Open, Multicentric Trial Evaluating the Efficacy and the Clinical Tolerance of PA0903 as Root Canal Sealer

• clinical and radiographic outcome of PA0903 as root canal sealer [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  clinical and radiographic outcome of root canal treatment at two years when using PA0903 as an endodontic sealer with gutta-percha. The success rate is defined as no pain (score of 0 at the VAS scale) and no LEO (fulfilment of Strindberg's criteria) Treatment was considered successful when the contours, width, and structure of the periodontal margins were normal.
  
  

• Secondary outcomes [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

  The success rate at each time point and also the components of this composite variable (i.e. pain andfulfillment of Strindberg's criteria ).

  • the handling, consistency and physical characteristics of PA0903
  • the longevity and safety of the product associated with PA0903 after two years.
  
  

METHODOLOGY:

This study is performed only in adults who required a non-surgical root canal obturation. The studied indication is the root canal sealing.

This multi-centre and open-label study comprises two groups corresponding to tested root canal sealer (a reference product and investigational product). Randomization is required.

Investigational product that is a dental cement based on biosilicate technology (PA0903) will be applied with lateral compaction or single cone technique. On the contrary, reference product that is a zinc oxide-eugenol used in dental practice (Pulp Canal Sealer) will be applied with a single wave technique.

Study start: 01/12/11

Inclusion period: 6 months

Study duration: 2 years after the end of inclusion period

OBJECTIVES: The trial objective is to illustrate the clinical and radiographic outcome of PA0903 in the described indication.

Primary objectives:

The primary objective is to evaluate: clinical and radiographic outcome of root canal treatment at two years when using PA0903 as an endodontic sealer with gutta-percha. The success rate is defined as no pain (score of 0 at the VAS scale) and no LEO (fulfilment of Strindberg's criteria) Treatment was considered successful when the contours, width, and structure of the periodontal margins were normal. All cases in which those criteria were not fulfilled were judged as unsuccessful. A follow-up of two years is described as the predictive time of success.Secondary objective: The secondary objectives are to evaluate the following criteria and in an indicative way, to compare them between patients receiving the PA0903 and those receiving the reference product:

• The success rate at each time point and also the components of this composite variable (i.e. pain andfulfillment of Strindberg's criteria ).
• the handling, consistency and physical characteristics of PA0903
• the longevity and safety of the product associated with PA0903 after two years.

TRIAL POPULATION AND NUMBER OF PATIENTS: about 60 patients will have to be included in the study, 20 by center with a ratio 2 (PA0903): 1 (reference). Adults will be included without gender distinction.

Coordinating center Endodotontic service of Pitié Salpétrière Pitié Salpétrière Hospital 75634 Paris Cedex 13 France

DURATION OF TREATMENT:

The product is applied on D0 (inclusion) of the study. The follow-up period includes 2 years with 4 visits: Visit 1(Week 2), Visit 2 (Month 6), Visit 3 (Year 1) and Visit 4 (Year 2).