effectiveness in the Management of Irreversible Pulpitis

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Conditions studied: Irreversible Pulpitis

In brief

This project addresses a central question within the practice of dentistry: Is a pulpotomy procedure effective in the treatment of a tooth with symptomatic irreversible pulpitis and normal periapex? In addition, the project seeks to identify clinical and molecular biomarkers that are predictive of the success of pulpotomy.

Key facts

Study ID

NCT04922229

Run by

University of Alabama at Birmingham

People needed

138

Starts

2027-06-01

Expected to finish

2031-12-31

Last updated by the study team

2026-02-17

Who can join

Age: 12 and older, up to 99. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• School of Dentistry, University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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