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

Septodont

Status

Active, not recruiting

Conditions

Root Canal Obturation

Treatments

Device: ready-to-use root canal sealer: PA1704

Device: root canal sealer: BioRoot™ RCS

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04757753

20/001

2020-A01790-39-PP (Other Identifier)

CIV-BE-20-10-034945 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

160 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).