A Comparison of Outcome of Pulpotomy on Immature Permanent Molars Between Different Calcium Silicate-based Materials : a 12 Months Clinical Study

Saint-Joseph University

Status: Active, not recruiting

Conditions: Pain; Lesions

Treatments: Device: Bio-C® Repair (BCR; Angelus, Londrina, Brazil); Device: Total Fill® BC UNIVERSAL RRM™ (FKG Dentaire, Switzerland); Device: Neo PUTTY (Nusmile Inc, Houston, TX; USA)

Study type: Interventional

Funder types: Other

Identifiers

NCT07350746

USJ- CER-2025-289

Details and patient eligibility

About

Preservation of pulp vitality through vital pulp therapy (VPT) has emerged in contemporary endodontics, particularly for immature permanent teeth. In cases of irreversible pulpitis, recent literature suggests that clinical symptoms do not always correlate with histopathological findings, supporting the use of conservative approaches such as full pulpotomy. This is especially relevant in young patients where continued root development and apical closure are critical for long-term tooth integrity and functionality. Immature teeth, due to their high cellularity and vascularity, exhibit a greater regenerative capacity, making them indicated for biologically based treatments.

Among the materials used for VPT, calcium silicate-based cements (CSCs) have demonstrated good biological and physicochemical properties, including high biocompatibility, antimicrobial effects, alkaline pH, and sustained release of calcium ions that stimulate biomineralization. Mineral Trioxide Aggregate (MTA) has long been considered the gold standard; however, it is associated with several clinical limitations such as extended setting time, complex handling, and potential tooth discoloration. To address these drawbacks, newer generation premixed bioceramics have been introduced. These include NeoPUTTY®, Total Fill® BC UNIVERSAL RRM™, and Bio-C® Repair, each exhibiting unique compositional and functional properties designed to enhance clinical performance and ease of use.

Despite promising individual results, no clinical study has yet compared these three materials within the context of pulpotomy in immature permanent molars with irreversible pulpitis. This randomized clinical trial aims to fill this gap by evaluating their clinical and radiographic outcomes over a 12-month period, to better guide material selection in vital pulp therapy.

Enrollment: 48 estimated patients

Sex: All

Ages: 7 to 11 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• -Healthy patients (according to ASA classification) with noncontributory medical history.
• Patients aged between 7 and 11 years of age, with at least one immature permanent molar with deep caries, needing full pulpotomy.
• Cooperative pediatric patients (Frankl's behavioral rating scale).
• Restorable immature permanent molar with deep caries: caries involving the pulpal roof or where complete caries removal would likely result in pulpal exposure.
• Physiological mobility.
• Vital pulp (detected by clinical signs/symptoms) presenting symptoms classically indicative of irreversible pulpitis according to AAE diagnostic criteria : positive but heightened response to cold sensibility testing, presence of spontaneous pain.
• No clinical signs of pulp necrosis; absence of a sinus tract or swelling.
• Patients who agree to return for periodic examination (follow-up).
• Patients who are willing to sign the consent form (written informed consent).

Exclusion criteria

• -Medically compromised patients.
• Patients older than 11 years or younger than 7 years of age.
• Mature permanent molar.
• No signs and symptoms of irreversible pulpitis.
• No pulp exposure even after complete caries excavation.
• Clinical signs of pulp necrosis on the tooth to be treated, such as insufficient bleeding or no bleeding after pulp exposure.
• Uncontrollable pulp hemorrhage (more than 10 minutes of hemostasis).
• Teeth previously endodontically treated.
• Teeth with pathological root resorption.
• Impossibility to place a rubber dam.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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48 participants in 3 patient groups

Neo PUTTY (Nusmile Inc, Houston, TX; USA)

Experimental group

Description:

premixed bioactive bioceramic composed of an inorganic powder containing tricalcium and dicalcium silicate in a water-free organic liquid.

Treatment:

Device: Neo PUTTY (Nusmile Inc, Houston, TX; USA)

Total Fill® BC UNIVERSAL RRM™ (FKG Dentaire, Switzerland)

Active Comparator group

Description:

premixed bioceramic material composed of calcium aluminosilicate paste designed for permanent root canal repair and surgical applications.

Treatment:

Device: Total Fill® BC UNIVERSAL RRM™ (FKG Dentaire, Switzerland)

Bio-C® Repair (BCR; Angelus, Londrina, Brazil)

Active Comparator group

Description:

new ready-to-use bioceramic repair material. Bio-C has indications similar to MTA and is composed of calcium silicates \[tricalcium silicate, dicalcium silicate\], tricalcium aluminate, calcium oxide (for the release of calcium ions), and zirconium oxide as a radioopacifier.

Treatment:

Device: Bio-C® Repair (BCR; Angelus, Londrina, Brazil)