- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07808684
Impact of Cross-Sectional Design in Single-File Rotary System on Apical Debris Extrusion
Impact of Cross-Sectional Design in Single-File Rotary System on Apical Debris Extrusion and Postoperative Pain Following Single-Visit Root Canal Treatment: An In Vitro and Randomized Clinical Study
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Root canal shaping represents a critical phase in endodontic treatment, as it facilitates effective cleaning and disinfection while preserving the original canal anatomy. The objective is to create a continuously tapered conical shape from coronal to apical regions without inducing procedural errors such as canal transportation, ledge formation, zipping, or perforation.
With advancements in nickel-titanium (NiTi) technology, modern rotary systems have been developed to enhance shaping efficiency, improve debris removal, and reduce preparation time. Recently, single-file rotary systems have gained popularity due to their simplified protocols, reduced instrument fatigue, and improved clinical efficiency.
A novel concept in instrument design involves flat-sided rotary files manufactured from proprietary heat-treated NiTi alloys, such as AF One Blue and Platinum V.EU. These instruments exhibit a modified S-shaped cross-section with an inactive tip and a distinctive flat surface. The flat-sided design reduces the metal mass of the instrument, potentially enhancing flexibility, cyclic fatigue resistance,and facilitating coronal transportation of debris during instrumentation.
In contrast, One Curve is a single-file rotary system manufactured from heat treated C-wire alloy, which offers controlled memory properties, improved flexibility, and enhanced resistance to cyclic fatigue. It operates in continuous rotation and features a variable cross-sectional design that promotes efficient cutting while maintaining effective debris removal during canal preparation.
Apical extrusion of debris is an inevitable consequence of root canal instrumentation. The extrusion of dentinal debris, microorganisms, and irrigants beyond the apical foramen may induce an inflammatory response in the periapical tissues, which is considered a major contributing factor to postoperative pain. The amount of apically extruded debris has been shown to vary according to the design and kinematics of the instrumentation system used.
Despite the continuous evolution in instrument design, there is limited evidence regarding the influence of flat-sided rotary systems compared to non-flat cross-sectional systems on apical debris extrusion and postoperative pain,particularly in curved canals. Furthermore, the potential relationship between debris extrusion and the severity of postoperative pain remains insufficiently explored.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Nahla Nasr El-Din Fouad Mohamed, MSC
- Numéro de téléphone: +201009067349
- E-mail: nannanasr248@gmail.com
Sauvegarde des contacts de l'étude
- Nom: Dalia Ali Mokarab, M.D
- Numéro de téléphone: +201068121523
- E-mail: dalia.mokarab@mu.edu.eg
Lieux d'étude
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Minya Governorate
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Minya, Minya Governorate, Egypte
- Recrutement
- Endodontics, Faculty of Dentistry, Minia University
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Contact:
- Dalia Ali Mokarab, M.D
- Numéro de téléphone: +201068121523
- E-mail: dalia.mokarab@mu.edu.eg
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Contact:
- Ahmed Ali Yossef, M.D
- Numéro de téléphone: +201007335293
- E-mail: ahmed.yousef@mu.edu.eg
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La description
Inclusion Criteria:
- Teeth with mature apex
- Straight root canal or mild curvature not exceeding(5-10) Schneider.
- Has intact crown ( coronal structure)
- Presence of one orifices and one apices, patency achieved by a #10-15 K-file to the apical foramen
Exclusion Criteria:
- Previous root canal treatment.
- Internal/external resorption.
- Immature root apices.
- Caries/cracks/fractures on the root surface.
- Root canal curvature more than 10 degrees.
- Teeth in which the apical minor constriction was gauged larger than a size 20 hand file.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: one curve file
About 15 cases will be subjected to one single file to the full working length.
File will be operated at 300 rpm/2.5 Ncm torque in continuous rotation
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to evaluate and compare the amount of apically extruded debris using the AF One single-file rotary system, featuring a flat-sided design, and the One Curve rotary system in curved mesiobuccal canals of mandibular first molars.
Additionally, this study aims to assess postoperative pain associated with both systems and to investigate the potential correlation between apical debris extrusion and postoperative pain.
Autres noms:
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Comparateur actif: AF Fanta flat sided file system
About 15 cases will be subjected to one single file to the full working length.File will be operated at 300 rpm/2.5 Ncm torque in continuous rotation
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to evaluate and compare the amount of apically extruded debris using the AF One single-file rotary system, featuring a flat-sided design, and the One Curve rotary system in curved mesiobuccal canals of mandibular first molars.
Additionally, this study aims to assess postoperative pain associated with both systems and to investigate the potential correlation between apical debris extrusion and postoperative pain.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Treatment of Postoperative Pain
Délai: from 0 hours to 1 week after the procedure
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Pain scores will be recorded on Visual Analog Scale (VAS) using a 0 to 10 pain score basis with 0 being no pain and 10 being the worst pain.
Recording will be done everyday for 7 days period.
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from 0 hours to 1 week after the procedure
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chaise d'étude: Maged Mohamed Negm, Professor, Endodontics Department, Faculty of Dentistry, Cairo University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
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
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Single-File Rotary System
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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