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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
-
Tehran, Iran (Repubblica Islamica del, 19839
- Iranian Center for Endodontic research
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 1
ORCT
|
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.
Altri nomi:
|
|
Sperimentale: 2
PCEM/PMTA
|
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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Clinical and radiographical success of pulpotomy with CEM cement
Lasso di tempo: 5 year
|
5 year
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Patient Assessment of Pain - Visual Analogue Scale
Lasso di tempo: 7 day
|
7 day
|
Collaboratori e investigatori
Investigatori
- Direttore dello studio: Mohammad Jafar Eghbal, Prof., Shahid Beheshti University of Medical Sciences
- Investigatore principale: Jamileh Ghoddusi, Prof., Mashhad University Of Medical Sciences
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- C/B/4/8253
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .