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Root Canal ObturationOPTIFILLNCT04757753

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

A study testing ready-to-use root canal sealer: PA1704 and root canal sealer: BioRoot™ RCS in people with Root Canal Obturation, run by Septodont at 5 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Root Canal Obturation
What is being tested?
ready-to-use root canal sealer: PA1704 and root canal sealer: BioRoot™ RCS
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
5 sitesin 2 countries
Study dates
6 Nov 2020to Dec 2026
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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).

Trial locations and contacts

5 sites in 2 countries.

5 sites in 2 countries

France4 sites

  • Centre de santé dentaire Flandre

    Paris, 75019

  • Cabinet dentaire

    Rennes, 35000

  • Cabinet dentaire Jeanne d'Arc

    Rouen, 76000

  • Cabinet dentaire

    Saint-Grégoire, 35760

Other trials in France

Belgium1 site

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

    Brussels, 1200

Other trials in Belgium

About this study

Official title: Evaluation of the Efficacy Rate of Endodontic Treatment at 2 Years After Root Canal Filling With a Ready-to-use Root Canal Sealer PA1704 Versus BioRoot™ RCS: a Randomized Controlled Trial

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.

Being tested
ready-to-use root canal sealer: PA1704, root canal sealer: BioRoot™ RCS
Keywords
endodontic treatment, root canal sealer, periapical lesion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • root canal sealer: BioRoot™ RCSDevice

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

Study groups in NCT04757753
Study groupRoleWhat they receive
ready-to-use root canal sealer: PA1704ExperimentalPA1704 is used in combination with gutta percha points for the permanent obturation of root canals.
Receives: Device: ready-to-use root canal sealer: PA1704
root canal sealer: BioRoot™ RCSOtherBioRoot™ RCS is used in combination with gutta percha points for the permanent obturation of root canals.
Receives: Device: root canal sealer: BioRoot™ RCS

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 24 months post-treatment

Secondary outcomes (5)

  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.

    The efficacy rates was compared between the 2 groups at 12-months post-treatment.

    Measured: 12 months post-treatment

  2. 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.

    The efficacy rates was compared between the 2 groups at 6-months post-treatment.

    Measured: 6 months post-treatment

  3. Radiological Evaluation of the Canal Obturation

    Radiological evaluation of the level of apical obturation and density.

    The level of apical obturation and density is measured by the Investigators on the retroalveolar radios, like the "Sufficient radio-opacity" of the ready-to-use root canal sealer under investigation, "Presence of at least one bubble (void) in the filling material", and "If extruded material at T0, extruded material still presents in the periapical space".

    Measured: 24-months post-treatment

  4. Postoperative Pain

    The pain is assessed by patients in a diary using a Visual Analogue Scale (VAS: 0-100 mm, from no pain to max pain) at different times after endodontic treatment (at the end of the root canal obturation, 12h postoperative, 24h, Day 2, Day 3, Day 7). The maximum pain felt will be compared between the 2 groups.

    To note: the endodontic treatment was performed in 2 sessions for some patients. For those patients, there is an additional pain evaluation done before the session 2.

    Measured: 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.

  5. Use of Oral Pain Treatment

    Patients reported the consumption of analgesic treatment in a diary. The percentage of patients who took oral pain medication will be compared between the 2 groups.

    Measured: From Day 0 to Day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2021
  2. Study start6 Nov 2020
  3. Primary completion29 Aug 2023
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04757753
Sponsor's protocol ID
20/001
Other IDs
2020-A01790-39-PP, CIV-BE-20-10-034945
Acronym
OPTIFILL
Status last verified
May 2026
First submitted
12 Feb 2021
Last updated
8 Jun 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40491343

Questions about this trial

What is this clinical trial studying?

A study testing ready-to-use root canal sealer: PA1704 and root canal sealer: BioRoot™ RCS in people with Root Canal Obturation, run by Septodont at 5 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in France, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy Rate of Root Canal Obturation (time frame: 24 months post-treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04757753, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.

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