New tooth filler could simplify root canals
NCT ID NCT04757753
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new ready-to-use root canal sealer (PA1704) against a standard sealer (BioRoot RCS) in 160 adults needing root canal treatment. The goal is to see if the new sealer works as well or better at keeping the tooth healthy and free of infection for up to 2 years. Participants will have follow-up visits at 6, 12, and 24 months to check the tooth's condition with X-rays and exams.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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160 people
The number who actually took part.
- Started
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Nov 2020
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Cabinet dentaire
Rennes, 35000, France
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Cabinet dentaire
Saint-Grégoire, 35760, France
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Cabinet dentaire Jeanne d'Arc
Rouen, 76000, France
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Centre de santé dentaire Flandre
Paris, 75019, France
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Cliniques Universitaires Saint-Luc, Département de Médecine Dentaire et de Stomatologie
Brussels, 1200, Belgium
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