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- Essai clinique NCT07852260
Evaluation of Postoperative Pain and the Antimicrobial Effect of Super Oxidized Water (Microcyn) and Chlorhexidine When Compared With Sodium Hypochlorite in Teeth With Asymptomatic Necrotic Pulps. A Randomized Clinical Trial (NRS)
Evaluation of Postoperative Pain and the Antimicrobial Effect of Super Oxidized Water (Microcyn) and Chlorhexidine When Compared With Sodium Hypochlorite in Teeth With Asymptomatic Necrotic Pulps A Randomized Clinical Trial
The objective of this study is to evaluate the postoperative pain and antimicrobial efficacy when using super-oxidized water (Microcyn) and 2% Chlorhexidine as irrigating solutions in comparison to 2.5% Sodium hypochlorite in teeth with asymptomatic necrotic pulps.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
The objective of this study is to evaluate the postoperative pain and antimicrobial efficacy when using super-oxidized water (Microcyn) and 2% Chlorhexidine as irrigating solutions in comparison to 2.5% Sodium hypochlorite in teeth with asymptomatic necrotic pulps.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Paunceh S Soliman, PHD candidate
- Numéro de téléphone: 01026999750
- E-mail: paunceh.soliman@dentistry.cu.edu.eg
Lieux d'étude
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Cairo Governorate
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Cairo, Cairo Governorate, Egypte, 11553
- faculty of Dentistry Cairo university
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Contact:
- Paunceh S Soliman, PHD candidate
- Numéro de téléphone: 01026999750
- E-mail: paunceh.soliman@dentistry.cu.edu.eg
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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:
- Patients in good physical health; American Society of Anesthesiologists (ASA) class I or II.
- Patients whose age ranges between 18 and 50 years.
- Male and female patients.
- Patients having a single canal-tooth with asymptomatic necrotic pulp.
- Patients who can understand the number rating scale.
- Patients who accept to participate in the trial and can sign the informed consent
Exclusion Criteria:
- Pregnant females.
- Patients with intraoral or extraoral swelling.
- Patients whose tooth is non-restorable.
- Teeth with open apices.
- Teeth with radiographic evidence of root resorption.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation factorielle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Group A
Each canal will receive 2ml of super-oxidized water (Microcyn) irrigating solution between each instrument size and the subsequent one. |
The difference in concentration of chlorine between NaOCl and super oxidized water such that the concentration of chlorine ions in NaOCl is much higher than that in super-oxidized water. However, considering the 90% reduction in biofilm thickness and 98% reduction in colony count of microorganisms by super-oxidized water as demonstrated |
|
Comparateur actif: Group B
Each canal will receive 2ml of 2% chlorhexidine irrigating solution between each instrument size and the subsequent one. |
Chlorhexidine (CHX) has been indicated as an alternative irrigation agent in the preparation of the root canal system, due to its broad-spectrum antimicrobial capacity, dentin tubule disinfection, dentin adsorption, high substantivity, and low toxicity compared to NaOCl. The inability to dissolve organic tissues of the CHX provides controversial in the use of this irrigant, and due to this limitation, some authors do not indicate it as the main irrigation solution in endodontic treatment despite its utility as a final irrigation solution. |
|
Comparateur actif: Group C
Each canal will receive 2ml of 2.5 % sodium hypochlorite irrigating solution between each instrument size and the subsequent one. |
Sodium hypochlorite (NaOCl) is the most common and has been widely used in endodontics for more than 70 years because of its ability to act as a solvent for organic matter and its efficient antimicrobial action, however, at high concentrations, it is likely to irritate periradicular tissues. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Postoperative pain intensity at 6 hours post-instrumentation
Délai: 6 hours post-instrumentation
|
A pain chart using numerical rating scale (NRS) will then be used to record the patients' pain level. The NRS (0-10 scale) consists of a line anchored by two extremes "No pain" and "the worst pain". Patients will be asked to choose the mark that represented their level of pain from 0 to 10. Pain level will be assigned as follow: 0: no pain, 1-3: mild pain, 4-6: moderate pain, 7-10: severe pain. |
6 hours post-instrumentation
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
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
- La douleur
- Manifestations neurologiques
- Complications postopératoires
- Processus pathologiques
- Conditions pathologiques, signes et symptômes
- Signes et symptômes
- Douleur, Postopératoire
- Produits chimiques inorganiques
- Composés de chlore
- Oxydes
- Composés d'oxygène
- Acide hypochlouleux
- Composés de sodium
- Hypochlorite de sodium
Autres numéros d'identification d'étude
- Paunceh samy
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
There is no plan to share individual participant data (IPD) with other researchers due to participant confidentiality and privacy considerations.
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
produit fabriqué et exporté des États-Unis.
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