TheraCal Materials Versus MTA in Full Pulpotomy
22 juni 2026 bijgewerkt door: Kübra Gürler, Cukurova University
Can TheraCal LC and TheraCal PT Match MTA in Full Pulpotomy? A Twelve-Month Randomized Clinical Trial in Permanent Molars With Symptomatic Irreversible Pulpitis
The goal of this randomized clinical trial is to compare the clinical performance of three pulp capping materials used in full pulpotomy procedures in mature mandibular molars with symptomatic irreversible pulpitis.
The main questions it aims to answer are:
- Does full pulpotomy using mineral trioxide aggregate (MTA) provide favorable postoperative pain control and 12-month clinical success?
- Does full pulpotomy using TheraCal LC provide comparable postoperative pain control and 12-month clinical success to MTA?
- Does full pulpotomy using TheraCal PT provide comparable postoperative pain control and 12-month clinical success to MTA?
Participants will undergo full pulpotomy treatment in mandibular first or second molars diagnosed with symptomatic irreversible pulpitis. After removal of the coronal pulp tissue and achievement of hemostasis, teeth will be randomly assigned to one of three treatment groups.
In the MTA group, the exposed radicular pulp tissue will be covered with mineral trioxide aggregate.
In the TheraCal LC group, the exposed radicular pulp tissue will be covered with light-cured resin-modified calcium silicate material.
In the TheraCal PT group, the exposed radicular pulp tissue will be covered with dual-cured resin-modified calcium silicate material.
Postoperative pain intensity, analgesic intake, and 12-month clinical outcomes will be compared among the three groups.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
72
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
Sarıçam
-
Adana, Sarıçam, Turkije (Türkiye), 01250
- Cukurova University
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
Inclusion Criteria:
- Patients requiring full pulpotomy treatment in mandibular first or second permanent molars diagnosed with symptomatic irreversible pulpitis.
- Mandibular first or second permanent molars with a preoperative Visual Analogue Scale (VAS) pain score ≥4, indicating moderate or severe pain.
- Vital mandibular first or second permanent molars showing positive responses to both cold and electric pulp tests.
- Teeth with deep carious lesions indicated for vital pulp therapy.
- Teeth with no radiographic evidence of periapical pathology.
- Patients who had not taken analgesics or antibiotics within the 24 hours preceding the procedure.
Exclusion Criteria:
- Non-vital mandibular permanent molars showing negative responses to cold or electric pulp tests.
- Non-restorable teeth.
- Teeth with root caries, open apex, pulp calcification, internal or external resorption, or periodontal involvement.
- Mandibular first or second permanent molars with poor periodontal status, defined as periodontal pocket depth >4 mm.
- Teeth with radiographic evidence of periapical pathology.
- Patients with systemic conditions such as uncontrolled hypertension, uncontrolled diabetes mellitus, chronic kidney disease, hematological disorders, or a history of chemotherapy or radiotherapy.
- Patients with contraindications to full pulpotomy treatment or local anesthesia.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Fundamentele wetenschap
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: MTA Group
After removal of the coronal pulp tissue and achievement of hemostasis, the exposed radicular pulp tissue was covered with mineral trioxide aggregate (MTA).
The material was placed over the pulp surface at a thickness of approximately 2-4 mm and gently condensed.
A moist sterile cotton pellet was then placed over the material for approximately 10 minutes to allow initial setting.
The tooth was subsequently restored using a standardized restorative protocol.
|
In the MTA group, after full pulpotomy and achievement of hemostasis, the exposed radicular pulp tissue was covered with mineral trioxide aggregate.
The material was placed over the pulp surface at a thickness of approximately 2-4 mm and gently condensed.
|
|
Experimenteel: TheraCal LC Group
After removal of the coronal pulp tissue and achievement of hemostasis, the exposed radicular pulp tissue was covered with TheraCal LC, a light-cured resin-modified calcium silicate material.
The material was applied in increments not exceeding 1 mm to ensure adequate polymerization.
Each increment was light-cured for 20 seconds, and the total material thickness was approximately 2-3 mm.
The tooth was subsequently restored using a standardized restorative protocol.
|
In the TheraCal LC group, after full pulpotomy and achievement of hemostasis, the exposed radicular pulp tissue was covered with TheraCal LC, a light-cured resin-modified calcium silicate material.
The material was applied in increments not exceeding 1 mm, and each increment was light-cured for 20 seconds.
|
|
Experimenteel: TheraCal PT Group
After removal of the coronal pulp tissue and achievement of hemostasis, the exposed radicular pulp tissue was covered with TheraCal PT, a dual-cured resin-modified calcium silicate material.
The material was applied as a single layer at a thickness of approximately 2-3 mm and light-cured for 20 seconds using an LED curing unit.
The tooth was subsequently restored using a standardized restorative protocol.
|
In the TheraCal PT group, after full pulpotomy and achievement of hemostasis, the exposed radicular pulp tissue was covered with TheraCal PT, a dual-cured resin-modified calcium silicate material.
The material was applied as a single layer at a thickness of approximately 2-3 mm and light-cured for 20 seconds.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Postoperative Pain Intensity Assessed by Visual Analogue Scale
Tijdsspanne: Preoperative baseline, 24 hours, 72 hours, 7 days, and 14 days after treatment
|
Postoperative pain intensity will be assessed using a Visual Analogue Scale (VAS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable.
Participants will record their pain intensity at predetermined postoperative time points after full pulpotomy treatment.
VAS scores will be compared among the MTA, TheraCal LC, and TheraCal PT groups.
|
Preoperative baseline, 24 hours, 72 hours, 7 days, and 14 days after treatment
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Koray Yılmaz, DDS, MSc, Professor, Cukurova University
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
16 december 2024
Primaire voltooiing (Werkelijk)
18 juni 2025
Studie voltooiing (Werkelijk)
6 april 2026
Studieregistratiedata
Eerst ingediend
16 juni 2026
Eerst ingediend dat voldeed aan de QC-criteria
16 juni 2026
Eerst geplaatst (Werkelijk)
22 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
25 juni 2026
Laatste update ingediend die voldeed aan QC-criteria
22 juni 2026
Laatst geverifieerd
1 mei 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 06.12.2024/16
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .