Vital Pulp TherapyNCT07562555
Bioactive Materials in Vital Pulp Therapy of Permanent Teeth
A study testing Direct pulp capping with ProRoot MTA and Direct pulp capping with BIOfactor MTA in people with Vital Pulp Therapy, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
This randomized clinical study aimed to evaluate and compare the clinical, radiographic, and postoperative pain outcomes of direct pulp capping performed using two calcium silicate-based materials: ProRoot MTA and Biofactor MTA in permanent teeth with vital pulp exposure. Read more about this study
- Who is it for?
- Ages 13 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Vital Pulp Therapy
- What is being tested?
- Direct pulp capping with ProRoot MTA and Direct pulp capping with BIOfactor MTA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2025to 10 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 13 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients aged between 13 and 65 years
- Patients with adequate patient-clinician communication
- Patients who agree to attend periodic follow-up visits throughout the study
- Patients who provide written informed consent to participate in the study
- Systemically healthy patients
- Teeth with no previous endodontic treatment
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- Teeth showing a positive response to cold and electric pulp test
- Permanent teeth
- Posterior teeth
- Teeth that can be restored with direct composite restoration
- Teeth with pulp exposure (pulpal perforation)
- Presence of bleeding from the exposed pulp that can be controlled within 5-10 minutes
Who cannot join
- Patients who refuse to participate in the study
- Medically compromised patients (e.g., patients with systemic diseases, immunological disorders, or those using medications)
- Patients with known allergies to materials used during vital pulp therapy
- Pregnant patients
- Non-vital teeth
- Presence of advanced periodontal disease (probing depth > 3 mm)
Show all 13Show fewer
- Teeth with previous endodontic treatment
- Teeth with insufficient remaining tooth structure that cannot be restored with restorative materials
- Teeth where adequate isolation cannot be achieved
- Teeth requiring post core restoration
- Patients in whom periapical radiographs cannot be obtained
- Patients unable to attend follow-up visits
- Cases in which bleeding from the exposed pulp cannot be controlled within 5-10 minutes
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University Faculty of Dentistry
Izmir, 35100
About this study
Official title: Evaluation of the Effect of Two Different Bioactive Materials on the Success of Vital Pulp Therapy in Permanent Teeth: A Prospective Clinical Study
This randomized clinical study aimed to evaluate and compare the clinical, radiographic, and postoperative pain outcomes of direct pulp capping performed using two calcium silicate-based materials: ProRoot MTA and Biofactor MTA in permanent teeth with vital pulp exposure.
A total of 80 teeth were randomly allocated into two groups according to the capping material used. Following standardized caries removal and achievement of hemostasis, direct pulp capping was performed using either ProRoot MTA or Biofactor MTA under similar clinical conditions. Definitive coronal restorations were completed 24 hours after the procedure.
Read more
Postoperative pain was assessed using a numerical rating scale (NRS) at 0, 6, 12, 24, and 48 hours after treatment. Patients were instructed to record their pain levels and analgesic intake during this period.
Patients were recalled for clinical and radiographic evaluations at 6 and 12 months. Clinical success was defined as the absence of spontaneous pain, sensitivity, swelling, sinus tract formation, and tenderness to percussion or palpation. Radiographic success was determined by the absence of periapical pathology.
Additionally, the influence of demographic and clinical variables, including age, gender, characteristics of pulp exposure, and intraoperative factors, on treatment outcomes and pulpal healing was evaluated.
Read the detailed description
This randomized controlled clinical study was designed to evaluate and compare the clinical performance, radiographic outcomes, postoperative pain, and pulpal healing following direct pulp capping using two calcium silicate-based materials: ProRoot MTA and Biofactor MTA in permanent teeth with vital pulp exposure.
A total of 80 teeth diagnosed with vital pulp requiring direct pulp capping were included in the study. Participants were randomly allocated into two equal groups (n=40) according to the pulp capping material used. All procedures were carried out under standardized clinical conditions.
Caries removal was performed using a sterile round diamond bur under water cooling, followed by excavation with a spoon excavator. Teeth with pulp exposure were included in the study. Hemostasis was achieved. In cases where bleeding could not be controlled within a clinically acceptable time, the tooth was excluded from the study.
In the experimental group, Biofactor MTA was applied directly over the exposed pulp tissue according to the manufacturer's instructions. In the control group, ProRoot MTA was used following the same protocol. After placement of the capping material, a protective base was applied, and the cavity was temporarily restored. Definitive coronal restorations were completed 24 hours after the initial procedure.
Postoperative pain was evaluated using a Numerical Rating Scale (NRS) at 0, 6, 12, 24, and 48 hours following treatment. Patients were instructed to record their pain intensity and the number of analgesic tablets taken during this period.
Patients were recalled for follow-up examinations at 6 and 12 months. Clinical evaluation included assessment of spontaneous pain, sensitivity, swelling, sinus tract formation, tenderness to percussion and palpation, and periodontal probing depths. Radiographic evaluation was performed to assess the presence of periapical pathology.
Treatment success was defined as the absence of clinical symptoms and the absence of radiographic signs of pathology.
Furthermore, the influence of demographic and clinical variables, including age, gender, number and location of pulp exposures, size of exposure, and bleeding control time, on treatment outcomes was analyzed.
- Conditions
- Vital Pulp Therapy
- Being tested
- Direct pulp capping with ProRoot MTA, Direct pulp capping with BIOfactor MTA
- Keywords
- dental pulp, bioactive material, direct pulp capping, endodontics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct pulp capping with ProRoot MTAProcedure or surgery
Direct pulp capping was performed using ProRoot MTA after caries removal and hemostasis. The material was placed over the pulp exposure, and definitive restoration was completed after 24 hours.
Direct pulp capping with BIOfactor MTAProcedure or surgery
Direct pulp capping was performed using Biofactor MTA following caries removal and hemostasis. The material was applied directly over the exposed pulp, and definitive restoration was completed after 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| ProRoot MTA | Active comparator | In this group, direct pulp capping procedures were performed using ProRoot MTA. Following caries removal under water cooling with a sterile round diamond bur and spoon excavator, teeth with pulp exposure were included in the study. Hemostasis was achieved. ProRoot MTA was then placed directly over the exposed pulp tissue according to the manufacturer's instructions. A protective base was applied over the material, and the cavity was temporarily restored. Definitive coronal restoration was completed 24 hours after the procedure. Receives: Procedure: Direct pulp capping with ProRoot MTA |
| BIOfactor MTA | Experimental | In this group, direct pulp capping procedures were performed using BIOfactor MTA. Following caries removal under water cooling with a sterile round diamond bur and spoon excavator, teeth with pulp exposure were included in the study. Hemostasis was achieved. BIOfactor MTA was placed over the exposure site in accordance with the manufacturer's recommendations. A protective base material was applied, and temporary restoration was performed. Permanent coronal restoration was completed 24 hours later. Receives: Procedure: Direct pulp capping with BIOfactor MTA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical and radiographic success of direct pulp capping
Treatment success defined as the absence of clinical symptoms, including spontaneous pain, sensitivity, swelling, sinus tract formation, and tenderness to percussion or palpation, together with the absence of radiographic signs of pathology such as periapical radiolucency.
Measured: 1 year follow-up
Secondary outcomes (1)
Postoperative pain intensity following direct pulp capping
Postoperative pain will be evaluated using a Numerical Rating Scale (NRS), where patients rate their pain intensity at predefined time intervals after treatment. The Numerical Rating Scale is a pain measurement scale that encompasses the following grades: 0 no pain, 1-3 mild pain, 4-6 moderate pain, 7-10 severe pain. Patients will be instructed to record their pain levels and analgesic intake.
Measured: up to 2-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start10 Jan 2025
- Primary completion10 Apr 2026
- Study completion10 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vital Pulp TherapyStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gözde Kandemir Demirci, Ege University
- Investigators
- Gözde Kandemir Demirci, Associate Professor, Principal investigator, Ege University Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07562555
- Sponsor's protocol ID
- 24-3.1/5
- Other IDs
- 32695
- Status last verified
- Apr 2026
- First submitted
- 25 Apr 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Two Different Bioactive Materials on the Success of Vital Pulp Therapy in Permanent Teeth: A Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT07562555
- Acronym / sponsor ID
- 24-3.1/5
- Conditions
- Vital Pulp Therapy
- Keywords
- dental pulp, bioactive material, direct pulp capping, endodontics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 10 Apr 2026 (actual)
- Study completion
- 10 Apr 2026 (actual)
- First posted
- 1 May 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.
This randomized clinical study aimed to evaluate and compare the clinical, radiographic, and postoperative pain outcomes of direct pulp capping performed using two calcium silicate-based materials: ProRoot MTA and Biofactor MTA in permanent teeth with vital pulp exposure.
A total of 80 teeth were randomly allocated into two groups according to the capping material used. Following standardized caries removal and achievement of hemostasis, direct pulp capping was performed using either ProRoot MTA or Biofactor MTA under similar clinical conditions. Definitive coronal restorations were completed 24 hours after the procedure.
Postoperative pain was assessed using a numerical rating scale (NRS) at 0, 6, 12, 24, and 48 hours after treatment. Patients were instructed to record their pain levels and analgesic intake during this period.
Patients were recalled for clinical and radiographic evaluations at 6 and 12 months. Clinical success was defined as the absence of spontaneous pain, sensitivity, swelling, sinus tract formation, and tenderness to percussion or palpation. Radiographic success was determined by the absence of periapical pathology.
Additionally, the influence of demographic and clinical variables, including age, gender, characteristics of pulp exposure, and intraoperative factors, on treatment outcomes and pulpal healing was evaluated.
Detailed description
This randomized controlled clinical study was designed to evaluate and compare the clinical performance, radiographic outcomes, postoperative pain, and pulpal healing following direct pulp capping using two calcium silicate-based materials: ProRoot MTA and Biofactor MTA in permanent teeth with vital pulp exposure.
A total of 80 teeth diagnosed with vital pulp requiring direct pulp capping were included in the study. Participants were randomly allocated into two equal groups (n=40) according to the pulp capping material used. All procedures were carried out under standardized clinical conditions.
Caries removal was performed using a sterile round diamond bur under water cooling, followed by excavation with a spoon excavator. Teeth with pulp exposure were included in the study. Hemostasis was achieved. In cases where bleeding could not be controlled within a clinically acceptable time, the tooth was excluded from the study.
In the experimental group, Biofactor MTA was applied directly over the exposed pulp tissue according to the manufacturer's instructions. In the control group, ProRoot MTA was used following the same protocol. After placement of the capping material, a protective base was applied, and the cavity was temporarily restored. Definitive coronal restorations were completed 24 hours after the initial procedure.
Postoperative pain was evaluated using a Numerical Rating Scale (NRS) at 0, 6, 12, 24, and 48 hours following treatment. Patients were instructed to record their pain intensity and the number of analgesic tablets taken during this period.
Patients were recalled for follow-up examinations at 6 and 12 months. Clinical evaluation included assessment of spontaneous pain, sensitivity, swelling, sinus tract formation, tenderness to percussion and palpation, and periodontal probing depths. Radiographic evaluation was performed to assess the presence of periapical pathology.
Treatment success was defined as the absence of clinical symptoms and the absence of radiographic signs of pathology.
Furthermore, the influence of demographic and clinical variables, including age, gender, number and location of pulp exposures, size of exposure, and bleeding control time, on treatment outcomes was analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ProRoot MTA | Active comparator | Procedure: Direct pulp capping with ProRoot MTAIn this group, direct pulp capping procedures were performed using ProRoot MTA. Following caries removal under water cooling with a sterile round diamond bur and spoon excavator, teeth with pulp exposure were included in the study. Hemostasis was achieved. ProRoot MTA was then placed directly over the exposed pulp tissue according to the manufacturer's instructions. A protective base was applied over the material, and the cavity was temporarily restored. Definitive coronal restoration was completed 24 hours after the procedure. |
| BIOfactor MTA | Experimental | Procedure: Direct pulp capping with BIOfactor MTAIn this group, direct pulp capping procedures were performed using BIOfactor MTA. Following caries removal under water cooling with a sterile round diamond bur and spoon excavator, teeth with pulp exposure were included in the study. Hemostasis was achieved. BIOfactor MTA was placed over the exposure site in accordance with the manufacturer's recommendations. A protective base material was applied, and temporary restoration was performed. Permanent coronal restoration was completed 24 hours later. |
Who may qualify
- Ages
- 13 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Patients aged between 13 and 65 years
- Patients with adequate patient-clinician communication
- Patients who agree to attend periodic follow-up visits throughout the study
- Patients who provide written informed consent to participate in the study
- Systemically healthy patients
Key exclusion criteria (13 listed)
- Patients who refuse to participate in the study
- Medically compromised patients (e.g., patients with systemic diseases, immunological disorders, or those using medications)
- Patients with known allergies to materials used during vital pulp therapy
- Pregnant patients
- Non-vital teeth
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 |
|---|---|---|
| Direct pulp capping with ProRoot MTADirect pulp capping was performed using ProRoot MTA after caries removal and hemostasis. The material was placed over the pulp exposure, and definitive restoration was completed after 24 hours. | Procedure or surgery | ProRoot MTA |
| Direct pulp capping with BIOfactor MTADirect pulp capping was performed using Biofactor MTA following caries removal and hemostasis. The material was applied directly over the exposed pulp, and definitive restoration was completed after 24 hours. | Procedure or surgery | BIOfactor MTA |
Primary outcome
Clinical and radiographic success of direct pulp capping
Time frame: 1 year follow-up
Treatment success defined as the absence of clinical symptoms, including spontaneous pain, sensitivity, swelling, sinus tract formation, and tenderness to percussion or palpation, together with the absence of radiographic signs of pathology such as periapical radiolucency.
1 secondary outcome
Postoperative pain intensity following direct pulp capping
Time frame: up to 2-day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No
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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.
Gözde Kandemir Demirci, Associate Professor principal investigator
Ege University Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Direct pulp capping with ProRoot MTA and Direct pulp capping with BIOfactor MTA in people with Vital Pulp Therapy, run by Ege University at 1 site in Turkey (Türkiye).
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 12 inclusion and 13 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: finished, as of the sponsor's last update on 1 May 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical and radiographic success of direct pulp capping (time frame: 1 year follow-up). 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 1 May 2026.