- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00748280
Vital Pulp Therapy to Treat Irreversible Pulpitis (VPT)
Pulpotomy Versus Root Canal Therapy to Treat Irreversible Pulpitis in Human Permanent Molars: A Multicenter Randomized Non-inferiority Trial.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
In one visit RCT (Arm 1): The teeth were anesthetized, isolated and endodontic access and instrumentation of all canals was done. Canal preparation was conducted using a step-back technique. The working lengths were determined and confirmed by radiography. Sterile normal saline solution was used for intra-canal irrigation. Root canals were obturated with gutta-percha and sealer using lateral condensation technique. After placing a cotton pellet in the pulp chamber, the access cavity was closed with Cavit.
In pulpotomy treatment with CEM/MTA (Arm 2): The teeth were anesthetized. Pulpotomy procedure of removing inflamed pulp tissue to the stump level was done. Homeostasis was achieved by irrigating the cavity with sterile normal saline and application of small pieces of sterile cotton pellets. The pulpal wound was covered with an approximately 2-mm-thick layer of MTA/CEM cement. Pulp chambers were then covered with a wet cotton pellet and sealed with Cavit.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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-
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Tehran, Iran, Islamische Republik, 19839
- Iranian Center for Endodontic research
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
Diagnostic criteria:
- Patient reports pain of endodontic origin
- Diagnosis of irreversible pulpitis
Eligibility criteria:
- Molar tooth
- Patient chooses to have tooth extraction for pain relief
- Age 9-65 years
- Both gender
- The patient had read and thoroughly understood the questionnaires; and
- Written informed consent
Exclusion Criteria:
- Moderate or severe periodontitis
- None restorable tooth
- Internal or external root resorption
- Root canal calcification
- No bleeding after access cavity preparation
- Analgesic taken within the last 4 h
- Active systemic disease
- The patient was pregnant or nursing
- History of opioid addiction or abuse
- Temporary residency
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Versorgungsforschung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: 1
ORCT
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Teeth were isolated, caries was removed and access cavities were prepared.
Canal preparation was conducted using step-back technique.
The working lengths were determined and confirmed by radiographs.
The minimum size file for preparing the working length was size ISO #25 K-file to within 0.5-2 mm of the radiographic apex of the root.
During hand instrumentation, canals were frequently irrigated with adequate amount of sterile normal saline solution.
The root canals were filled with multiple gutta-percha cones and sealer using lateral condensation technique.
Placing a cotton pellet in the pulp chamber, the access cavity was temporarily filled.
The treatments of all samples were performed one-visit.
Andere Namen:
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Experimental: 2
PCEM/PMTA
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Pulpotomy was performed with a large round bur in a high-speed handpiece with copious irrigation; removing inflamed pulp tissue to stump level.
Hemostasis was achieved by irrigation of the cavity with sterile normal saline and application of small pieces of sterile cotton pellets.
The blood clot-free pulpal wound was covered with approximately 2 mm layer of endodontic bio-materials, a sterile wet cotton pellet was then placed over the MTA/CEM cement and the cavity sealed with Cavit.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Clinical and radiographical success of pulpotomy with CEM cement
Zeitfenster: 5 year
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5 year
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Patient Assessment of Pain - Visual Analogue Scale
Zeitfenster: 7 day
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7 day
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Mitarbeiter und Ermittler
Ermittler
- Studienleiter: Mohammad Jafar Eghbal, Prof., Shahid Beheshti University of Medical Sciences
- Hauptermittler: Jamileh Ghoddusi, Prof., Mashhad University Of Medical Sciences
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- C/B/4/8253
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