Comparative Effectiveness in the Management of Irreversible Pulpitis

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-99
SponsorUniversity of Alabama at Birmingham

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • RCT
  • Pulpotomy

Treatment groups

138 Participants
are divided into 2 treatment groups