Clinical trial NCT04757753: Root Canal Obturation With a Ready-to-use Root Canal Sealer (PA1704) Versus BioRoot™ RCS: a Randomized Controlled Trial
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Root Canal Obturation
Keywords: endodontic treatment
root canal sealer
periapical lesion
Lead sponsor: Septodont
Sponsor class: INDUSTRY
Collaborators: name: Slb Pharma
First posted: 2021-02-17
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Efficacy Rate of Root Canal Obturation
timeFrame: 24 months post-treatment
Secondary outcomes:
measure: Efficacy Rate of Root Canal Obturation
timeFrame: 12 months post-treatment
measure: Efficacy Rate of Root Canal Obturation
timeFrame: 6 months post-treatment
measure: Radiological Evaluation of the Canal Obturation
timeFrame: 24-months post-treatment
measure: Postoperative Pain
timeFrame: 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.
measure: Use of Oral Pain Treatment
timeFrame: From Day 0 to Day 7
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc, Département de Médecine Dentaire et de Stomatologie
city: Paris
country: France
facility: Centre de santé dentaire Flandre
city: Rennes
country: France
facility: Cabinet dentaire
city: Rouen
country: France
facility: Cabinet dentaire Jeanne d'Arc
city: Saint-Grégoire
country: France
facility: Cabinet dentaire
Study officials:
affiliation: Cabinet dentaire Jeanne d'Arc - ROUEN (76000) - France
name: Stéphane Simon, Pr, DDS
role: PRINCIPAL_INVESTIGATOR
References: