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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ascopharm Groupe Novasco
ClinicalTrials.gov Identifier:
NCT01728532
First received: November 6, 2012
Last updated: January 19, 2015
Last verified: January 2015
  Purpose

TRIAL TITLE: Open, randomized multicentric trial evaluating the efficacy and the clinical tolerance of PA0903 as root canal sealer

SPONSOR:

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

MEDICAL DEVICE:

Class III: Root canal sealer Dose: not applicable Application : one single time

DEVELOPMENTAL PHASE: not applicable (medical device class III)


Condition Intervention
Root Canal Obturation
Device: Pulp Canal Sealer (Kerr)
Device: PA0903

Study Type: Interventional
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

Further study details as provided by Ascopharm Groupe Novasco:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.


Estimated Enrollment: 60
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)
Arms Assigned Interventions
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
Experimental: PA0903
type C implant according to ISO 7405:2008 and ISO 10993 guidelines.
Device: PA0903
Sealing performed by the dentist , coronal obturation placed after the canal obturation

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Male or female >18 years old
  • provide signed, informed consent.
  • be affiliated to social security.

In addition, the subjects must fulfill all of the following criteria for root canal sealer treatment:

  • Permanent mature single rooted teeth : maxillary incisors, mandibular incisor with only one canal, upper and lower canine, upper and lower premolars with only one canal
  • Permanent mature mandibular molars Pulp status
  • Vital pulp that needs pulpectomy without clinical and/or radiological findings of apical periodontitis.
  • Irreversible pulpitis with or without pain
  • Non infected tooth that positively responds of pulp vitality test Or necrotic pulp with and without radiographic signs of apical pathosis Periodontal status
  • No active periodontal disease

Exclusion criteria:

  • History of malignancy in the last 5 years.
  • Systemic disease not stabilized within 1 month before the Inclusion Visit (e.g., diabetes, thyroid malfunction, uncontrolled autoimmune disease) or judged by the investigator to be incompatible with the study (e.g. current systemic infections) or condition incompatible with the frequent assessments needed by the study.
  • Risk A cardiopathies
  • Known hypersensitivity to one of the components of the study or procedural medications.
  • Presence or history of severe systemic allergy.
  • Presence or history of drug addiction or alcohol abuse.
  • Patient who has participated in a clinical trial with a new active substance during the month before study entry.
  • Participation in another clinical study at the same time as the present study.
  • Known pregnancy or lactation at study entry.
  • Patients with legal protection

Specific criteria relative to root canal sealing are:

  • Extreme curvature of the canals
  • Dilacerations
  • Root dilacerations and sharp apical curvature for mandibular molars
  • Superimposition of mesial canals for mandibular molar
  • Large peri-apical radiolucencies
  • Periodontal disease
  • Not primary endodontic treatment
  • Perforated root canals
  • Supracrestal iatrogenic perforation
  • Inadequate or insufficient periodontal support
  • Combined endo-periodontal lesion
  • Loss of tooth structure (Coronal decay and/or concomitant root decay) compromising the tooth's maintenance on the dental arch)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01728532

Locations
France
Cabinet dentaire privé - 21, rue Fabre d'Églantine
Paris, France
Service d'endodontie de la Pitié Salpêtrière Hôpital de la Pitié Salpêtrière
Paris, France
United Kingdom
School of Dentistry Cardiff University
Cardiff, United Kingdom
Sponsors and Collaborators
Ascopharm Groupe Novasco
Investigators
Principal Investigator: Stéphane Simon, PhD Hôpital Pitié Salpetrière, Paris, France
  More Information

No publications provided

Responsible Party: Ascopharm Groupe Novasco
ClinicalTrials.gov Identifier: NCT01728532     History of Changes
Other Study ID Numbers: 11/001
Study First Received: November 6, 2012
Last Updated: January 19, 2015
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
United Kingdom: Medicines and Healthcare Products Regulatory Agency

ClinicalTrials.gov processed this record on June 30, 2015