NCT01737229

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

November 6, 2012

Completed
23 days until next milestone

First Posted

Study publicly available on registry

November 29, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

July 24, 2013

Status Verified

July 1, 2013

Enrollment Period

3.2 years

First QC Date

November 6, 2012

Last Update Submit

July 23, 2013

Conditions

Tooth Injury

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Long term efficacy and safety

    2 years

Study Arms (6)

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.

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.

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.

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

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.

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

Device: Application of Biodentine™ (RD94), dentin substitute

Interventions

Application of Biodentine™ (RD94), dentin substituteDEVICE
Apexification - children (7 to 18 years) + adultsDirect pulp capping/carious exposureDirect pulp capping/dental traumaPulpotomy in primary molars - children (3 to 12 years )Repairing root canals/pulp chamber floorRetrograde endodontic surgery - adults

Eligibility Criteria

Age3 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • +4 more criteria

You may not qualify if:

  • History of malignancy in the last 5 years.
  • Risk A cardiopathies 4. Known hypersensitivity to one of the components of the study or procedural medications.
  • \. 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.
  • \. Participation in another clinical study at the same time as the present study.
  • \. Known pregnancy or lactation at study entry.
  • 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
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Cabinet de Chirurgie Dentaire rue Saint Didier

Paris, France

Location

Service d'endodontie de la Pitié Salpêtrière Hôpital de la Pitié Salpêtrière

Paris, France

Location

Service d'Odontologie Hôpital Rothschild

Paris, France

Location

MeSH Terms

Conditions

Tooth Injuries

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesWounds and Injuries

Study Officials

  • Frédéric RILLIARD, Pr

    Université Paris 7-Denis Diderot

    PRINCIPAL INVESTIGATOR

  • Chantal Naulin-Ifi, Docteur

    Service d'Odontologie du GHPS

    PRINCIPAL INVESTIGATOR

  • Pierre Colon, Pr

    Université Paris VII Garancière.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2012

First Posted

November 29, 2012

Study Start

January 1, 2010

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

July 24, 2013

Record last verified: 2013-07

Locations

FR(3)