Comparison Between the Dentapen and Vibraject

NCT06790433 | Completed DMC

• 1 other identifier: Dr Ammar's - Anesthesia 2025
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Pain

Keywords

dental injection

Outcome Measures

Primary Outcomes (3)

• 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)

Study Arms (2)

Vibraject

ACTIVE COMPARATOR

Participants will receive dental injection using Vibraject

Device: Vibraject

Dentapen

ACTIVE COMPARATOR

Participants will receive dental injection using Dentapen

Device: Dentapen

Interventions

Vibraject 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

Vibraject

Dentapen 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

Dentapen

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riyadh Elm University: lead

Study Sites (1)

Dental Hospitals - Riyadh Elm University

Riyadh, 84891, Saudi Arabia

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• ِAmmar AbuMostafa, MSc

  Riyadh Elm University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 24, 2025
• Study Start: October 15, 2023
• Primary Completion: December 30, 2023
• Study Completion: February 2, 2024
• Last Updated: January 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)