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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Ascopharm Groupe Novasco
Sponsor:
Collaborator:
Ascopharm Groupe Novasco is conducting the study under the responsibility of SEPTODONT, sponsor of the study
Information provided by (Responsible Party):
Ascopharm Groupe Novasco
ClinicalTrials.gov Identifier:
NCT01728532
First received: November 6, 2012
Last updated: November 13, 2012
Last verified: November 2012
  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 IIA: Root canal sealer Dose: not applicable Application : one single time

DEVELOPMENTAL PHASE: not applicable (medical device class IIA)


Condition Intervention
Vital Pulp That Needs Pulpectomy Without Clinical and/or Radiological Findings of Apical Periodontitis
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 ]
    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 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 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.


Estimated Enrollment: 60
Study Start Date: June 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Reference product: Pulp Canal Sealer (Kerr)
Pulp Canal Sealer is a zinc oxide eugenol sealer that has a powder base and liquid catalyst. It is used for permanent obturation of the root canal space with the aid of obturating points. It is a nontoxic and non-irritating formulation that is radiopaque and has a long history of clinical success.
Device: Pulp Canal Sealer (Kerr)
Experimental: PA0903
Investigational product: PA0903 PA0903 that is dedicated to seal the canal is class IIa medical device. Once the sealing performed with PA0903 by the dentist, a coronal obturation is always placed after the canal obturation limiting the buccal environment access. Consequently, PA0903 is a type C implant according to ISO 7405:2008 guidelines and ISO 10993 guidelines.
Device: PA0903

Detailed Description:

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).

  Eligibility

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

Inclusion Criteria

To be eligible for inclusion into this trial, all subjects have to:

  • 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 or permanent mature mandibular molars associated with positive response to cold test, with no visible apical lesion 11/001, PA0903, root canal sealer, Version 5 Page 29 of 59 Version 06/04/2012 CONFIDENTIAL
  • Primary endodontic treatment based on clinical and radiological findings
  • Vital teeth with healthy periodontium
  • No history of periodontal disease
  • Asymptomatic mature tooth
  • Vital pulp that needs pulpectomy without clinical and/or radiological findings of apical periodontitis.
  • Non infected tooth that positively responds of pulp vitality test

on Criteria

To be eligible for inclusion in this trial the subjects must not meet any of the following criteria:

1. History of malignancy in the last 5 years. 2. 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. 3 Risk A cardiopathies 4. Known hypersensitivity to one of the components of the study or procedural medications.

5. Presence or history of severe systemic allergy. 6. Presence or history of drug addiction or alcohol abuse. 7. Patient who has participated in a clinical trial with a new active substance during the month before study entry. 8. Participation in another clinical study at the same time as the present study.

9. Known pregnancy or lactation at study entry. 10. Patients with legal protection

Specific criteria relative to root canal sealing are:

  • Necrotic pulp with and without apical lesions
  • Extreme curvature of the canals
  • Dilacerations

Exclusion Criteria

  • 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)
  • Teeth presenting signs of irreversible pulp disease and spontaneous pain (signs of pulpitis)
  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

Contacts
Contact: Pierre Machtou, Pr +33 1 43 26 94 96

Locations
France
Service d'endodontie de la Pitié Salpêtrière Hôpital de la Pitié Salpêtrière Recruiting
Paris, France
Contact: Stéphane Simon, PhD         
Principal Investigator: Stéphane Simon, PhD         
Cabinet dentaire privé - 21, rue Fabre d'Églantine Recruiting
Paris, France
Contact: François Bronnec, PhD         
Principal Investigator: François Bronnec, PhD         
United Kingdom
School of Dentistry Cardiff University Recruiting
Cardiff, United Kingdom
Contact: Paul Dummer         
Principal Investigator: Paul Dummer, PhD         
Sponsors and Collaborators
Ascopharm Groupe Novasco
Ascopharm Groupe Novasco is conducting the study under the responsibility of SEPTODONT, sponsor of the study
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: November 13, 2012
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Periapical Periodontitis
Periodontitis
Periapical Diseases
Jaw Diseases
Stomatognathic Diseases
Periodontal Diseases
Mouth Diseases

ClinicalTrials.gov processed this record on July 29, 2014