An interventional study of Vibraject and Dentapen in Pain, sponsored by Riyadh Elm University. Completed at 1 site in Saudi Arabia. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-24.
Sponsored by Riyadh Elm University · Not applicable, Interventional, and Treatment
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
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.
2,450 studies on the registry are indexed under Pain; 945 are open to participants now.
This study's enrollment of 40 is below the median of 70 across 2,101 interventional studies indexed under Pain.
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Exclusion Criteria:
Participants will receive dental injection using Vibraject
Device: Vibraject
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. 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
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
Heart rate
Heart rate was measured for the participants using a pulse oximeter
Time frame: 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).
Time frame: 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
Time frame: 5 minutes after the intervention/procedure (dental anesthesia)
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Ran from Oct 2023 to primary completion in Dec 2023, 2 months.
Of 1,253 non-industry interventional studies with no phase under Pain, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 29. This study's 2 months is below that.
Counting every sponsor, half of 1,276 studies reached it within 11 months; a quarter within 5 and three quarters within 30.
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This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Riyadh Elm University