Status:
ACTIVE_NOT_RECRUITING
Root Canal Obturation With a Ready-to-use Root Canal Sealer (PA1704) Versus BioRoot™ RCS: a Randomized Controlled Trial
Lead Sponsor:
Septodont
Collaborating Sponsors:
Slb Pharma
Conditions:
Root Canal Obturation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The study design is a multicentric randomized controlled non-inferiority trial. 160 subjects (teeth) requiring a primary or a secondary root canal treatment will be enrolled in 2 groups (80 in each gr...
Eligibility Criteria
Inclusion
- Adult male or female (age ≥ 18 years)
- Patient requiring a primary or a secondary root canal obturation on a single or multi-rooted tooth,
- Patient geographically stable who can be followed by the same investigator site for 2 years,
- Informed consent signed,
- Patient with social protection
Exclusion
- Patient with one or more documented contraindication to endodontic treatment,
- Contraindication to the use of calcium silicate root canal sealer, such as an immature tooth or a known hypersensitivity to one component of the sealer formula,
- Endodontic treatment on tooth with calcified root canal assessed radiographically,
- Endodontic treatment on tooth with suspected perforation,
- Patient with an uncontrolled systemic disease such as diabetes or thyroid disorders, or with an immunocompromised condition or who has undergone radiation therapy to the jaw.
- Patient suffering from uncontrolled active periodontitis, not supported
- Participation to another interventional clinical study at the same time,
- Vulnerable subjects referred to in articles L.1121-5 to 8 and L.1122-1-2 of the Public Health Code and article 66 of Regulation (EU) 2017/745 on medical devices are excluded from the investigation (such as known pregnancy or lactation, patients with legal protection).
Key Trial Info
Start Date :
November 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2026
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT04757753
Start Date
November 6 2020
End Date
July 1 2026
Last Update
June 26 2025
Active Locations (5)
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1
Cliniques Universitaires Saint-Luc, Département de Médecine Dentaire et de Stomatologie
Brussels, Belgium, 1200
2
Centre de santé dentaire Flandre
Paris, France, 75019
3
Cabinet dentaire
Rennes, France, 35000
4
Cabinet dentaire Jeanne d'Arc
Rouen, France, 76000