Tooth InjuryRD94NCT01737229
Efficacy and the Safety Study of RD94 in Patients With Endodontic Care
A study testing Application of Biodentine™ (RD94), dentin substitute in people with Tooth Injury, run by Ascopharm Groupe Novasco at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Tooth Injury
- What is being tested?
- Application of Biodentine™ (RD94), dentin substitute
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 3 sitesFrance
- Study dates
- Jan 2010to Apr 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 19Show fewer
- 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
Who cannot join
- 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.
Show all 26Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites
Cabinet de Chirurgie Dentaire rue Saint Didier
Paris
Service d'endodontie de la Pitié Salpêtrière Hôpital de la Pitié Salpêtrière
Paris
Service d'Odontologie Hôpital Rothschild
Paris
About this study
Official title: Open Trial, Not Randomized Study Evaluating the Efficacy and the Tolerance of RD94 in Patients Needing Endodontic Care, Medical Device Class III
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)
Read the 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.
- Conditions
- Tooth Injury
- Being tested
- Application of Biodentine™ (RD94), dentin substitute
- Medical subject headings
- Tooth Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of Biodentine™ (RD94), dentin substituteDevice
| Study group | Role | What they receive |
|---|---|---|
| Direct pulp capping/carious exposure | Experimental | symptomatic (provoked pain) or asymptomatic mature or immature tooth that presented pulp exposure when scraping out carious lesions or performing cavity preparation. Receives: Device: Application of Biodentine™ (RD94), dentin substitute |
| Direct pulp capping/dental trauma | Experimental | • Permanent mature or immature single-root tooth having suffered traumatic injury < 72 hours, with amelodentinal coronal fracture causing pulp exposure. Receives: Device: Application of Biodentine™ (RD94), dentin substitute |
| Repairing root canals/pulp chamber floor | Experimental | * 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. Receives: Device: Application of Biodentine™ (RD94), dentin substitute |
| Retrograde endodontic surgery - adults | Experimental | * 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 Receives: Device: Application of Biodentine™ (RD94), dentin substitute |
| Pulpotomy in primary molars - children (3 to 12 years ) | Experimental | * 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. Receives: Device: Application of Biodentine™ (RD94), dentin substitute |
| Apexification - children (7 to 18 years) + adults | Experimental | * 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 Receives: Device: Application of Biodentine™ (RD94), dentin substitute |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (1)
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2012 (estimated)
- Study startJan 2010
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ascopharm Groupe Novasco
- Sponsor type
- University, hospital or other
- Collaborators
- AscoPharm is conducting the study under the responsibility of SEPTODONT
- Responsible party
- Sponsor
- Investigators
- Frédéric RILLIARD, Pr, Principal investigator, Université Paris 7-Denis DiderotChantal Naulin-Ifi, Docteur, Principal investigator, Service d'Odontologie du GHPSPierre Colon, Pr, Principal investigator, Université Paris VII Garancière.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01737229
- Sponsor's protocol ID
- 09/001
- Acronym
- RD94
- Status last verified
- Jul 2013
- First submitted
- 6 Nov 2012
- Last updated
- 24 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Trial, Not Randomized Study Evaluating the Efficacy and the Tolerance of RD94 in Patients Needing Endodontic Care, Medical Device Class III
- ClinicalTrials.gov ID
- NCT01737229
- Acronym / sponsor ID
- RD94 / 09/001
- Conditions
- Tooth Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Ascopharm Groupe NovascoUniversity, hospital or other
- Collaborators
- AscoPharm is conducting the study under the responsibility of SEPTODONT
- Study start
- Jan 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 29 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Direct pulp capping/carious exposure | Experimental | Device: Application of Biodentine™ (RD94), dentin substitutesymptomatic (provoked pain) or asymptomatic mature or immature tooth that presented pulp exposure when scraping out carious lesions or performing cavity preparation. |
| Direct pulp capping/dental trauma | Experimental | Device: Application of Biodentine™ (RD94), dentin substitute• Permanent mature or immature single-root tooth having suffered traumatic injury < 72 hours, with amelodentinal coronal fracture causing pulp exposure. |
| Repairing root canals/pulp chamber floor | Experimental | Device: Application of Biodentine™ (RD94), dentin substitute* 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 | Experimental | Device: Application of Biodentine™ (RD94), dentin substitute* 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 ) | Experimental | Device: Application of Biodentine™ (RD94), dentin substitute* 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 | Experimental | Device: Application of Biodentine™ (RD94), dentin substitute* 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 |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (19 listed)
- 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.
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Application of Biodentine™ (RD94), dentin substitute | Device | Apexification - children (7 to 18 years) + adults, Direct pulp capping/carious exposure, Direct pulp capping/dental trauma, Pulpotomy in primary molars - children (3 to 12 years ), Repairing root canals/pulp chamber floor, Retrograde endodontic surgery - adults |
Primary outcome
Efficacy
Time frame: 3 months
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.
1 secondary outcome
Long term efficacy and safety
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frédéric RILLIARD, Pr principal investigator
Université Paris 7-Denis Diderot
Chantal Naulin-Ifi, Docteur principal investigator
Service d'Odontologie du GHPS
Pierre Colon, Pr principal investigator
Université Paris VII Garancière.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Application of Biodentine™ (RD94), dentin substitute in people with Tooth Injury, run by Ascopharm Groupe Novasco at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2013.