NCT04757753

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Septodont · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Root Canal Obturation

Interventions

Type	Name	Description
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.
DEVICE	root canal sealer: BioRoot™ RCS	The participant will be treated with BioRoot™ RCS sealer in combination with gutta percha.

Timeline

• Start date: 2020-11-06
• Primary completion: 2023-08-29
• Completion: 2026-07-01
• First posted: 2021-02-17
• Last updated: 2025-06-26
• Results posted: 2024-10-10

Locations

5 sites across 2 countries: Belgium, France