Clinical Trial: Pulpotomy as a Treatment of Irreversible Pulpitis

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:
Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Current Primary Outcome: Evaluation of the success rate (%) at 1 year by clinical and radiological examination [ Time Frame: Follow up at 1 year for all patients included in the study ]

to evaluate the clinical (pain and functionality of the tooth) and radiological (absence of periapical lesion) success of both of the studie's two arms, in order to point the non-inferiority of the pulpotomy compare with the conventional treatment


Original Primary Outcome: Evaluation of the success rate (%) at 1 year by clinical and radiological examination [ Time Frame: Follow up at 1 year for all patients included in the study ]

to evaluate the clinical (pain and functionality of the tooth) and radiological (absence of periapical lesion) success of both of the studie's two arms, in order to point the non-inferiority of the pulpotomy VS the conventional treatment


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Dates:
Date Received: May 30, 2016
Date Started: April 2016
Date Completion: April 2021
Last Updated: October 6, 2016
Last Verified: October 2016