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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Root Canal Obturation
• Intervention / Treatment: Device: ready-to-use root canal sealer: PA1704; Device: root canal sealer: BioRoot™ RCS

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles, Belgium, 1200
    • Cliniques Universitaires Saint-Luc, Département de Médecine Dentaire et de Stomatologie
• France
  • Paris, France, 75019
    • Centre de santé dentaire Flandre
  • Rennes, France, 35000
    • Cabinet dentaire
  • Rouen, France, 76000
    • Cabinet dentaire Jeanne d'Arc
  • Saint-Grégoire, France, 35760
    • Cabinet dentaire

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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
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
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.
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
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

Collaborators and Investigators

• Sponsor: Septodont
• Collaborators: Slb Pharma
• Investigators: Principal Investigator: Stéphane Simon, Pr, DDS, Cabinet dentaire Jeanne d'Arc - ROUEN (76000) - France

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2020
• Primary Completion (Actual): August 29, 2023
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: February 12, 2021
• First Submitted That Met QC Criteria: February 12, 2021
• First Posted (Actual): February 17, 2021

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: endodontic treatment; root canal sealer; periapical lesion
• Other Study ID Numbers: 20/001; 2020-A01790-39-PP (Other Identifier: French National Agency of Medicines and Health products); CIV-BE-20-10-034945 (Other Identifier: Belgium Federal Agency for Medicines and Health products)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No