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 range13 Years – 65 Years

SexALL

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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

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