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

Study Results

Results available

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-06

Study Completion Date

2026-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Root Canal Obturation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Study subject (tooth) will be randomized in a 1:1 allocation ratio between the 2 treatment groups; the allocation will be stratified by the endodontic indication, i.e. primary or secondary root canal treatment, to enhance balance.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Blinding will be done to the assessors who analyzed radiographs to reduce bias to healing assessment.

Study Groups

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ready-to-use root canal sealer: PA1704

PA1704 is used in combination with gutta percha points for the permanent obturation of root canals.

Group Type EXPERIMENTAL

ready-to-use root canal sealer: PA1704

Intervention Type DEVICE

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

root canal sealer: BioRoot™ RCS

BioRoot™ RCS is used in combination with gutta percha points for the permanent obturation of root canals.

Group Type OTHER

root canal sealer: BioRoot™ RCS

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

root canal sealer: BioRoot™ RCS

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

Intervention Type DEVICE

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No