Pulpotomy as a Treatment of Irreversible Pulpitis

Study Overview
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Brief Summary
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The procedure currently recommended for the treatment of irreversible pulpitis is the endodontic treatment, i.e. the complete elimination of the pulp, disinfection and obturation of the whole root canal system. The emergency procedure consists of a pulpotomy, followed at an ulterior appointment by the root canal treatment. The purpose of the present pilot study is to evaluate the feasibility of performing the pulpotomy as a permanent treatment in mature molars. If hemostasis can be achieved after removing the coronal part of the pulp, a tricalcium silicate cement will be directly applied on the remaining pulp at the root canal entrances. A short-term follow-up will be performed at one week by evaluating the pain relief of the patient. Long-term success will then be evaluated every year by verifying the absence of periapical radiolucency on the x-ray as well as the absence of clinical symptoms and signs. A standard root canal procedure will serve as control. During the pulpotomy treatment, blood sample with microcapillary will be performed. We will analyze a ratio of pro-inflammatory and anti-inflammatory cytokines.

Official Title
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Pulpotomy as a Permanent Treatment of Irreversible Pulpitis on Mature Molar Teeth - a Pilot Study

Conditions
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Irreversible Pulpitis

Intervention / Treatment
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* Procedure: Pulpotomy
* Procedure: Endodontic treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Good general health Not pregnant women At least one permanent molar in irreversible pulpitis Adult patient Mentally competent Exclusion Criteria: Periapical radiolucency Periodontical probing Root fracture Sinus tract Swelling or mobility External or/and internal resorption Open apicies A non restorable tooth

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Endodontic treatment<br>The patient will benefit from a conventional treatment : a root canal treatment. The root canal treatment consists of removing the pulp tissue from all the canals, disinfecting the root canal system with sodium hypochlorite and filling the root with a root canal sealer and gutta percha. | Procedure: Endodontic treatment<br> <br> |
| Experimental: Pulpotomy<br>The patient will benefit from an experimental treatment : a pulpotomy. The pulpotomy aims at removing the coronal part of the pulp (the pulp present in the pulp chamber) and filling the pulp chamber with a bioactive material. | Procedure: Pulpotomy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the success rate (%) at 1 year | to evaluate the treatment success defined as the absence of clinical symptoms (pain, sinus tract..) and the absence of radiological symptoms (periapical radiolucency), in order to point the non-inferiority of the pulpotomy compared with the conventional treatment | Follow up at 1 year for all patients included in the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the correlation between pro/anti-inflammatory cytokines and the success of pulpotomy | During the pulpotomy treatment, blood samples with microcapillaries will be performed. We will analyze a ratio of pro-inflammatory and anti-inflammatory cytokines. | Follow up at 1 year for all patients included in the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pulpotomy, pulpitis, mature tooth, tricalcium silicate