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Clinical Trials in France / NCT04757753
Active, not recruiting Not applicable

Root Canal Obturation With a Ready-to-use Root Canal Sealer (PA1704) Versus BioRoot™ RCS: a Randomized Controlled Trial

NCT04757753 · tracked via the Priya Life Science France tracker
Sponsor
Septodont
Phase
Not applicable
Started
2020-11-06
Last updated
2026-06-08

Condition(s) studied

Root Canal Obturation

Investigational drug(s) / intervention(s)

ready-to-use root canal sealer: PA1704root canal sealer: BioRoot™ RCS

ready-to-use root canal sealer: PA1704: The participant will be treated with the ready-to-use root canal sealer (PA1704) in combination with gutta percha.

root canal sealer: BioRoot™ RCS: The participant will be treated with BioRoot™ RCS sealer in combination with gutta percha.

Study 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 group). The aim of the study is to assess the efficacy rate and the safety 2 years after root canal obturation undertaken using a ready-to-use calcium silicate sealer (PA1704) compared to the control calcium silicate sealer BioRoot™ RCS.

Procedures of root canal treatment will be conventional and standardized for all investigational centers. The canals will be cleaned, shaped and then obturated using a calcium silicate sealer (the ready to use sealer PA1704 or BioRoot™ RCS) with a single cone technique or cold lateral condensation of gutta-percha. Follow-up assessments will be conducted at 6, 12 and 24 months in both groups. The performance and safety of the sealer PA1704 will also be evaluated at 3.5 and 5 years after surgery. Retroalveolar radiographs will be taken at each study visit. The preoperative, postoperative and follow-up clinical and radiographic data will be analyzed.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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).

Primary outcome measure(s)

  • Efficacy Rate of Root Canal Obturation — 24 months post-treatment
    Efficacy rate of root canal obturation using clinical and radiological criteria. A successfull treatment is defined in this study, based on some loose criteria, as: a functional tooth with no lesion on the radio, or a functional tooth with a size reduction of the lesion on the radio, or a functional tooth with a lesion size stabilisation.

Trial sites (5)

FacilityCityRegionStatus
Cliniques Universitaires Saint-Luc, Département de Médecine Dentaire et de Stomatologie Brussels Belgium
Centre de santé dentaire Flandre Paris France
Cabinet dentaire Rennes France
Cabinet dentaire Jeanne d'Arc Rouen France
Cabinet dentaire Saint-Grégoire France

More Septodont trials in France

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Long-term Performance and Safety of Biodentine™ in Patients Treated for Endodontic Indications Active, not recruiting
Tooth Retention After Root Canal Treatment With Endomethasone N Active, not recruiting
Measurement of the Clinical and Radiological Performance Impact of the Root Canal Treatment With BioRootTM RCS. Active, not recruiting
Measurement of the Performance and Safety of RTR+Membrane in Guided Tissue Regeneration (GTR) in Dental Surgical Procedures Active, not recruiting

Other trials for the same condition

Measurement of the Clinical and Radiological Performance Impact of the Root Canal Treatment With BioRootTM RCS. Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04757753 on ClinicalTrials.gov ↗ ← All trials in France