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NCT Number: NCT07350746

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

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.

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Key information

Conditions

Pain Lesions Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

7 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universite Saint Joseph de Beyrouth

Beirut, Lebanon

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Device

To the best of our knowledge, no study has yet compared these three biomaterials in the treatment of permanent molars with incomplete root development.

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

Device

To the best of our knowledge, no study has yet compared these three biomaterials in the treatment of permanent molars with incomplete root development.

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

Device

To the best of our knowledge, no study has yet compared these three biomaterials in the treatment of permanent molars with incomplete root development.

Primary outcomes

  1. -Root formation and apical closure.

    Time frame: 12 months

    Continued root formation and apical closure will be assessed using standardized periapical radiographs of the treated immature permanent molars and classified according to Cvek's stages of root development. Radiographic evaluation will be performed by a calibrated examiner. Progression in root development will be determined by changes in root length and apical foramen morphology compared with baseline.

    Cvek's classification includes five radiographic stages of root development:

    Stage I (A): < 1/2 root length

    Stage II (B): 1/2 root length

    Stage III (C): 2/3 root length

    Stage IV (D): Nearly complete root length with wide open apical foramen

    Stage V (E): Complete root development with closed apical foramen

  2. -Postoperative pain. -Percussion and/or palpation pain.

    Time frame: 12 months

    Pain response will be recorded as a binary outcome (Yes/No) based on the patient's subjective report during standardized clinical examination. The assessment will be performed by a calibrated examiner using gentle vertical percussion and periapical palpation according to routine endodontic diagnostic procedures.

    Measurement Tool

    Clinical percussion test

    Clinical palpation test

    Patient-reported pain response during examination (verbal report) Postoperative pain assessed using a Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst pain imaginable), recorded by the patient.

Other outcomes

  1. -Presence of periapical lesion.

    Time frame: 12 months

    Presence of periapical lesion assessed on standardized periapical radiographs using the Periapical Index (PAI); lesions defined as a PAI score ≥ 3.

Sponsors and collaborators

Lead sponsor

Saint-Joseph University

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 20, 2026
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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