Ignite Creation Date:
2024-05-06 @ 3:59 AM
Last Modification Date:
2024-10-26 @ 11:41 AM
Study NCT ID:
NCT02422823
Status:
COMPLETED
Last Update Posted:
2016-06-16
First Post:
2015-03-27
Brief Title:
Anesthetic Efficacy of 18mL and 36mL of Articaine in Inferior Alveolar Nerve Block in Irreversible Pulpitis
Sponsor:
Isabel Peixoto Tortamano
Organization:
University of Sao Paulo
Study Overview
Official Title:
Comparative Evaluation of the Anesthetic Efficacy of 18mL and 36mL of 4 Articaine With 1 100000 Epinephrine in Blocking the Inferior Alveolar Nerve in Patients With Irreversible Pulpitis of Mandibular Molars
Status:
COMPLETED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Volumes
Brief Summary:
Ninety patients with irreversible pulpitis diagnostic will participate in this clinical study The participants will be divided into 2 groups of 45 patients who will receive the inferior alveolar nerve block injections of 18 mL of 4 articaine Articaine 100 DFL Rio de Janeiro RJ Brazil with 1100000 epinephrine or 36mL of the same solution Two consecutive negative responses to the maximum pulp stimulus 80 µA at the electric pulp test were the criterion to determine a pulpal anesthesia as successful Ten minutes after the IAN block subjective lip anesthesia will be evaluated by asking the patient whether hisher lip was numb Thereafter and immediately before the pulpectomy the electric pulp stimulations will be repeated to determine pulpal anesthesia During the pulpectomy procedure the patients were instructed to report any painful discomfort To evaluate the intensity of pain during the pulpectomy a verbal analogue scale will be used The anesthesia will be defined as successful when the dentist accessed the pulp chamber without pain being reported by the patient In these cases the pulpectomy will be continued If report pain will classified the IAN block as unsuccessful
Detailed Description:
Ninety patients will Participate in this clinical study The patients will be admitted to the Emergency Center of the School of Dentistry at the University of São Paulo with a clinical diagnosis of irreversible pulpitis The study was approved by the Committee on the Ethics of Research on Human Beings of the School of Dentistry at the University of São Paulo protocol 9507 and each patient will be informed to sing consent to participate in the study The 90 participants will be divided into 2 groups of 45 patients who will receive the inferior alveolar nerve block injections of 18 mL equivalent to 1 cartridge of 4 articaine Articaine 100 DFL Rio de Janeiro RJ Brazil with 1100000 epinephrine or 36mL equivalent to 2 cartridges of the same solution Two consecutive negative responses to the maximum pulp stimulus 80 µA at the electric stimulation were the criterion to determine a pulpal anesthesia as successful Before the IAN block injections the tooth with irreversible pulpitis the adjacent tooth and the contralateral canine will be tested for pulp vitality with an electric pulp test Vitality Scanner 2006 SybronEndo Orange CA The electric pulp stimulation of the contralateral canine which will be not anesthetized will be used as control to ensure that the equipment is working properly and that patients is responding adequately
The average injection time for each cartridge was approximately 2 minutes Ten minutes after the IAN block subjective lip anesthesia will be evaluated by asking the patient whether hisher lip was numb Thereafter and immediately before the pulpectomy the electric pulp stimulations will be repeated to determine pulpal anesthesia During the pulpectomy procedure the patients were instructed to report any painful discomfort To evaluate the intensity of pain during the pulpectomy a verbal analogue scale will be used 0 no pain 1 mild bearable pain 2 moderate unbearable pain 3 severe intense and unbearable pain The anesthesia will be defined as successful when the dentist accessed the pulp chamber without pain being reported by the patient pain scores 0 or 1 In these cases the pulpectomy will be continued Pain scores of 2 or 3 will classified the IAN block as unsuccessful
The average injection time for each cartridge was approximately 2 minutes Ten minutes after the IAN block subjective lip anesthesia will be evaluated by asking the patient whether hisher lip was numb Thereafter and immediately before the pulpectomy the electric pulp stimulations will be repeated to determine pulpal anesthesia During the pulpectomy procedure the patients were instructed to report any painful discomfort To evaluate the intensity of pain during the pulpectomy a verbal analogue scale will be used 0 no pain 1 mild bearable pain 2 moderate unbearable pain 3 severe intense and unbearable pain The anesthesia will be defined as successful when the dentist accessed the pulp chamber without pain being reported by the patient pain scores 0 or 1 In these cases the pulpectomy will be continued Pain scores of 2 or 3 will classified the IAN block as unsuccessful
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None