NCT06790433

Comparison Between the Dentapen and Vibraject

Comparison Between the Dentapen and Vibraject: a Randomized Clinical Study on the Administration of Local Anaesthesia in Adult Patients.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Riyadh Elm University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

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.

Conditions

• Pain

Interventions

Type	Name	Description
DEVICE	Vibraject	The needle was advanced into the tissue until it was estimated to be over the root apex while remaining parallel to the tooth's long axis. The Vibraject was activated after aspiration to deposit the solution slowly at approximately 50 seconds. Following cartridge deposition, the operator adjusted the participant to an upright seated position
DEVICE	Dentapen	The needle was advanced into the tissue until it was estimated to be over the root apex while remaining parallel to the tooth's long axis (needle placement). The Dentapen was activated after aspiration to deposit the solution at a medium rate (1 mL/60 s) using the ramp-up mode. Following cartridge deposition, the operator adjusted the participant to an upright seated position

Timeline

• Start date: 2023-10-15
• Primary completion: 2023-12-30
• Completion: 2024-02-02
• First posted: 2025-01-24
• Last updated: 2025-01-24

Locations

1 site across 1 country: Saudi Arabia