Comparative Effectiveness in the Management of Irreversible Pulpitis (NCT04922229) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Comparative Effectiveness in the Management of Irreversible Pulpitis
United States138 participantsStarted 2027-06-01
Plain-language summary
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.
Who can participate
Age range12 Years – 99 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Percentage of patients with a successful outcome of pulpotomy versus RCT