PainNCT07350746
A Comparison of Outcome of Pulpotomy on Immature Permanent Molars Between Different Calcium Silicate-based Materials : a 12 Months Clinical Study
A study testing Bio-C® Repair (BCR; Angelus, Londrina, Brazil), Total Fill® BC UNIVERSAL RRM™ (FKG Dentaire, Switzerland) and Neo PUTTY (Nusmile Inc, Houston, TX; USA) in people with Pain and Lesions, run by Saint-Joseph University at 1 site in Lebanon.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 7 to 11 years
- What is being tested?
- Bio-C® Repair (BCR; Angelus, Londrina, Brazil), Total Fill® BC UNIVERSAL RRM™ (FKG Dentaire, Switzerland) and Neo PUTTY (Nusmile Inc, Houston, TX; USA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteLebanon
- Study dates
- 1 Oct 2025to 27 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- -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.
Show all 9Show fewer
- 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).
Who cannot join
- -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.
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
About this 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.
- Being tested
- Bio-C® Repair (BCR; Angelus, Londrina, Brazil), Total Fill® BC UNIVERSAL RRM™ (FKG Dentaire, Switzerland), Neo PUTTY (Nusmile Inc, Houston, TX; USA)
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Neo PUTTY (Nusmile Inc, Houston, TX; USA) | Experimental | premixed bioactive bioceramic composed of an inorganic powder containing tricalcium and dicalcium silicate in a water-free organic liquid. Receives: Device: Neo PUTTY (Nusmile Inc, Houston, TX; USA) |
| Total Fill® BC UNIVERSAL RRM™ (FKG Dentaire, Switzerland) | Active comparator | premixed bioceramic material composed of calcium aluminosilicate paste designed for permanent root canal repair and surgical applications. Receives: Device: Total Fill® BC UNIVERSAL RRM™ (FKG Dentaire, Switzerland) |
| Bio-C® Repair (BCR; Angelus, Londrina, Brazil) | Active comparator | 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. Receives: Device: Bio-C® Repair (BCR; Angelus, Londrina, Brazil) |
What is being measured
The primary outcome is the main question the study is designed to answer.
-Root formation and apical closure.
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
Measured: 12 months
-Postoperative pain. -Percussion and/or palpation pain.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start1 Oct 2025
- Primary completion27 Feb 2027 (estimated)
- Study completion27 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saint-Joseph University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07350746
- Sponsor's protocol ID
- USJ- CER-2025-289
- Status last verified
- Jan 2026
- First submitted
- 29 Nov 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Outcome of Pulpotomy on Immature Permanent Molars Between Different Calcium Silicate-based Materials : a 12 Months Clinical Study
- ClinicalTrials.gov ID
- NCT07350746
- Acronym / sponsor ID
- USJ- CER-2025-289
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Saint-Joseph UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 27 Feb 2027 (estimated)
- Study completion
- 27 Feb 2027 (estimated)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Neo PUTTY (Nusmile Inc, Houston, TX; USA) | Experimental | Device: Neo PUTTY (Nusmile Inc, Houston, TX; USA)premixed bioactive bioceramic composed of an inorganic powder containing tricalcium and dicalcium silicate in a water-free organic liquid. |
| Total Fill® BC UNIVERSAL RRM™ (FKG Dentaire, Switzerland) | Active comparator | Device: Total Fill® BC UNIVERSAL RRM™ (FKG Dentaire, Switzerland)premixed bioceramic material composed of calcium aluminosilicate paste designed for permanent root canal repair and surgical applications. |
| Bio-C® Repair (BCR; Angelus, Londrina, Brazil) | Active comparator | Device: Bio-C® Repair (BCR; Angelus, Londrina, Brazil)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. |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- -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.
Key exclusion criteria (10 listed)
- -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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bio-C® Repair (BCR; Angelus, Londrina, Brazil)To the best of our knowledge, no study has yet compared these three biomaterials in the treatment of permanent molars with incomplete root development. | Device | Bio-C® Repair (BCR; Angelus, Londrina, Brazil) |
| Total Fill® BC UNIVERSAL RRM™ (FKG Dentaire, Switzerland)To the best of our knowledge, no study has yet compared these three biomaterials in the treatment of permanent molars with incomplete root development. | Device | Total Fill® BC UNIVERSAL RRM™ (FKG Dentaire, Switzerland) |
| Neo PUTTY (Nusmile Inc, Houston, TX; USA)To the best of our knowledge, no study has yet compared these three biomaterials in the treatment of permanent molars with incomplete root development. | Device | Neo PUTTY (Nusmile Inc, Houston, TX; USA) |
Primary outcome
-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
-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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bio-C® Repair (BCR; Angelus, Londrina, Brazil), Total Fill® BC UNIVERSAL RRM™ (FKG Dentaire, Switzerland) and Neo PUTTY (Nusmile Inc, Houston, TX; USA) in people with Pain and Lesions, run by Saint-Joseph University at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
-Root formation and apical closure. (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.