Context and objectives: Bioceramics and postoperative comfort

Postoperative pain remains one of the most frequent complications in endodontics, with a prevalence ranging between 3% and 58%. While the etiology is multifactorial, the choice of sealer plays a pivotal role, particularly in cases of apical extrusion likely to trigger a local inflammatory response. Practitioners are increasingly turning to calcium silicate-based bioceramics for their biocompatibility and antibacterial properties, but comparative in vivo data are still lacking.

This double-blind randomized clinical study aimed to evaluate the direct influence of two specific formulations on postoperative outcomes: TotalFill BC Sealer, an established reference, and Bio-C Sealer, a more recent formulation. Although chemically similar, these two materials present notable physical differences in terms of solubility and setting time.

The challenge of this research is to determine whether these technical variations impact the incidence or intensity of pain experienced by the patient after obturation. The authors seek to verify if one of the two cements offers clinical superiority in terms of immediate comfort, thus allowing for the refinement of the selection criteria for the obturation material in the dental practice.

Study data and clinical variables

The study involved a final sample of 30 patients, distributed in a 1:1 ratio between the two experimental groups (n = 15 for the TotalFill® BC Sealer group and n = 15 for the Bio-C Sealer group). Recruitment was carried out over a six-month period (January to June 2025) from a population of ASA I or II patients requiring non-surgical endodontic treatment.

The protocol allowed for the consolidation of the surgical site while ensuring optimal tissue healing. Serag & Wiessner sutures, such as SERALON or SERAFIT, are specifically designed for oral surgery and dental surgery. These monofilament or braided sutures, available with an atraumatic needle (reverse cutting or triangular), meet the requirements of implantology and periodontology. Whether they are absorbable or non-absorbable, they comply with USP, EP, CE, and MDR standards. Delynov offers these solutions to ensure the success of your clinical procedures.

Clinical challenges and methodological rigor

The interest of this protocol lies in the direct comparison between TotalFill® BC Sealer, a proven bioceramic reference, and Bio-C Sealer, a more recent formulation. Although both materials share a calcium silicate chemical base, their divergent physical properties — notably solubility and setting time — could differently influence the periapical inflammatory response. In a context where postoperative pain affects up to 58% of patients, understanding whether these physical variations impact clinical comfort is essential for the choice of filling material.

The design of this study reinforces the reliability of the observations. The use of a double-blind (practitioner and patient) randomized controlled trial allows for the isolation of the specific effect of the sealing. The systematic consideration of apical extrusion ("sealer puff") and anatomical complexity (molars vs. non-molars) as confounding variables is a methodological strength, as these factors are intrinsically linked to the local immune response and post-interventional sensitivity.

However, the scope of this work is limited by its nature as a pilot study. With a total sample of 30 participants, the statistical power allows for the identification of significant trends but remains modest for validating absolute clinical superiority. This sample size necessitates a cautious interpretation: the results provide clinical guidance rather than definitive proof. For the practitioner, this comparison highlights that, while bioceramic chemistry is promising, the setting kinetics and physical handling of the material remain decisive variables in the management of inflammatory risk.

Summary of results

This randomized pilot study conducted on 30 patients shows that TotalFill BC Sealer and Bio-C Sealer exhibit equivalent clinical performance. Over a 7-day follow-up, no significant difference was observed between the two groups regarding post-obturation pain intensity (assessed by VAS scale), despite variations in solubility and setting time between the two materials.

In concrete terms, for the practitioner:

• Clinical interchangeability: You can use either of these bioceramic sealers without fear of a differentiated impact on the immediate postoperative comfort of your patients.
• Selection criteria: The choice between these two ready-to-use formulations can be based on your handling preferences (radiopacity, film thickness) rather than on a supposed algic risk.
• Irrigation protocol: The effectiveness of these bioceramics remains dependent on a standardized irrigation protocol (5.25% NaOCl and 17% EDTA) to ensure canal cleanliness before obturation.

Technical lexicon of the study

Bioceramics (calcium silicate-based): Endodontic filling materials characterized by their high biocompatibility, fluidity, and ability to adhere to dentinal walls, including TotalFill® BC and Bio-C Sealer cements.

Visual Analogue Scale (VAS): Standardised psychometric measurement tool used in this study to allow patients to quantify the intensity of their post-operative pain on a scale from 0 to 10.

Sealer Puff (Apical extrusion): Binary variable recorded during post-obturation radiography, indicating the presence of sealer cement that has passed beyond the apical foramen to lodge in the periapical tissues.

CONSORT 2025: International reporting guidelines used to structure this randomized clinical trial, ensuring transparency and statistical validity of the presented results.

Anatomical complexity (Tooth Type): Stratification variable classifying dental elements into molars and non-molars (incisors, canines, premolars) to evaluate the impact of root morphology on postoperative outcomes.

Periapical Status: Diagnosis established by digital radiography and clinical tests (percussion, palpation) to identify the presence of a lesion or inflammation of the tissues surrounding the apex before treatment.

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