Comparative Effectiveness in the Management of Irreversible Pulpitis

Launched by UNIVERSITY OF ALABAMA AT BIRMINGHAM · Jun 4, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a dental procedure called pulpotomy, which is used to treat a painful condition known as irreversible pulpitis. This condition occurs when the nerves inside a tooth become inflamed and cause severe pain. The trial aims to determine if pulpotomy is an effective treatment for patients with symptomatic irreversible pulpitis and normal surrounding tissues. Researchers will also look for specific signs or markers that might help predict whether the treatment will be successful.

To participate in this trial, individuals must be at least 12 years old and have certain types of molars that show symptoms of irreversible pulpitis but do not have severe damage or infection. Participants will undergo the pulpotomy procedure and then be monitored to see how well it works. It’s important to note that those with more complex dental issues, such as severe decay or infections, will not be eligible for this trial. This study is not yet recruiting participants, but it is designed to help improve dental treatments for those suffering from tooth pain caused by irreversible pulpitis.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.