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

Study Overview
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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.

Official Title
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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

Conditions
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Root Canal Obturation

Intervention / Treatment
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* Device: ready-to-use root canal sealer: PA1704
* Device: root canal sealer: BioRoot™ RCS


Participation Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ready-to-use root canal sealer: PA1704<br>PA1704 is used in combination with gutta percha points for the permanent obturation of root canals. | Device: ready-to-use root canal sealer: PA1704<br>* The participant will be treated with the ready-to-use root canal sealer (PA1704) in combination with gutta percha.<br>|
| Other: root canal sealer: BioRoot™ RCS<br>BioRoot™ RCS is used in combination with gutta percha points for the permanent obturation of root canals. | Device: root canal sealer: BioRoot™ RCS<br>* The participant will be treated with BioRoot™ RCS sealer in combination with gutta percha.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy rate of root canal obturation | Efficacy rate of root canal obturation using clinical and radiological criteria. The radiographic criterion will be assessed by blinded evaluators. The efficacy rates will be compared between the 2 groups. | 24 months post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy rate of root canal obturation | Efficacy rate of root canal obturation using clinical and radiological criteria. The radiographic criterion will be assessed by blinded evaluators. The efficacy rates will be compared between the 2 groups at 6 and 12-months post-treatment. The efficacy rate after 3.5 and 5 years will measured only in the PA1704 group. | 6-, 12-months, 3.5 and 5 years post-treatment | 
| Radiological evaluation of the canal obturation | Radiological evaluation of the level of apical obturation and density | baseline, 6-, 12-, 24-months, 3.5 and 5 years post-treatment | 
| Postoperative pain | The pain is assessed by patients in a diary using a Visual Analogue Scale (VAS: 0-100 mm) 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. | from the end of the root canal treatment (Day 0) to Day 7. | 
| Use of oral pain treatment | Patients reported the consumption of analgesic treatment in a diary. The proportion of patients who took oral pain medication and the treatment categories will be compared between the 2 groups. | from the end of the root canal treatment (Day 0) to Day 7 | 
| Adverse events | Adverse events reported by patients on a diary from Day 0 to Day 7 and adverse events clinically observed by the dental surgeon at each follow-up visit will be used to assess the safety of root canal sealers and endodontic procedures | from the end of the root canal treatment (Day 0) to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endodontic treatment, root canal sealer, periapical lesion