Comparison Between the Dentapen and Vibraject

NCT ID: NCT06790433

Last Updated: 2025-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-15
• Study Completion Date: 2024-02-02

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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Vibraject

Participants will receive dental injection using Vibraject

Group Type: ACTIVE_COMPARATOR

Vibraject

Intervention Type: DEVICE

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

Dentapen

Participants will receive dental injection using Dentapen

Group Type: ACTIVE_COMPARATOR

Dentapen

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: 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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Riyadh Elm University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ِAmmar AbuMostafa, MSc

Role: STUDY_DIRECTOR

Riyadh Elm University

Locations

Dental Hospitals - Riyadh Elm University

Riyadh, , Saudi Arabia

Countries

Saudi Arabia

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

Dr Ammar's - Anesthesia 2025

Identifier Type: -

Identifier Source: org_study_id