RD94
Open Trial, Not Randomized Study Evaluating the Efficacy and the Tolerance of RD94 in Patients Needing Endodontic Care, Medical Device Class III
Sponsor study identifier
interventional
53
1 country
3
Study Start
January 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2013
Actual (reported)Study Completion
April 2013
Actual (reported)TRIAL TITLE Open trial, not randomized study evaluating the efficacy and the tolerance of RD94 in patients needing endodontic care, medical device class III. SPONSOR: SEPTODONT, 58 rue de 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: 09/001 PRODUCT NAME: Biodentine™ (RD94) MEDICAL DEVICE: Class: Bioactive dental substitute (Tricalcium silicate) Dose: not applicable Application : one single time DEVELOPMENTAL PHASE: not applicable (medical device class III)
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2013
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2010
Date type not reportedThis date has not been verified as actual or estimated.
November 6, 2012
Actual (reported)November 29, 2012
Actual (reported)April 2013
Actual (reported)April 2013
Actual (reported)Efficacy
The primary objective is to show that RD94 can be easily applied in the claimed indications and to evaluate its efficacy. This can be defined after a 3 month follow-up.
3 months
Long term efficacy and safety
2 years
symptomatic (provoked pain) or asymptomatic mature or immature tooth that presented pulp exposure when scraping out carious lesions or performing cavity preparation.
• Permanent mature or immature single-root tooth having suffered traumatic injury \< 72 hours, with amelodentinal coronal fracture causing pulp exposure.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Cabinet de Chirurgie Dentaire rue Saint Didier
Paris, France
Service d'endodontie de la Pitié Salpêtrière Hôpital de la Pitié Salpêtrière
Paris, France
Service d'Odontologie Hôpital Rothschild
Paris, France
Frédéric RILLIARD, Pr
Université Paris 7-Denis Diderot
Chantal Naulin-Ifi, Docteur
Service d'Odontologie du GHPS
Pierre Colon, Pr
Université Paris VII Garancière.
53 participants (actual enrollment reported by the registry).
First Submitted
November 6, 2012
First Posted
November 29, 2012
Study Start
January 2010
Date type not reportedThis date has not been verified as actual or estimated.
Luting Cements for Prefabricated Zirconia Crown Retention in Primary Anterior Teeth in Children
* Iatrogenic perforation of the pulpal floor, with or without LEO. * Iatrogenic perforated root canals following post space preparation involving dentin matrix, with or without LEO. * Iatrogenic perforated root canals with stripping not involving dentin matrix, with or without LEO.
* Failure of endodontic treatment or retreatment, evidenced by recent or persistent clinical or radiological signs of LEO and/or symptoms on a tooth in which the root canal filling looks to be of sufficiently good quality, provided that a working coronal restoration is in place. * Failure of endodontic treatment evidenced by recent or persistent clinical or radiological signs of LEO and/or symptoms on a tooth in which the root canal filling is inadequate, when orthograde retreatment does not offer a more favorable risk-benefit ratio than the surgery option
* Molar presenting deep carious lesion without irreversible pulpal disease, as the molar has to stay on the dental arch for at least 3 years. * Pulp exposure during excision of a carious lesion on a temporary molar that does not present irreversible pulp disease. The molar has to stay of the dental arch for at least 3 years.
* Permanent immature single-root tooth having suffered periodontal or dentoalveolar injury causing pulp necrosis with or without periapical disease (LEO) in children, teenagers or adult patients. * Permanent immature single-root tooth presenting pulp necrosis with or without periapical disease (LEO) in children. * Apical Root Resorption
Contact the study team to confirm eligibility.
Primary Completion
April 2013
Actual (reported)Study Completion
April 2013
Actual (reported)Last Updated
July 24, 2013
Record last verified: 2013-07
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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