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Bioactive Materials in Vital Pulp Therapy of Permanent Teeth

25. dubna 2026 aktualizováno: Gözde Kandemir Demirci, Ege University

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.

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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Aktuální)

80

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě
  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ano

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Aktivní komparátor: ProRoot MTA
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.
Postup: Direct pulp capping with ProRoot MTA
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.
Experimentální: BIOfactor MTA
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.
Postup: Direct pulp capping with BIOfactor MTA
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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Clinical and radiographic success of direct pulp capping
Časové okno: 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 year follow-up

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Postoperative pain intensity following direct pulp capping
Časové okno: up to 2-day
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.
up to 2-day

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Ege University

Vyšetřovatelé

  • Vrchní vyšetřovatel: Gözde Kandemir Demirci, Associate Professor, Ege University Faculty of Dentistry

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

10. ledna 2025

Primární dokončení (Aktuální)

10. dubna 2026

Dokončení studie (Aktuální)

10. dubna 2026

Termíny zápisu do studia

První předloženo

25. dubna 2026

První předloženo, které splnilo kritéria kontroly kvality

25. dubna 2026

První zveřejněno (Aktuální)

1. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

1. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

25. dubna 2026

Naposledy ověřeno

1. dubna 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 24-3.1/5
  • 32695 (Jiné číslo grantu/financování: Ege University Scientific Research Projects Coordination Unit (BAP))

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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Klinické studie na Direct pulp capping with ProRoot MTA

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Podmínky

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