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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Tehran, Iran (République islamique d, 19839
- Iranian Center for Endodontic research
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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.
Autres noms:
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Expérimental: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Clinical and radiographical success of pulpotomy with CEM cement
Délai: 5 year
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5 year
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Patient Assessment of Pain - Visual Analogue Scale
Délai: 7 day
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7 day
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Collaborateurs et enquêteurs
Les enquêteurs
- Directeur d'études: Mohammad Jafar Eghbal, Prof., Shahid Beheshti University of Medical Sciences
- Chercheur principal: Jamileh Ghoddusi, Prof., Mashhad University of Medical Sciences
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- C/B/4/8253
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