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

NCT01728532 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2016-12-01

No results posted yet for this study

Summary

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)

Conditions

  • Root Canal Obturation

Interventions

DEVICE

Pulp Canal Sealer (Kerr)

permanent obturation of the root canal space with the aid of obturating points

DEVICE

PA0903

Sealing performed by the dentist , coronal obturation placed after the canal obturation

Sponsors & Collaborators

  • Ascopharm Groupe Novasco

    lead OTHER

Principal Investigators

  • Stéphane Simon, PhD · Hôpital Pitié Salpetrière, Paris, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • France
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01728532 on ClinicalTrials.gov