TheraCal Materials Versus MTA in Full Pulpotomy
22. juni 2026 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
72
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Sarıçam
-
Adana, Sarıçam, Tyrkia (Türkiye), 01250
- Cukurova University
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: 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.
|
|
Eksperimentell: 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.
|
|
Eksperimentell: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Postoperative Pain Intensity Assessed by Visual Analogue Scale
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Koray Yılmaz, DDS, MSc, Professor, Cukurova University
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
16. desember 2024
Primær fullføring (Faktiske)
18. juni 2025
Studiet fullført (Faktiske)
6. april 2026
Datoer for studieregistrering
Først innsendt
16. juni 2026
Først innsendt som oppfylte QC-kriteriene
16. juni 2026
Først lagt ut (Faktiske)
22. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
25. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
22. juni 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 06.12.2024/16
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .