Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2025-12-30 @ 9:49 PM
Study NCT ID:
NCT06790433
Status:
COMPLETED
Last Update Posted:
2025-01-24
First Post:
2025-01-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between the Dentapen and Vibraject
Sponsor:
Riyadh Elm University
Organization:
Study Overview
Official Title:
Comparison Between the Dentapen and Vibraject: a Randomized Clinical Study on the Administration of Local Anaesthesia in Adult Patients.
Status:
COMPLETED
Status Verified Date:
2025-01
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:
None
Brief Summary:
A split-mouth, controlled trial aimed to assess patient-reported pain levels during local anaesthesia administration to the buccal side of the maxillary posterior teeth using Vibraject-assisted injection and the Dentapen® system in its ramp-up mode.
Pain intensity was evaluated using the Visual Analogue Scale immediately following each injection, and heart rate measurements were recorded before and after each injection. Patient preferences for injection methods were also documented
Pain intensity was evaluated using the Visual Analogue Scale immediately following each injection, and heart rate measurements were recorded before and after each injection. Patient preferences for injection methods were also documented
Detailed Description:
Steps of the Experiment
The experimental protocol was meticulously structured to evaluate the efficacy and patient response to two different local anaesthetic delivery systems. The steps were as follows:
Step I: Before administering a local anaesthetic, the patient's heart rate was checked with a pulse oximeter (Beurer Finger Pulse Oximeter). The results were recorded.
Step II: Patients were randomly assigned to get the injection of local anaesthetic at their initial appointment either with the Dentapen system (ramp-up) or with Vibraject. To simplify the protocol, a 27-gauge needle was used for all dental injections with bevel side directly headed to the injected site.
Step III: In the next appointment, after of one hour on a digital timer, the other technique was used for the same patients on the other side. Hence, each patient was given local anaesthesia twice, once with the Dentapen system (ramp-up mode) and once with Vibraject.
Step IV: Immediately after each local anesthesia injection operation, the patient was asked to use the Visual Analogue Scale to score the intensity of reported pain.
Step V: After administering a local anaesthetic, the patient's heart rate was measured with a pulse oximeter (Beurer Finger Pulse Oximeter). The results were recorded.
Step VI: After both injections were administered to each patient, they were asked which injection they would prefer by selecting the injection number (first or second) according to their order for each patient.
The experimental protocol was meticulously structured to evaluate the efficacy and patient response to two different local anaesthetic delivery systems. The steps were as follows:
Step I: Before administering a local anaesthetic, the patient's heart rate was checked with a pulse oximeter (Beurer Finger Pulse Oximeter). The results were recorded.
Step II: Patients were randomly assigned to get the injection of local anaesthetic at their initial appointment either with the Dentapen system (ramp-up) or with Vibraject. To simplify the protocol, a 27-gauge needle was used for all dental injections with bevel side directly headed to the injected site.
Step III: In the next appointment, after of one hour on a digital timer, the other technique was used for the same patients on the other side. Hence, each patient was given local anaesthesia twice, once with the Dentapen system (ramp-up mode) and once with Vibraject.
Step IV: Immediately after each local anesthesia injection operation, the patient was asked to use the Visual Analogue Scale to score the intensity of reported pain.
Step V: After administering a local anaesthetic, the patient's heart rate was measured with a pulse oximeter (Beurer Finger Pulse Oximeter). The results were recorded.
Step VI: After both injections were administered to each patient, they were asked which injection they would prefer by selecting the injection number (first or second) according to their order for each patient.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: