Comparative Effectiveness in the Management of Irreversible Pulpitis

Study Overview
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Brief Summary
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This project addresses a central question within the practice of dentistry: What is the optimal treatment of carious pulp exposure, in a tooth with a vital pulp and normal periapex. In addition, the project seeks to identify clinical and laboratory findings that would be predictive of success of vital pulp therapy.

Detailed Description
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In this study, 138 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.

Official Title
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Comparative Effectiveness in the Management of Irreversible Pulpitis

Conditions
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Irreversible Pulpitis

Intervention / Treatment
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* Procedure: RCT
* Procedure: Pulpotomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Maxillary or mandibular first or second mature permanent molars with carious lesions or restorations (excluding crowns), with signs and symptoms of reversible or irreversible pulpitis, requiring treatment, where pulp exposure is detectable upon excavation. Tooth is responsive to cold and electrical pulp testing, with or without hyperalgesia Patients aged ≥10y for first molars and ≥16y for second molars Exclusion Criteria: Evidence of Pulp Necrosis or Apical Periodontitis, preoperatively or upon inspection of an exposure site Absence of a contralateral molar teeth 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 tooth Teeth with radiographic evidence of internal, or external cervical, inflammatory or replacement root resorption, or with pulp canal obliteration Teeth with no clinical evidence of pulp exposure upon excavation Radiographic evidence of PDL space wider than three times normal width on preoperative CBCT 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 in the pulpotomy group that require intra-pulpal anesthesia for completion of treatment will be considered a treatment failure and treated with RCTx. Teeth that require elective RCTx, regardless of pulpal diagnosis, for restorative purposes. Teeth in the pulpotomy group in which bleeding does not stop after 10 minutes with 3% hypochlorite cotton pellet. These will be considered treatment failure and treated with RCTx. Patients who know that they are or may be pregnant at time of treatment. At the 2-year follow up, if they are pregnant the CBCT will be delayed until they have their baby.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Root canal treatment (RCT)<br>For cases with this diagnosis RCT is the standard of care and will be done according to clinically approved protocols | Procedure: RCT<br>* This is the standard of care for this diagnosis<br>* Other names: Endodontic therapy;|
| Experimental: Pulpotomy<br>Pulpotomy with tricalcium silicates has shown high clinical success in these cases. However, it is not known how this success compares to RCT under similar conditions and with an intent-to-treat study design, which will be employed here. | Procedure: Pulpotomy<br>* For cases with normal apical tissues, pulpotomy using tricalcium silicates has been shown to have high clinical success. Either partial or complete pulpotomy will be performed depending on the size of pulp exposure.<br>* Other names: Therapeutic pulpotomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with a successful outcome of pulpotomy versus RCT | A composite of clinical and radiographic findings and incidence of follow up procedures | From baseline through 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine prognostic validity of preoperative hyperalgesia in determining the outcome of pulpotomy | Neurosensory measurements of preoperative signs and symptoms will be measured and correlated with the outcome of pulpotomy | From baseline to two years | 
| Determine prognostic validity of a set of pulpal inflammatory proteins in determining the outcome of pulpotomy | Protein analysis at the time of treatment will be correlated with the outcome of pulpotomy | From baseline to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vital Pulp Therapy, Pulpotomy