NCT04757753

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 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.

Trial Health

78
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
2mo left

Started Nov 2020

Longer than P75 for not_applicable

Geographic Reach
2 countries

5 active sites

Status
active not recruiting

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 Progress97%
Nov 2020Jul 2026

Study Start

First participant enrolled

November 6, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 17, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2023

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

October 10, 2024

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

June 26, 2025

Status Verified

June 1, 2025

Enrollment Period

2.8 years

First QC Date

February 12, 2021

Results QC Date

April 15, 2024

Last Update Submit

June 18, 2025

Conditions

Root Canal Obturation

Keywords

endodontic treatmentroot canal sealerperiapical lesion

Outcome Measures

Primary Outcomes (1)

  • Efficacy Rate of Root Canal Obturation

    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.

    24 months post-treatment

Secondary Outcomes (5)

  • Efficacy Rate of Root Canal Obturation

    12 months post-treatment

  • Efficacy Rate of Root Canal Obturation

    6 months post-treatment

  • Radiological Evaluation of the Canal Obturation

    24-months post-treatment

  • Postoperative Pain

    Before endodontic treatment*; before session#2 initiation**; T0 (after canal obturation); 12; 24; 48; & 72h; 7 days after endodontic treatment. *Evaluation on same day for 1-session treatment; up to 18 days before if 2 sessions needed. **On same day.

  • Use of Oral Pain Treatment

    From Day 0 to Day 7

Study Arms (2)

ready-to-use root canal sealer: PA1704

EXPERIMENTAL

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

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

root canal sealer: BioRoot™ RCS

OTHER

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

Device: root canal sealer: BioRoot™ RCS

Interventions

ready-to-use root canal sealer: PA1704DEVICE

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

ready-to-use root canal sealer: PA1704
root canal sealer: BioRoot™ RCSDEVICE

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

root canal sealer: BioRoot™ RCS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Cliniques Universitaires Saint-Luc, Département de Médecine Dentaire et de Stomatologie

Brussels, 1200, Belgium

Location

Centre de santé dentaire Flandre

Paris, 75019, France

Location

Cabinet dentaire

Rennes, 35000, France

Location

Cabinet dentaire Jeanne d'Arc

Rouen, 76000, France

Location

Cabinet dentaire

Saint-Grégoire, 35760, France

Location

Related Publications (1)

  • Simon S, Beauquis J, Colombel H, Dorn A, Marchi V, Robert S, Souleau G, Ravalec N, Huguet-Jaime F, Chazaud K, Serandour AL, Ournid N, Leprince JG. Clinical efficacy of root canal treatment at 2 years using a new ready-to-use injectable calcium silicate-based sealer: A multicentric randomised controlled trial. Int Endod J. 2025 Sep;58(9):1420-1432. doi: 10.1111/iej.14265. Epub 2025 Jun 10.

    PMID: 40491343RESULT

Results Point of Contact

Title
Dr. Farid BENABDALLAH
Organization
SEPTODONT
clinical-operations@septodont.com
+33785662179

Study Officials

  • Stéphane Simon, Pr, DDS

    Cabinet dentaire Jeanne d'Arc - ROUEN (76000) - France

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Blinding will be done to the assessors who analyzed radiographs to reduce bias to healing assessment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2021

First Posted

February 17, 2021

Study Start

November 6, 2020

Primary Completion

August 29, 2023

Study Completion (Estimated)

July 1, 2026

Last Updated

June 26, 2025

Results First Posted

October 10, 2024

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)FR(4)