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Search / Trial NCT06790433

Comparison Between the Dentapen and Vibraject

Launched by RIYADH ELM UNIVERSITY · Jan 21, 2025

Trial Information

Current as of June 26, 2025

Completed

Keywords

Dental Injection

ClinConnect Summary

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 u...

Gender

ALL

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.

About Riyadh Elm University

Riyadh Elm University is a leading educational and research institution in Saudi Arabia, dedicated to advancing healthcare through innovative clinical research and evidence-based practice. Committed to fostering academic excellence and community health, the university collaborates with local and international partners to conduct clinical trials that aim to improve patient outcomes and contribute to the global body of medical knowledge. With a focus on ethical standards and regulatory compliance, Riyadh Elm University seeks to drive advancements in medical science while prioritizing the safety and well-being of participants involved in its research initiatives.

Locations

Riyadh, , Saudi Arabia

Patients applied

0 patients applied

Trial Officials

ِAmmar AbuMostafa, MSc

Study Director

Riyadh Elm University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported