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.

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

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Device: Vibraject; Device: Dentapen

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia, 84891
    • Dental Hospitals - Riyadh Elm University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Individuals classified under American Society of Anesthesiologists classes I and II, indicating a healthy or mild systemic disease status.
• Individuals aged from 18 up to 65 years, encompassing both male and female patients.
• Individuals who required local anesthetic injections bilaterally in the buccal side of the upper posterior teeth. These injections were necessary for various dental procedures, including restorative, endodontic, or prosthodontic treatments, and volunteers as well were to be administered across both sides of upper posterior teeth.
• Individuals must be in good health, not currently taking any medication, and have no contraindications to the use of local anesthesia.
• Individuals who have the ability to understand both oral and written instructions, ensuring effective communication and comprehension throughout the study.

Exclusion Criteria:

• Individuals with allergies to local anesthetics, this is to prevent adverse reactions.
• Pregnant or nursing women, this is to avoid any potential risks to their health or that of their infants.
• Individuals who were actively taking drugs that could alter pain perception or anxiety levels, such as nonsteroidal anti-inflammatory drugs, opioids, or antidepressants. This was to ensure that the study's findings on pain perception were not influenced by external substances
• Individuals with heavy alcohol consumption. .
• Patients with active pathologies at the injection site, this is to avoid complications and to ensure the accuracy of the study's results.
• Individuals who could not commit to the study's schedule or were unable to give informed consent. This ensured that all participants were fully aware of and agreeable to the study's procedures and requirements.
• Patients who required intravenous sedation for their dental procedures.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Vibraject; Participants will receive dental injection using Vibraject	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
Active Comparator: Dentapen; Participants will receive dental injection using Dentapen	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	Heart rate was measured for the participants using a pulse oximeter	Immediately after the intervention/procedure (dental anesthesia)
Pain rating scale	After each local anesthesia injection operation, the patient was asked to use the Visual Analogue Scale to score the intensity of reported pain. It is a scale of pain composed of 10 scores from 0 to 10, a higher score indicates greater pain intensity (worse outcome).	3 minutes after the intervention/procedure (dental anesthesia)
Participant's future preference	The participants were asked using a simple questionnaire to state their preference for the delivery system of future injections	5 minutes after the intervention/procedure (dental anesthesia)

Collaborators and Investigators

• Sponsor: Riyadh Elm University
• Investigators: Study Director: ِAmmar AbuMostafa, MSc, Riyadh Elm University

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2023
• Primary Completion (Actual): December 30, 2023
• Study Completion (Actual): February 2, 2024

Study Registration Dates

• First Submitted: January 9, 2025
• First Submitted That Met QC Criteria: January 21, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 21, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: dental injection
• Other Study ID Numbers: Dr Ammar's - Anesthesia 2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No