Open, Multicentric Trial Evaluating the Efficacy and the Clinical Tolerance of PA0903 as Root Canal Sealer (PA0903)
TRIAL TITLE: Open, randomized multicentric trial evaluating the efficacy and the clinical tolerance of PA0903 as root canal sealer
SEPTODONT, 58 rue du Pont de Créteil, 94107 Saint Maur des Fossés cedex Tel : + 33 1-49-76-74-26, Fax. : + 33 1- 49-76-71-91
Reference protocol: 11/001
PRODUCT NAME: PA0903
Class III: Root canal sealer Dose: not applicable Application : one single time
DEVELOPMENTAL PHASE: not applicable (medical device class III)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Open, Randomized 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 ]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 absence or decrease in the size of LEO (fulfilment of Strindberg's criteria). If a pre-existing lesion, the size decrease associated with normal contours, width and structure of the periodontal margines is considered as success. All cases in which lesion increases or is stabilized after 2 years were judged as unsuccessful .A follow-up of two years is described as the predictive time of success.
- 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 and Healing process for total class (vital teeth and necrotic teeth) of endodontic status of teeth).
In case of pre-existing LEO associated with necrotic teeth, size of LEO and suitable Strindgberg's criteria will be used to judge the outcomes of the root canal therapy as described below :
At visit 2 (6 months) treatment is considered successful when LEO is stable or decreased in comparison with V0 associated with Strindberg's criteria suitable.
At V3 (1 year), treatment is considered successful when LEO is decreased in comparison with V2 associated with Strindberg's criteria suitable.
- the Healing process associated with PA0903 application in each endodontic status
- the handling, consistency and physical characteristics of PA0903
- the longevity and safety of the product associated with PA0903 after two years.
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||May 2016|
|Estimated Primary Completion Date:||May 2016 (Final data collection date for primary outcome measure)|
Active Comparator: Pulp Canal Sealer (Kerr)
zinc oxide eugenol sealer
Device: Pulp Canal Sealer (Kerr)
permanent obturation of the root canal space with the aid of obturating points
type C implant according to ISO 7405:2008 and ISO 10993 guidelines.
Sealing performed by the dentist , coronal obturation placed after the canal obturation
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01728532
|Cabinet dentaire privé - 21, rue Fabre d'Églantine|
|Service d'endodontie de la Pitié Salpêtrière Hôpital de la Pitié Salpêtrière|
|School of Dentistry Cardiff University|
|Cardiff, United Kingdom|
|Principal Investigator:||Stéphane Simon, PhD||Hôpital Pitié Salpetrière, Paris, France|