Clinical trial NCT04922229: Comparative Effectiveness in the Management of Irreversible Pulpitis
Official title: Comparative Effectiveness in the Management of Irreversible Pulpitis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Irreversible Pulpitis
Keywords: Pulpotomy
Vital Pulp Therapy
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2021-06-10
Enrollment: 138
Sex: ALL
Minimum age (years): 12
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: In this study, patients will be randomized to two groups. All patients will have a diagnosis of irreversible pulpitis with normal apical tissues. The groups will be root canal treatment and pulpotomy. The patients will be followed clinically and radiographically for 2 years following the treatment. Predictors of the outcome of pulpotomy will be clinical and laboratory-based parameters.

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.

Primary outcomes:
measure: Percentage of patients with a successful outcome of pulpotomy versus RCT
timeFrame: From baseline through 2 years
Secondary outcomes:
measure: Determine prognostic validity of preoperative hyperalgesia in determining the outcome of pulpotomy
timeFrame: From baseline to two years
measure: Determine prognostic validity of a set of pulpal inflammatory proteins in determining the outcome of pulpotomy
timeFrame: From baseline to 2 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: School of Dentistry, University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Ashraf Fouad, DDS
role: PRINCIPAL_INVESTIGATOR
References: