CompletedNot Applicable

Bioactive Materials in Vital Pulp Therapy of Permanent Teeth

Turkey (Türkiye)80 participantsStarted 2025-01-10

Plain-language 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. 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.

Who can participate

Age range

13 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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) * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Clinical and radiographic success of direct pulp capping

Timeframe: 1 year follow-up

Trial details

NCT IDNCT07562555

SponsorEge University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-10

View on ClinicalTrials.gov More Vital Pulp Therapy trials