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Efficacy and the Safety Study of RD94 in Patients With Endodontic Care (RD94)

Primary Purpose

Tooth Injury

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Application of Biodentine™ (RD94), dentin substitute
Sponsored by
Ascopharm Groupe Novasco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Injury

Eligibility Criteria

3 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

  • provide signed, informed consent.
  • be affiliated to social security. criteria for the corresponding indication: Direct pulp capping following carious pulp exposure - children (6 to 18 years) + adults
  • Symptomatic or asymptomatic mature or immature tooth that presented pulp exposure when scraping out carious lesions or performing cavity preparation.

Direct pulp capping following dental trauma injury to healthy pulp, reformulated as a partial pulpotomy - children (6 to 18 years) + adults

- Permanent mature or immature single-root tooth having suffered traumatic injury < 72 hours, with amelodentinal coronal fracture causing pulp exposure.

Repairing perforated root canals and/or the pulp chamber floor - adults

  • 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.

Retrograde endodontic surgery - adults

  • 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.

Pulpotomy in primary molars - children ( 3 to 12 years )

  • 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.

Apexification - children (7 to 18 years) + adults

  • 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

Exclusion Criteria

  1. History of malignancy in the last 5 years.
  2. Systemic disease not stabilized within 1 month before the Inclusion Visit or judged by the investigator to be incompatible with the study 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.

exclusion criteria for each indication : Direct pulp capping following carious pulp exposure

  • Chronic irreversible pulpitis
  • Pulp necrosis
  • Anterior or saliva-contaminated tooth pulp exposure
  • Accidental exposure occurring during non-retentive prosthetic preparation Direct pulp capping following dental trauma injury to healthy pulp, reformulated as a partial pulpotomy
  • Pulp exposure period > 72 hours
  • Crown-root fracture
  • Pulpal necrosis with or without periapical disease(LEO)

Repairing perforated root canals and/or the pulp chamber floor

  • Supracrestal iatrogenic perforation
  • Inadequate periodontal support
  • Loss of tooth structure (Coronal decay and/or concomitant root decay) compromising the tooth's maintenance on the dental arch) Retrograde endodontic surgery
  • 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, when a working coronal restoration is either missing or presents microleakage
  • 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 surgical treatment does not offer a more favorable risk-benefit ratio than the orthograde retreatment option
  • Insufficient periodontal support, endo-periodontal lesion
  • Coronal decay and/or concomitant root decay compromising the tooth's maintenance on the dental arch
  • Maxillary intrabony lesion of suspected non-endodontic origin

Pulpotomy:

  • Temporary molar expected to begin exfoliation within 24 months.
  • Molar presenting signs of irreversible pulp disease - spontaneous pain

Sites / Locations

  • Cabinet de Chirurgie Dentaire rue Saint Didier
  • Service d'endodontie de la Pitié Salpêtrière Hôpital de la Pitié Salpêtrière
  • Service d'Odontologie Hôpital Rothschild

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Direct pulp capping/carious exposure

Direct pulp capping/dental trauma

Repairing root canals/pulp chamber floor

Retrograde endodontic surgery - adults

Pulpotomy in primary molars - children (3 to 12 years )

Apexification - children (7 to 18 years) + adults

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Long term efficacy and safety
The secondary objective is to evaluate the efficacy of RD94 after a two year follow-up which is important for safety and the longevity of the product.

Full Information

First Posted
November 6, 2012
Last Updated
July 23, 2013
Sponsor
Ascopharm Groupe Novasco
Collaborators
AscoPharm is conducting the study under the responsibility of SEPTODONT
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1. Study Identification

Unique Protocol Identification Number
NCT01737229
Brief Title
Efficacy and the Safety Study of RD94 in Patients With Endodontic Care
Acronym
RD94
Official Title
Open Trial, Not Randomized Study Evaluating the Efficacy and the Tolerance of RD94 in Patients Needing Endodontic Care, Medical Device Class III
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ascopharm Groupe Novasco
Collaborators
AscoPharm is conducting the study under the responsibility of SEPTODONT

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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)
Detailed Description
METHODOLOGY: This multi-centre and open-label study comprises six groups corresponding to the six indications tested. No placebo or reference product is involved. No randomization is required as the indication will define the patient selection. The six indications studied are: Direct pulp capping following carious pulp exposure Direct pulp capping following dental trauma injury to healthy pulp (partial pulpotomy) Repairing perforated root canals and/or the pulp chamber floor Retrograde endodontic surgery Pulpotomy in primary molars Apexification Study start: October 2009 Inclusion period: 1/10/2009 to 30/06/2011 Study duration: 2 years OBJECTIVES: The trial objective is to illustrate the clinical efficacy and tolerance of RD94 in the indications described. Primary objective: 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 6 month follow-up. Secondary objective: The secondary objective is to evaluate the efficacy of RD94 after a two year follow-up which is important for safety and the longevity of the product. TRIAL POPULATION AND NUMBER OF PATIENTS: 60 patients in three French study centers, 10 per indication studied. Depending on the indication, children (from 3 years onwards), and/or adults will be included. DURATION OF TREATMENT: The product is applied on D0 (Inclusion) of the study. The follow-up period includes 2 years with six visits: Visit1 - Week 1, Visit 2 - Month 1, Visit 3 - Month 3, Visit 4 - Month 6, Visit 5 - Year 1, Visit 6 - Year 2.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Direct pulp capping/carious exposure
Arm Type
Experimental
Arm Description
symptomatic (provoked pain) or asymptomatic mature or immature tooth that presented pulp exposure when scraping out carious lesions or performing cavity preparation.
Arm Title
Direct pulp capping/dental trauma
Arm Type
Experimental
Arm Description
• Permanent mature or immature single-root tooth having suffered traumatic injury < 72 hours, with amelodentinal coronal fracture causing pulp exposure.
Arm Title
Repairing root canals/pulp chamber floor
Arm Type
Experimental
Arm Description
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.
Arm Title
Retrograde endodontic surgery - adults
Arm Type
Experimental
Arm Description
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
Arm Title
Pulpotomy in primary molars - children (3 to 12 years )
Arm Type
Experimental
Arm Description
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.
Arm Title
Apexification - children (7 to 18 years) + adults
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Application of Biodentine™ (RD94), dentin substitute
Primary Outcome Measure Information:
Title
Efficacy
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Long term efficacy and safety
Description
The secondary objective is to evaluate the efficacy of RD94 after a two year follow-up which is important for safety and the longevity of the product.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria provide signed, informed consent. be affiliated to social security. criteria for the corresponding indication: Direct pulp capping following carious pulp exposure - children (6 to 18 years) + adults Symptomatic or asymptomatic mature or immature tooth that presented pulp exposure when scraping out carious lesions or performing cavity preparation. Direct pulp capping following dental trauma injury to healthy pulp, reformulated as a partial pulpotomy - children (6 to 18 years) + adults - Permanent mature or immature single-root tooth having suffered traumatic injury < 72 hours, with amelodentinal coronal fracture causing pulp exposure. Repairing perforated root canals and/or the pulp chamber floor - adults 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. Retrograde endodontic surgery - adults 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. Pulpotomy in primary molars - children ( 3 to 12 years ) 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. Apexification - children (7 to 18 years) + adults 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 Exclusion Criteria History of malignancy in the last 5 years. Systemic disease not stabilized within 1 month before the Inclusion Visit or judged by the investigator to be incompatible with the study 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. exclusion criteria for each indication : Direct pulp capping following carious pulp exposure Chronic irreversible pulpitis Pulp necrosis Anterior or saliva-contaminated tooth pulp exposure Accidental exposure occurring during non-retentive prosthetic preparation Direct pulp capping following dental trauma injury to healthy pulp, reformulated as a partial pulpotomy Pulp exposure period > 72 hours Crown-root fracture Pulpal necrosis with or without periapical disease(LEO) Repairing perforated root canals and/or the pulp chamber floor Supracrestal iatrogenic perforation Inadequate periodontal support Loss of tooth structure (Coronal decay and/or concomitant root decay) compromising the tooth's maintenance on the dental arch) Retrograde endodontic surgery 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, when a working coronal restoration is either missing or presents microleakage 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 surgical treatment does not offer a more favorable risk-benefit ratio than the orthograde retreatment option Insufficient periodontal support, endo-periodontal lesion Coronal decay and/or concomitant root decay compromising the tooth's maintenance on the dental arch Maxillary intrabony lesion of suspected non-endodontic origin Pulpotomy: Temporary molar expected to begin exfoliation within 24 months. Molar presenting signs of irreversible pulp disease - spontaneous pain
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frédéric RILLIARD, Pr
Organizational Affiliation
Université Paris 7-Denis Diderot
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chantal Naulin-Ifi, Docteur
Organizational Affiliation
Service d'Odontologie du GHPS
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pierre Colon, Pr
Organizational Affiliation
Université Paris VII Garancière.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cabinet de Chirurgie Dentaire rue Saint Didier
City
Paris
Country
France
Facility Name
Service d'endodontie de la Pitié Salpêtrière Hôpital de la Pitié Salpêtrière
City
Paris
Country
France
Facility Name
Service d'Odontologie Hôpital Rothschild
City
Paris
Country
France

12. IPD Sharing Statement

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Efficacy and the Safety Study of RD94 in Patients With Endodontic Care

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